Generic filters

Challenges facing European Pharmaceutical Manufacturers in 2022

Pharmacentral Reporters

In the run-up to Christmas, there was considerable anxiety about shortages of all sorts of goods, from toys, food, and medical supplies. These were down to supply chain pinch points, exacerbated by the global pandemic, and multiple other factors that all came to a head in Q3 and 4.

As Europe settles into 2022, pharmaceutical manufacturers are a vertical that face specific challenges. We polled representatives from across the sector, from CROs, CDMOs, generic and R&D intensive manufacturing companies. Here are the highlights of what we found out.

Supply chains

The Covid-19 pandemic has affected every part of the manufacturing value chain, from raw material to end customers. Companies are reporting continued disruptions in global logistics which are impacting the flow of raw materials and goods due to congestion and shutdowns at major global ports and airports, largely in China, South Korea, and the US.

As the year progresses, these disruptions will lessen, and access to sea and airfreight will improve back to pre-pandemic levels, but companies can still expect to see higher input prices (as excessive freight costs are passed on), and longer lead times because of the length it takes to clear logjams in the supply chain.

Sustainability goals

COP26 has provided new impetus for action on sustainability, and many companies have committed to ambitious goals. Turning these commitments into tangible goals requires companies to work with suppliers that adhere to social and environmental standards. However, firms face special challenges governing lower-tier suppliers (lower down the value chain) due to absence of direct contractual relationships. Often, lower-tier suppliers are the least equipped to handle sustainability requirements.

Skilled labour shortages

Having a qualified workforce is essential to ensuring the high levels of quality required in the pharmaceutical industry are met. However, many companies are reporting shortages, both for white and blue collared workers, in terms of both skills and numbers. Uncertainties over the last years have exacerbated shortages but there are several other non-COVID-19 related factors at play, including changes in demographics.

Manufacturing flexibility

As the past two years have demonstrated, resilience is predicated on agility and adaptability rather than impregnability. In order to rapidly respond to evolving market dynamics, pharmaceutical manufacturers need to transform their manufacturing models into those that are flexible, using production methods designed to easily adapt to changes in the type and quantity of the product being manufactured. However, while desired, flexibility is not that easy to pull off in a highly regimented sector that is pharma. Changes to decades-old and established methodologies require fresh and expensive regulatory scrutiny. Importantly, new, and specialised machinery need to be purchased and installed to allow for this level of customization, and not every firm has access to finance or the manpower to achieve this transformation within the needed timelines.

Final thoughts

The pandemic has brought to the fore the vulnerabilities of European pharmaceutical market. Issues such as supply chain are transient whereas changing demographics, mainly from aging and retiring workers, as well as border and immigration controls, are structural. Going forward, it will be necessary to formulate a suitable policy mix to address these challenges.


  1. GlobalData, 2021. COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships. [online]. Available at:
  2. CPhI, 2021. Pharma Trends 2022. [online] CPhI, pp.6-7, 16. Available at…[Accessed 10 January 2022].

January 2022 CHMP Meeting Highlights

The CHMP is the European Medicines Agency’s (EMA) committee responsible for human medicines. It plays a key role in authorisation of medicines in the European Union. The CHMP meets once a month to exercise its duties. Click here to download CHMP’s meeting dates.

In its latest meeting, CHMP recommended seven new medicines for approval, including the antiviral Paxlovid (PF-07321332/ritonavir) for COVID-19 and Breyanzi (lisocabtagene maraleucel), a gene therapy for large B-cell lymphomas.



PAXLOVID™ (Nirmatrelvir and Ritonavir) – Pfizer

The committee recommended granting conditional marketing authorisation to Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Paxlovid is the first oral antiviral recommended for treating COVID-19 in the EU and contains two active substances, Nirmatrelvir and ritonavir. Nirmatrelvir reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of Nirmatrelvir.

The decision was based on trial results in which Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19. Over the month following treatment, the rate of hospitalisation or death was 0.8 percent (8 out of 1,039) for Paxlovid recipients and 6.3 percent (66 out of 1,046) for placebo. There were no deaths with Paxlovid and 12 deaths in the placebo group.


BREYANZI® (Lisocabtagene maraleucel) – Bristosl Myers Squibb

BREYANZI® is an immune-cell-based gene therapy. A patient’s T cells are extracted and genetically engineered to express a chimeric antigen receptor (CAR) protein that allows them to target and eliminate cancer cells, before being reinfused in the patient.

Breyanzi had PRIME designation and benefited from early and enhanced dialogue between the EMA and its developers. A positive opinion was given to Breyanzi for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment.

The CHMP based the decision on the safety of Breyanzi, examined in four studies involving over 300 treated patients, and the efficacy in two studies pooling about 350 patients. The efficacy trials concluded that clinical benefit would be expected with a meaningful disease control in a substantial proportion of patients.

Biosimilars and Generics

CHMP adopted a positive opinion, and recommended the granting of marketing authorisations for the following biosimilars/generics:

Sondelbay (Teriparatide) for the treat osteoporosis and Stimufend (Pegfilgrastim) for the reduction of the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy were the two biosimilars that received recommendations for approval.

Dasatinib Accord (Dasatinib) for the treatment of leukaemia, and Vildagliptin/Metformin hydrochloride for the treatment of type 2 diabetes. Dasatinib Accord is a generic of Sprycel, which has been authorised in the EU since 20 November 2006.

Indication Extensions

Eight medicines were recommended for indication extensions, namely Ayvakyt, Briviact, Dupixent, Jardiance, Lacosamide, Senshio, Tecfidera and Vimpat.

Miscellaneous Actions

Rotterdam Biologics B.V., the applicant for Ipique (Bevacizumab) requested a re-examination of the committee’s earlier opinion not to grant an authorisation.

CHMP completed a review of Nasolam (Midazolam, Nasal spray) and concluded that the benefits of this medicine outweigh its risks and that marketing authorisations should be granted in those Member States of the EU where the company has applied.

CHMP concluded, following it’s review of Stresam (Etifoxine), that the medicine can continue to be used for the treatment of anxiety disorders but must not be used in patients who previously had severe skin reactions or severe liver problems after taking etifoxine.

Are You A Scientist Facing Online Harassment? Here Are 7 Strategies To Help You Cope

Sridhah Naminathan, PhD

Clinical Psychologists & Advanced Practitioner,  Glasgow, UK


If you or someone you know is experiencing online harassment, remember that you are not powerless. There are concrete steps you can take to defend yourself and others. The guidance below will help you decide how to act if you, or one of your colleagues or students, is affected by this.

Last week, a 24 year old man from the Essex market town of Chelmsford, 40 miles east of London, UK was sent to jail after admitting harassing the Professor Chris Whitty, the epidemiologist and Chief Scientific Advisor to the UK’s Department of Health & Social Care.

Footage that emerged last year had showed Mr. Jonathan Chew, together with his accomplice, Mr. Lewis Hughes, attacking Whitty, and holding him.

Luckily for the many of us not in the direct limelight, physical attacks such as those on Whitty are relatively rare. But we can relate to online attacks, either directly or on those we know. Online attacks at scientists and academics have become a major issue today, and going by the number of posts online, the signs are that things are not abating.

In a 2021 study by Nature, many scientists reported receiving death threats, hateful slurs, and physical intimidation or threats of sexual violence. Many scientists with a public profile have experienced some form of attack on their credibility or been threatened with violence.

Online abuse is not new-it begun with the arrival of the internet, the difference is that the problem is growing. In the middle of a global pandemic, conditions have become ripe for online conspiracy theories, hate and harassment, fuelled polarisation around vaccines and treatment options.

These attacks pose a direct and critical threat to free expression, and are an attempt to stifle the voice of science, by intimidating experts that provide the public with the information and guidance needed by governments and the public.

Against this background, I spoke with experts and survivors of online harassment to compile a quick list of tips and resources for coping with online abuse without being silenced or forced offline.

If you or someone you know comes under attack, here are some of the steps you can take to protect yourself and others.

Identify the threat

The first step is to make out what’s really happening. Is it simply an unkind remark (“You’re not a good scientist” “Where did you train from?”), a disparaging comment? (“You’re a fool!”) or categorically abusive, for example, gendered or racist?

Online abuse covers many behaviours and technologies. It happens when a person (or bot) acts in a manner that causes distress and harm to another person. It is usually repeated and targeted, but may not always be obvious. Some of the common tactics — albeit ever-evolving and often overlapping — include: hateful speech, sexual harassment, threats of physical and sexual violence, impersonation, doxing, pornography, message bombing, and many more. You can find detailed guidance here.

The bottom line is that if you’re being criticised or insulted, you can choose to refute it or ignore it. If the attack is sinister and you’re being abused, distilling what you’re experiencing not only signals that it’s a tangible problem, but can also help you communicate with family, friends, employers, and authorities.

Document the attacks

What is often overlooked is platforms take down abusive content that violets their terms of service, meaning that any evidence you might have of the abuse is removed. For this reason, it’s necessary to have a separate log of the abuse before you report it. You should aim to save emails, voicemails, and texts. For social media, take screenshots on and copy links, if possible. Where the abuse is coming from one specific individual or group, you should document it as thoroughly as possible as this can help uncover any patterns and shore up evidence.

A record of abuse is indispensable if you chose to engage authorities or take legal action. It can also be hugely helpful in conversations with line managers at work, as it obviates repeating abusive comments aloud, which is often unpleasant. Pointing to a screenshot is often less uncomfortable, and actually more impactful.

Review your personal safety

It is not impossible for online abuse to morph into physical abuse. Therefore, it is important to assess whether online abuse is presents a real danger to your own physical safety or that of your family or colleagues. Granted, online anonymity makes this onerous to figure out. Here are a set of questions to help you assess the significance of a threat, which you can do with a friend or colleague as a sounding board:

  • Do you know your abuser? Do they have a history of violent behaviour?
  • Is the threat targeted and specific? Does it include your name, a time, a place, or a method of attack?
  • Does the abuser seem irrational, for example, threatening you using their real name, email, or phone number?
  • Has the abuser migrated across platforms or moved offline (e.g., voicemails, physical mail, or packages left at your door or workplace)?

These are some of important red flags. They signal it’s time to take steps, particularly if you’re being made to feel physically unsafe in any way. You may need to temporarily relocate, such as a hotel or a friend’s place. You may also need to report the threats to authorities who are best positioned to deal, not just with online threats, but also physical dangers.

Ignore, block, mute, and report

Most bullies, perpetrators of online abuse are in it to get a reaction from you. Don’t play into their hands and get into a fight online. Sometimes, simply ignoring the comments can make the individual move on. You can also consider blocking, muting, and reporting abuse. Platforms offer option that allow you to block or mute accounts or even specific posts (so you don’t have to see them). You can report abuse that violates terms of service to try to get a post taken down or an account suspended.

Understandably, while helpful, these actions are temporary and often counterproductive. For instance, blocking an account can escalate abuse or move it offline. Muting can make it hard for you to monitor the scale of threats, and reporting is often ineffective.

Reinforce your online security

Just like physical security, taking time to bolster your online security can ensure trolls don’t get an easy ride accessing and broadcasting your private information. Protect yourself from hacks and intrusion by improving password strength (use long passwords which combine words and symbols with at least 12 characters), never re-use passwords, use invented answers to security questions, and set up two-factor authentication (OTP) on your key personal and professionnal accounts (email, social media, banking, etc.). A password manager is another tool you can use to take care of this.

Speak out

Speaking out against abuse can be empowering. The key is to be careful and deliberate. There are several strategies you can deploy. One option is to practice counterspeech, which you can read about through this link. Some people use highly creative strategies, such as sending a picture of a kitten or puppy in response to an abusive message, or telling the abuser that their mothers or employers will be notified about their unbecoming behaviour. Do what you’re comfortable with—being mindful of your employer’s social media policy.

Look after your wellbeing

Online abuse often elicits feelings of fear, self-loathing and guilt. It can be exhausting and demotivating, and leaving lasting damage to your mental, emotional, and physical health. The mistake is ignoring how you’re feeling.

Therefore, it’s important to make time for your wellbeing. This can include meditation, cooking, listening to music or going for walks. Whatever you choose, it must involve taking regular breaks from your devices so that you get that crucial mental headspace.

If matters escalate and you’re not coping, seeking professional mental health care can make a big difference, especially if you get to a point where you feel hopeless or paralyzed by fear, talk about your abuse obsessively, struggle to enjoy things, or have difficulty eating or sleeping.

And finally…

Every day, scientists in and out of the limelight hate and violent threats, and some of them choose to respond directly in order to refute or undermine it. If you’re affected, you don’t have to follow each every step listed above, let alone in the nominated order. It may well necessitate implementing a number of these in tandem or skipping some and coming back to others when they are most helpful. It is also important to remember that like many other aspects of human behaviour, trolling and online abuse are multifarious, and there is almost no way of predicting what an individual will do, or even prevent it. It is up to organisations, platforms, governments and wider society to recognise this and put into place the correct institutional mechanisms to address this scourge.

What I have suggested here is what you can do at an individual level. I hope that it offers you a good starting place if you’re experiencing abuse. With the right tools, support of others, and confidence in your own self, you can take a stand and push back against online abuse, and protect the voice of science.

Development of a Novel Coating for Conventional Non-Functional Applications

Yasuhiro Suzuki and Tatsuya Suzuki

Faculty of Pharmaceutical Science, Toho University


Despite the wide availability of alternative formats, solid dosage forms remain the most efficient methods for delivering drug substances into the body. Tablets and capsules are comparatively easy to manufacture, being relatively fast and easy to form, and from the consumer’s perspective, the most preferred approach due to their portability and ease of administration(1).

The vast majority of approved new drug products formulated as solid dosages forms are film coated. Film coatings perform a number of functions, including the following(2):

  • achieve controlled-drug release properties
  • aid identification and reduce medication errors (EU law requires all primary dosage forms to be identifiable to prevent medication errors)
  • delay drug release, for instance, enteric release properties
  • impart aesthetic features (colour & gloss) to allow branding
  • protect sensitive active ingredients from light, moisture or heat
  • mask unpalatable or odoriferous ingredients (e.g. garlic or fish liver oil)

Film Coatings Competitive Landscape

In 2018, the global market for pharmaceutical film coatings was dominated by non-functional coatings. This category accounts for approximately 70% of the total volume output. Functional and modifying coatings account for 14.9% of the annual output, while functional, non-modifying products are responsible for the rest (i.e 13.1%)(3,4). The different percentages are represented in figure 1 below.

In 2010, IMS Health (now IQVIA) estimated that the total global immediate-release film coating excipient market was around 25,000MT p.a. Approximately 65% of this output was supplied as ready-made dry powder mixes, which currently retail at $40.0 per kilo. By comparison, the modified-release film coating excipient market is smaller (approx. 6,000MT p.a). This is based on estimates of 1.7 trillion tablets coated with immediate release coatings compared to just 100 billion for the modified release coatings. Based on these calculations, the total market for pharmaceutical coatings is easily around $1 – 1.2 billion(6).

IR Applications (25,000MT) % MR Applications (3,000MT) % Non-coating Technologies (5,000MT) %
Aesthetics 60.0 Enteric 55.0 Matrix systems 70.0
Moisture Protection 15.0 Sustained release 15.0 Hydrogels 20.0
Taste/odour masking 10.0 Controlled release 28.0 Melt extrusion 5.0
Others 15.0 Others 2.0 Others 5.0

Focussing on non-functional coatings, there are several products currently available on the market. Examples of their main attributes are shown in the table below. All these systems are simple physical mixes of a polymer, a plasticizer, a detackifier and other materials (e.g colours, flavours, etc). Their main use is simple physical coating, applied via aqueous or organic solvent spray coating in heated rotating drums.

Product Eudragit EPO Sepifilm LP Opadry II (85)
Manufacturer Evonik Seppic Colorcon
Base polymer Aminomethacylic acid Hypromellose Poly(vinyl) alcohol
Other components Only base polymer is supplied Stearic acid, Talc & MCC Lecithin, PEG & Talc
Regulatory status Pharmaceuticals, Global coverage. Not food approved Both food, nutraceuticals & pharmaceuticals approval, Global coverage Not food approved. Pharmaceutical approval – Global coverage
Ease of use Very complex, multi-step preparation requiring detailed formulation & storage One-step preparation & application process. Approx. 45min preparation One-step preparation & application process. Approx. 45min preparation
Personalization Possible Possible Possible
Coating process time Fast (1 hr for 1 MT batch) Slow (2-3 hrs for 1 MT batch) Fast (1 hr for 1 MT batch)
Cost (/kg) $30 $35 $40

A list of existing suppliers and potential collaborators for this project is shown below:


# Name Comment
1 Biogrund GmbH

Small supplier of ready-made systems based in Germany. Recent alliance with Roquette may improve market standing and penetration. Currently focussed on Northern & Eastern Europe.


Limited supplier of ready-made systems. Main experience is in the development of polymers with the most recent ones being copies of Evonik pharmaceutical coating polymers. They have an immediate release polymer – PVA-PEG co-grafted polymer. Strength is in their polymer technical expertise. They are poor at supporting the sales and marketing of their products.

3 Colorcon*

Largest supplier of ready-made film coating systems globally. Not a polymer manufacturer but alliance with Dow provides a lower cost source of polymers. Colorcon have approximately 60% global market share in Immediate Release coating systems.

4 Evonik*

Specialists in development of coating polymers. They are technically very strong but do not get involved in manufacturing ready-made coating systems. They have an alliance with Colorcon to provide polymers for a fully pigmented enteric coating systems. They are the strongest supplier for enteric and sustained release coating systems.

5 Dupont (ex FMC Biopolymer)

Do not supply any pigmented film coating systems and do not have capability or current wish to provide this service. Only coating for Immediate Release is Lustre Clear – which has proved to be unsuccessful in the market place.

6 Ashland*

Formerly known as Hercules/ISP. Manufacture their own polymers and have set up colour matching and coating laboratories around the world. They are positioning themselves to take Colorcon on as a primary supplier of ready made, pigmented coating systems. One of the few companies who have a global sales and technical network

7 Ideal Cures

An Indian supplier of ready-made coating systems trying to break-out of their home market. Most success outside of India has been in the supply of coatings for nutritionals and to small generic companies in South Asian market.

9 Sensient

ex Warner Jenkinson. They do not supply complete film coating systems and since the company focus back to the US they have lost market share and company focus.

10 Seppic

French-based supplier of ready made film coating systems. Limited sales penetration with focus mainly in Southern Europe


Objectives of this work

The main objective of this work was to develop a conventional, non-functional coating system with demonstrable enhanced ease of use and minimal impact on dissolution rate and stability of model drug substances.

Research Methodology

 The approach taken to research and develop the new coating product is described below:

Coating formulation development

The initial work involved developing prototype formulations of the coating. This entailed screening three commonly used polymers, i.e poly(vinyl alcohol) 88% doh; aminomethacylic acid copolymer (Eudragit E) and hypromellose to which the required quantities of inclusives has been added, in accordance with the established practice of pharmaceutical coatings formulation. The representative formulae are shown below:

Standard Formulae adopted for screening coating systems (amounts in %)

Poly(vinyl alcohol) Aminomethacrylate Hypromellose
Polymer 40-80 40-80 40-80
Plasticizer 1-10 1-10 1-10
Surfactant 0-2 1-10 1-5
Carbohydrate 0-10 0-10 0-10
Bulking agent 1-10 5-20
Other materials 0-5 0-5 0-5


In addition, commercially available coating products, i.e Sepifilm (hypromellose-based); Opadry (poly(vinyl alcohol) based and Eudragit EPO (aminomethacrylate copolymer – based) were prepared in accordance with their respective vendor instructions and used as comparators in this work. Methods of preparation and coating are widely reported in the literature and will not be repeated here.

A list of materials and their purposes is provided in the table below:

# Name Purpose
1 Polaxamer Surfactant/wetting agent
2 Magnesium stearate Hydrophobicity enhancer
3 Stearic acid Surfactant/plasticizer
4 Stearamide Plasticizer
5 Lecithin Surfactnat/plasticizer
6,7,8 Guar gum, Pectin & Xanthan gum Extender
9 Starch Filler
10 Polyethylene glycol (400, 1000, 3350) Plasticizer
11 Polypropylene glycol Plasticizer
12 Triethyl citrate Plasticizer
13 Glycerol monostearate Plasticizer
14 Sodium lauryl sulphate Surfactant
15 Polysorbate 80 Surfactant
16 Talc Filler
17 Titanium dioxide Colorant/Filler
18 Microcrystalline cellulose Filler/Extender
19 Trehalose Extender/Filler
20 Glycerol Plasticizer
21 Erythritol Plasticizer
22 Calcium carbonate Filler


A series of formulations was then developed using the above-listed compounds in accordance with the standard coating formulae, also listed above. Cast films were made from dispersions prepared using aqueous media of the different formulations and evaluated for various features to determine which products presented the best chances of being used as coatings. The tests ranged from tensile tests, moisture uptake/desorption, water vapour transmission rates, colour consistency and tackiness. Only films judged as acceptable/meeting set criteria were selected for further evaluation/development.

Tablet coating trials

Coating trials were undertaken in a laboratory scale Aeromatic Fielder fluid bed coater. Conditions of the test varied depending on the coating under consideration. The aim, however, was to obtain a standardized weight gain of 3-4% for each product, so the conditions were continuously adjusted to meet this criteria. Study tablet cores were made with Diltiazem hydrochloride (30%) and lactose and were compressed to achieve a fill weight of 200mg. Other materials added included magnesium stearate (0.5%); microcrystalline cellulose (15%), pregelatinized starch (15%) and aerosol (0.1%). Cores which were successfully coated were subsequently evaluated for drug release properties (in addition to the usual pharmacopoeial QC tests) which for brevity are not shown.

Dissolution (drug release) testing

Automated dissolution test were performed on diltiazem HCl tablets (30mg) due to its high solubility. All tablets coated to levels as for stability samples and test undertaken in HCl (pH 1.6); Na-acetate/ Acetic acid buffer system (pH 4.5) & phosphate buffer (pH 6.8).

Stability studies

To test for stability, three formulations of moisture sensitive drug substances (APIs) were prepared as follows: All quantities shown are %.

Aspirin Enalapril maleate Niacinamide
API 30 5.0 50
Lactose 38.9 63.9 18.9
Stearic acid 1 1 1
Microcrystalline cellulose 15 15 15
Pregelatinized starch 15 15 15
Aerosil 0.1 0.1 0.1
Fill weight 250mg 100mg 500mg


Once prepared, cores were coated with experimental and commercially-available formulations and placed on stability for periods ranging from 3months to 12 months. Conditions were standard USP stability conditions (40C/75% RH) either in a stability chamber or a desiccator containing sodium chloride slurry as the humidity provider.

Samples were removed at regular times (2 weeks, 1 months, 3 months, 6 months, 9 months and 12 months and tested for the amount of drug left after decomposition. The assay methodology was as follows:

Aspirin: RP HPLC using acetonitrile 25%/DI H2O 75% mobile phase. Acidified with 1% orthophosphoric acid (85% w/w). Elution: 1.0ml/min (Isocratic), Column temperature ambient and detection wavelength of 287nm. Both peaks for aspirin and salicylic well resolved.

Enalapril: RP HPLC using acetonitrile 25%/phosphate buffer 75% mobile phase. Buffer prepared from sodium dihydrogen phosphate (NaH2PO4) 10mM (adjusted to pH 2.2 with orthophosphoric acid 85% w/w). Elution: 1.5ml/min (Isocratic), Column temperature of 60C and detection wavelength of 215nm. All peaks well resolved.

Niacinamide: Two methods used: USP assay by simple UV at 450nm and RP HPLC (c18 column) using methanol 15%/DI H2O as mobile phase (+ 0.005M heaptanesulfonic acid and 0.5M triethylamine). Elution: 2.0ml/min (Isocratic), Column temperature of ambient and detection wavelength of 280nm. Peaks well resolved.


The results shown below are for the most promising formulation out of 4 candidates developed so far. This specific prototype was prepared using the following formula:

Purpose %
Aminomethacylate copolymer Base polymer With held
Pectin Extender/adherent With held
Stearamide or cholesterol Surfactant/plasticizer With held
Talc Filler With held
Polaxamer F127 Surfactant With held



As shown below, there are differences in dissolution profiles depending on the medium being used. It must be emphasized, though, that except those samples coated with Eudragit EPO commercial product, all samples were fast dissolving (90-100% release within 15min).

In HCl, all the five samples dissolve extremely rapidly and in accordance with the requirements for immediate release coated tablets, achieve 100% release well before the mandatory 45 minutes stipulated.

In pH 4.5 acetate buffer, again all the samples were able to achieve 100% release well-within the mandated time. These results were all as expected.

In pH 6.8 phosphate buffer, all the samples with the exception of the Eudragit EPO commercial formulation dissolved rapidly, including the novel formulation which is based on Eudragit EPO. This shows that drug release properties are enhanced with the novel product compared with the commercial formulation.

Stability studies

 Aspirin tablets (75mg)

Following accelerated stability study conditions of 40C/75% RH open dish in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) the 12-month results (aggregated) are shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

The results show that aspirin samples coated with the commercial formulations significantly decrease in strength over time period of study while the novel formulation is not affected as much as the uncoated samples. This shows that the novel formula does not accumulate moisture within the coating as much as the commercial products so as to cause degradation.

Enalapril Tablets (5mg)

 As in previous case, accelerated stability study conditions of 40C/75% RH open dish placed in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) for a total 365 days were used. 12-month results (aggregated) are shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

As in aspirin’s case, results for Enalapril also show that samples coated with the commercial formulations significantly decrease in strength over time period of study. Those coated with the novel formulation are not significantly affected and retain their viability to the same extent as the uncoated samples. This shows that the novel formula does not accumulate moisture within the coating as much as the commercial products so as to cause degradation.

Niacinamide Tablets (250mg)

The study conditions were also replicated for Niacinamide and were: 40C/75% RH open dish placed in sealed/conditioned Sanyo MCO stability chamber (UCLan) or desiccator (validated for RH) in temperature-controlled oven (SOP) for a total 365 days. 12-month results (aggregated) are also shown below:

Key to the graph: NV – Novel formula; ED – Eudragit EPO; OP – Opadry AMB; SP – Sepifilm LP & CT – Uncoated tablets.

It can be seen that this time, a mixed picture is obtained, with the uncoated and Sepifilm coated samples showing more degradation than samples coated with Opadry, Eudragit EPO and the Novel formula. On further investigation, it was found that the release of nicotinic acid exacerbated degradation of the remaining niacinamide within the tablets, hence the pictur shown does not necessarily represent the impact of the coatings.


The results show a concept that could be the basis for a unique pharmaceutical coating system. The concept is desirable for the following reasons:

1)         Innovative, scientifically validated approach for elaborating pharmaceutical polymer coatings of superior functionality with a strong scope for IP.

2)        Simplicity and wide applicability of the approach which keeps the risk of the technology not being adopted by customers low but keeping the marketability to potential purchasers high.

3)         Timing and flexibility of the technology in response to environmental and technological concerns regarding the use of solvents in pharmaceuticals.

The results demonstrate proof of principle, even though more work is required to assess scalability.


  1. R.I. Mahato, and A. S. Narang. Pharmaceutical Dosage Forms and Drug Delivery. Routledge, Boca Raton, Fl. pp: 313-335. 2012
  2. Overview of Tablet Coatings –
  3. J. E. Hogan. Film Coating Materials and their Properties. in: G. Cole, J. E. Hogan and M. Aulton. Pharmaceutical Coating Technology. Routledge, Boca Raton, Fl. pp 6-50.
  4. Tablet Film Coatings Market
  5. IMS Health (IQVIA) Internal communication

Excipient Selection Trends – A Review of US FDA Novel Drug Approvals Data

In this article, we summarise data obtained from examining label declarations about excipients used in both ‘small molecules’ and biological/protein products approved by the FDA between 2007 to 2009 and 2017 to 2019. The aim is to identify any trends in the way excipients use has changed over this time period.

Dr. Enosh Mwesigwa | Contributing Writer


Excipients play a key role in the drug product development process, facilitating the formulation of stable dosage forms while also aiding their administration. The criteria for selecting excipients, their concentration, grade, and functionality evolves along with developments in biopharmaceutical sciences, regulatory landscape as well as wider societal demands.

New drug approvals between 2007 – 2009, and 2017 – 2019

Table 1 lists the number of new drug application approvals segmented by molecule type. The data is publicly available on the FDA portal. Generic product approvals were excluded.

Table 1: New drug approvals by molecule type for the period between 2007 – 2009 and 2017 – 2019

2007 2008 2009 2017 2018 2019*
Small molecules 16 18 20 32 36 7
Biological molecules 2 4 6 14 22 5
Other 1 2 0 0 1 0
Total 19 24 26 46 59 12

*2019 data only up to June 2019

For the period between 2007 and 2009, the US FDA approved a total of 69 new drug applications. The majority of approvals were ‘small’ chemical entities (78.3%). Biologicals accounted for less than one fifth (i.e 17.4%). The rest of the approvals (such as contrast media agents and inorganic substances) accounted for 4.3%. Fast forward a decade on, the number of approvals is 75 but importantly, the contribution of different categories much different. Thus, while ‘small’ chemical entities still account for the bulk of approvals at 64.1%, the proportion of biologicals approved has doubled, accounting for 35% (roughly 1 in 3), pointing to the increasing importance of biotechnologically-derived medicines.

New drug approvals by dosage form

Table 2 is a breakdown of new drug application approvals by dosage form for the period between 2007 – 2009 and 2017 and 2019.

Table 2: New drug approvals by dosage form for the period between 2007 – 2009, and 2017 – 2019

2007 2008 2009 2017 2018 2019
Tablets (Total)

FC Tablets

Non-FC Tablets

Matrix Tablets

Other Tablets































Hard Capsules

Soft Capsules













Other oral solutions, powders & liquids 1 1 0 2 2 0
IV, SC, IM Injections 6 17 8 18 23 6
Patches, Creams, Lotions, etc 1 2 1 0 0
Opthalmic Drops 0 1 0 2 1 0
MDIs, DPIs, Nebulisers 0 1 0 0 1 0
Others 0 0 0 0 1 0

Oral route still ahead, but only just

The oral route (tablets, capsules and other oral formats) accounts for just over a half of all approvals (54% during 2017 – 2019 vs 53.3% for 2007 – 2009). This is a remarkable drop from historical levels, where the oral route was the main route of drug administration, accounting for over 75% of all marketed products1. With the increasing contribution of biotechnology to new drug discovery, the vast majority of which are delivery parenterally, it is understandable why the proportion of new drugs delivered orally has decreased.

Table 3 Frequency of dosage forms manufactured in the UK (historical data)1

Tablets 45.8
Hard & Soft capsules


Oral Solutions, Suspensions, etc 16.0
IV, SC & IM Injections 15.0
Topical (Patches, Creams, Lotions, etc) 3.0
Opthalmic solutions 1.8
MDIs, DPIs, Nebulisers 1.2
Suppositories, pessaries, etc 3.6

And the rest?

The data shows the inhalation, ophthalmic and topical routes are as less used today as they were a decade ago, accounting for 6.5% during the 2007 – 2009 approvals versus 5.3% for 2017 – 2019 approvals. These formats have tended to be used for very specific therapeutic objectives, and new drugs developed this way are far in between.

Excipient distribution in new drug approvals

Table 4 ranks different excipients by order of appearance in manufacturer-declared labels for those products intended to be administered orally.

Table 4: Excipients in new drug approvals (between 2007-2009, and 2017 – 2019)

2007 – 2009 2017 – 2019
Microcrystalline cellulose (all grades) 21 42
Magnesium stearate 24 42
Functional & Aesthetic Coatings (Total) 18 29
PVA film coatings 6 15
Hypromellose film coatings 11 13
Methacrylic co-polymers (Enteric) 1 1
Other coatings systems 0 0
Croscarmellose sodium 13 24
Colloidal Silicon dioxide 13 23
Lactose (all grades) 17 20
Mannitol 10 17
Povidone (all grades) 8 14
Hypromellose – for tablet cores 14 11
Sodium starch glycolate 6 9
Crospovidone 8 8
Sodium stearyl fumarate 2 8
Copovidone 1 4
Sorbitol 0 4
Native & modified corn starch 5 4
Carboxymethyl cellulose sodium 0 4
Flavours (all types) 1 4
Hypromellose acetate succinate 1 4
Sweeteners (Sucralose & Aspartame) 1 3
Calcium phosphate (all grades) 4 2
Hydroxypropylcellulose (all grades) 5 2
Xanthan gum, Carageenan and other gums 0 1
Sodium bicarbonate 0 1
Methacrylic co-polymers (Matrix) 0 1
Polyethylene glycol (solid grades) 1 0
Ethylcellulose 0 1
Polyethylene oxide 0 1


Fillers and diluents

Diluents/fillers are included in solid dosage forms as a way to increase weight and improve content uniformity. Many materials have been used as diluents, including starches and its derivatives, lactose, sugar alcohols such as sorbitol, xylitol and mannitol, as well as several inorganic salts.

Data shows that a decade ago (i.e 2007-2009), microcrystalline cellulose was the most widely used filler/diluent, appearing in 51.2% of all oral products approved by the FDA. A decade on, it remains just as popular, appearing in a remarkable 68.8% of approvals. It’s multifunctional properties (filling, binding, lubricity, minimal bulk density and cost-effectiveness) put it in good stead among formulators and manufacturers, so it is no surprise how popular it is.

Lactose, which by virtue of its excellent compressibility, cost advantages and availability was one of the most commonly used filler/diluent a while back has, however, decreased in usage (from 41.5% usage to 32.8% over the period of study) while ‘newer’ materials such as mannitol are seeing a resurgence (from 24.4% to 32.8%). It is difficult to figure out the reasons for this decrease in usage but it could well be due to anxieties around lactose tolerance, perceived animal origin risks, etc.

Inorganic fillers, such as calcium hydrogen phosphate, offer different functionality to organic materials and have had their merits (density, flowability, compressibility, chemical stability, etc). Yet their usage consistently remains low among new approvals over the study period.

Tablet coatings

The data also shows that manufacturers have embraced tablet film coating technologies over the last 10 years. For example, between 2007 – 2009, 61.1% of all approved tablet were film coated tablets, which rose to 69.5% during the 2017-2019 period. A decade ago, only about 50% of new tablet approvals were film coated. Hypromellose-based coatings were the most widely used systems at 30.6% while polyvinyl alcohol-based systems accounted for only 16.7%. Today, the usage of tablet film coatings has grown to 63% as manufacturers increasingly appreciate the performance advantages of coating dosage forms. Interestingly, the popularity of polyvinyl alcohol-based systems has grown to 32.8% while that of hyromellose systems have dropped slightly to 27.9%.


Binders are some of the most essential ingredients in a formulation. Their purpose is to hold the active pharmaceutical ingredient and inactive ingredients together in a cohesive mix. The data shows that povidone and copovidone are the most popular binders today, appearing in 30% of all solid dosage approvals. Usage of hypromellose has decreased over the years, dropping from 34% a decade ago to 18% today. Starch (both native and pregelatinised has also decreased from 12.2% to 6.6%. Further details are shown below:

Disintegratants and superdisintegrants

Disintegrants and superdisintegrants are used in oral solid dosage forms to cause a rapid break-up of solids as a first step to dissolution. Traditionally, the most commonly used agents included crospovidone, croscarmellose sodium, starch and sodium starch glycolate. The data shows that superdisintegrants are the most preferred materials, with croscarmellose sodium being the most popular disintegrant (appearing in just under 40% of the 2017-2019 approvals vs 31.7% during 2007-2009 approvals). The second most popular disintegrant is sodium starch glycolate (used in approx. 15% of approvals) while crospovidone is the third-most popular agent, representing 13% approvals (compared with 20% a decade earlier). Low subsitituted HPC and starch were the least used disintegrants.

Lubricants and glidants

Lubricants are materials added in small quantities to tablet and capsule formulations to improve to decrease friction at the interface between a tablet’s surface and the die wall during ejection and reduce wear on punches & dies. Lubricants also prevent sticking to punch faces and in the case of capsules, sticking to machine dosators and tamping pins. Glidants, on the other hand, enhance flowability by reducing particle-particle interactions.

Of all the lubricants available for use, magnesium stearate is by far the most widely used lubricant, appearing in 74% of new approvals in 2017-2019 (versus 61.5% in 2007-2009). It is also often the cause of a number of problems experienced in solid oral dosage manufacturing, including slowing down dissolution. As a result, newer lubricants have been introduced, such as sodium stearyl fumarate. However, its usage remains low (at 14% in 2017-2019 approvals).

When it comes to glidants, colloidal silica is the most popular glidant, being present in between 33 and 40% approvals across the years of study. Other materials, such as talc and glyceryl monostearate did appear to have fallen out of favour and are apparently absent in the studied products.

Other dosage forms

Table 5 shows a list of excipients used in the rest of product formats, i.e parenteral, topical, inhalation and oral solutions.

Table 5: Excipients used in parenteral, topical, inhalation and oral solutions dosage forms

2007 – 2009 2017 – 2019
Polysorbate 80 9 21
Sodium chloride 7 8
Sodium phosphate (all grades) 6 8
Sodium lauryl sulphate 5 2
Polyethylene glycol 400 6 7
Cyclodextrins 1 0
Albumin 0 1
Poloxamer 188 1 1
Sucrose 4 9
Tromethane 1 2
Trehalose 0 3
Petrolatum 2 0
Tocopherol 4 0
Polydimethoxysilane 2 0
Lipid excipients (all) 1 7
Carbomers 0 10
Preservatives (all) 2 6
Potassium sorbate 0 1
Benzalkonium chloride 2 1
Benzoic acid 0 1
Phenol 0 2
Parabens 0 1
Citric acid 11
Sodium citrate 11

Parenteral products

Parenteral products can be solutions, suspensions, emulsions for injection or infusion, powders for reconstitution before injection or infusion, and implants for placement into the body. When a solution is required, water for injection can be used and for less soluble actives, a co-solvent or surfactant can be utilised. In some instances, solubility enhancers such as cyclodextrins are used. A range of vegetable oils can also be used either as emulsions or to create non-aqueous solutions.

pH is one of the critical considerations when formulating parenteral products. Buffers are therefore routinely used to achieve a desired pH, which can be close to physiological pH where desired, or for the case of peptide and protein drugs, a pH that ensures stability. With the exception of Polysorbate 80, which we found routinely used in the vast majority of parenteral products (44.7% during 2017-2019 and 29.0% during 2007-2009), there was no consistency among other excipients. The buffers in use included sodium acetae – glacial acetic acid, sodium phosphate dibasic and sodium dihydrogen phosphate, tromethane, l-histidine, and glycine.

Finally, a key consideration for biological drugs, and protein molecules in particular, is the requirement for stabilization. A number of excipients are added, not only during manufacture, but also in the final formulation, to retard degradation or prevent aggregation. The six main types of materials used include buffers, salts, amino acids, polyols, disaccharides, surfactants, and antioxidants. Trehalose, sucrose and albumin were the only materials we found to be in use as stabilisers during the study period.

Inhalation, Ophthalmic and Topical Products

The final group of dosage forms to consider are inhalation (metered dose inhalers, dry powder inhalers or nebulisers), ophthalmic solutions and topical products. As the data above in table 5 shows, the number of approvals in this sub-category were comparatively few, and correspondingly, the number of excipients used.

Among the excipients of interest are preservatives – typically used in ophthalmic and topical products to limit the growth of bacteria. Within approvals, different products used different materials, including phenol, parabens, potassium sorbate, benzyl alcohol and benzalkonium chloride, with no single agent being a clear dominating material.

Concluding remarks

Excipient selection is guided by many factors, including limiting characteristics of the active ingredient, such as dose, stability, compactability, and solubility, and others such as functionality, supply availability, compatibility with the active ingredients, individual company policies as well as formulators’ familiarity with a given material.

In the 1980s and early 1990s, excipient functionality was a big deal- product developers selected excipients with quantifiable physicochemical properties. In the late 1990s and early 2000s, focus shifted to excipients that aided the optimization of API bioavailability. Later on, the rise in senior citizen population and the recognition of paediatric consumers brought to light the need for technologies that could aid ease of administration and or palatability. More recently, society’s quest for sustainability, health and wellbeing has had a noticeable uptick in the use of materials that draw upon these themes.

A period of twelve years is not long enough to allow us to draw concrete conclusions, and above all, from a limited data set that we’ve selected for analysis. Yet, there are some noteworthy changes, not least the increase in the number of biological drugs vis-à-vis ‘small’ molecules. It is not very long ago when oral dosage forms represented the bulk of approved drugs – sometimes as high as 80%. In the last decade, biotechnology has created entirely new classes of therapeutic molecules, including monoclonal antibodies, cancer vaccines, gene therapy, antisense strands, enzymes, and proteins, leading to a rapid increase in the number of parenteral drugs, which are now accounting for up to 50% of approved drugs. This will have important implications to the traditional excipient landscape, going forward.


  1. AULTON, M. E., & TAYLOR, K. (2018). Aulton’s pharmaceutics: the design and manufacture of medicines. Edinburgh, Churchill Livingstone/Elsevier.
  2. United States Food & Drug Administration. Inactive Ingredient Search for Approved Drug Products.
  3. Hamman J, Steenekamp J. Excipients with specialized functions for effective drug delivery. Expert Opin Drug Deliv. 2012 Feb;9(2):219-30. doi: 10.1517/17425247.2012.647907. Epub 2011 Dec 23. PMID: 22196483.

6 Simple Tips for Compelling Scientific Presentations in 2022

Eric Monlin | Public Speaking Coach & Founder, Public Speaking Inc., New York

The twenty-first century is a century of ideas, and ideas, when effectively packaged and delivered, are changing the world. Some people are exceptionally good at presenting their ideas. They have the skill that elevates them and gives them influence over their peers and society. As scientists, we all have ideas and passions, and yearn to inspire others. So, wouldn’t be amazing if we can identify the exact techniques used by the world’s greatest communicators, and apply their secrets to wow our audiences? In this article, I provide insights, based on personal research of hundreds of TED presentations, direct interviews with speakers and personal experience from years of coaching ordinary leaders and speakers over a 20 year period, to help you speak with confidence and authority, whether it is delivering presentation at your company, or a major scientific conference.

The anatomy of great presentations

In 2012, civil rights lawyer Bryan Stevenson gave a talk to an audience of 1,000 people in California. He received a standing ovation and his TED talk has been viewed online over one-and-half million times. For around twenty minutes, Stevenson captivated his audience by appealing to their heads and hearts. At the end of the talk, the attendees donated a total of $1 million to his charity, The Equal Justice Initiative. That’s equivalent to $50,000 for each minute he spoke!

What is remarkable is that Mr. Stevenson did not use any Power Point, visuals or props. It was only through the power of his narrative that carried the moment. I am sure you have viewed other riveting presentations. Some of these were probably backed by engaging slides and graphics. What is clear that there are many ways to share ideas. Some speakers tell stories, and others provide rich data. Great speakers are entertaining, captivating and inspiring; they understand the science and art of persuasion.

The late Steve Jobs, Apple cofounder and technology visionary is famous for his presentation skills. His iPhone launches and commencement speech at Stanford University in 2005 show his ability to captivate audiences. It is little wonder that CEOs everywhere have now adopted Steve Jobs methodology.

Dale Carnegie – The Art of Public Speaking

A key starting point for students of public speaking is Dale Carnegie self-help book, The Art of Public Speaking, first published in 1915. Dale Carnegies recommended that speakers keep their talks short. He said stories where powerful ways of connecting emotionally with audiences, and suggested the use of rhetorical tools such as metaphors and analogies. He understood the role of enthusiasm, practice, and strong delivery to touch people.

Now, while everything Carnegie recommended over 100 years ago remains true today and is the foundation of effective communication today, he did not have the tool we have today. Today’s speakers have Power Point, video and the internet.

We’re all Salespeople

It also is the case that the most effective speakers have understood the knack of getting their ideas to stand out in a sea of noise. Effective salespeople are good at inspiring potential buyers. This is the same blueprint if you want to be an effective speaker. You need to learn how to sell yourself and your ideas more persuasively. If you can’t inspire anyone else with your ideas, it doesn’t matter how great your technology is – there will be no takers!

What makes a presentation compelling?

All great and inspiring talks have three components:

  • Emotion-they touch hearts
  • Novelty-they reveal something new
  • Memorable-they present content in ways people never forget


Great communicators reach heads and touch hearts. The problem with the majority of us (especially within the sciences) is that we forget the ‘heart’ bit. We therefore need to learn how to identify our passions and use them in our stories, thereby creating deeper connections with audiences.


Novelty is one of the most effective way to capture a person’s attention. Humans, it seems, are hardwired to give attention to new things. Research released by YouTube Trends has shown that content that is truly unique and unexpected gets noticed on the platform. Thus, a key aspect of effective communication is engaging audiences is to give them new perspectives, the wow moments.


What’s the point of sharing great ideas if nobody remembers what you spoke about the moment you hand over the microphone? Research shows that to be memorable, a presentation has to be of an ideal length of time, and has to create vivid, multisensory experiences that allow the audience to recall the information successfully.

Here are 6 tips to effective presentations

Better than average communicators are generally more successful than most people, but great communicators are the ones that start movements. They are remembered long after their speeches. Think Jefferson, Churchill, Gandhi, Kennedy, King, Mandela and Obama, to name but a few.

Failure to communicate effectively in science can means research won’t get funded, products won’t get sold, projects won’t get backing, and careers won’t thrive. As career scientists, your ability to deliver captivating talks can mean the difference between acclaim and toiling in obscurity.

So here are my six simple tips you can adopt in 2022 to move your presentations to a new level, enabling you to communicate in ways that are passionate, powerful, and inspiring.

Tip #1: Unleash the Master Within

Thomas Jefferson, the third President and Founding Father of the United States of America is highly regarded even today as one of America’s most influential leaders. He was a passionate believer in democracy and considered it essential to the expression of society. He promoted national self-determination, public education, and a free press.

As the principal author of the United States Declaration of Independence, he wrote many inspiring speeches, which went on to shape the course of history. The preamble to the Declaration of Independence, for example, evokes the original spirit of the American nation:

‘We hold these truths to be self-evident, that all men are created equal, that they are endowed, by their Creator, with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness….’

Passion and public speaking are intimately linked. To touch your audience, you need to dig deep to identify how you’re uniquely and meaningfully connected to your presentation topic. This is where you’re operating at people’s emotional level. Passion is your why, or inspiration. It is not a passing interest or a hobby but rather that thing that’s core to what makes you, you! It is what gives you the authority, mastery and command, and your presentation will be empty without it.

Bear in mind that in some situations, what fires you up might not be obvious. Often, it is dressed up as something else. Howard Schultz, the former Chairman and Executive of Starbucks once said his passion was not coffee, but rather creating a third place between work and home! Coffee was only the by-product.

Passion is what makes successful speakers always enthusiastic about sharing their ideas. They have bags of charisma. They radiate joy and positivity about their ideas, and they are motivated by ‘good’ intentions, such as a desire to make a difference, create impact or leave a legacy.

Just as we know that happiness at and passion about the work are vital to career success, it is the same with public speaking. If you’re not having a great time in your job, how do you expect to generate enthusiasm in your presentation about it?

So while we can talk about effective storytelling, designing beautiful PowerPoint slides or how to use body language more effectively in your public speaking but the fact, and it is a fundamental fact, that effective presentations require passion first. Effective stories, slides or body language mean little if the speaker does not radiate passion and enthusiasm about what they’re communicating.

Tip #2: Master the Art of Storytelling

In this information-saturated age that we live, you won’t be won’t be heard unless you tell compelling stories. Facts and figures, and all the rational things that we think are important in science actually don’t stick in our minds that well. However, stories create “sticky” memories by attaching emotions to things that happen.

Stories also affirm who we are. We all want affirmations that our lives have meaning. And nothing does a greater affirmation than when we connect through stories.

This is why people who know how to weave stories about their work and share good stories have a powerful advantage over others.

But what constitutes a good story? Consider the case of major film studios, such as MGM, Pixar and Disney. They have individually mastered the ability to move audiences deeply, causing adults to tear up next to children, while persuasively transporting us into make-believe worlds.

Their perennial success in the business of movies is down to the way they choose ideas, create compelling characters, invoke empathy, drama and conflict, create villains and heroes, and the endings (the moral), that is, storytelling. It is the same with great speakers.

Aristotle, the Greek philosopher, believed that persuasion happened when three components were represented: ethos, logos, and pathos. Ethos is credibility. We tend to trust and agree with people we respect for their achievements, titles, experiences, etc. Logos is about persuasion through logic and data. Pathos is the act of appealing to emotions.

You can see this approach in Stevenson’s TED talk. For instance, he started with his personal experiences. The first five minutes (30 percent of the presentation) were on his personal stories and experiences. Data about incarceration in U.S. prisons came in later to support his ideas. He chose his approach to make it easy for the audience to connect with him on a personal and emotional level.

Studies have shown that inspiring communicators use three types of story.

The first types of story are personal stories about who we are. They should be descriptive and rich with imagery to enable the listener to imagine themselves with you at the same time. Delivered well, a captivating story makes your audience know something about you, which builds trust. Granted, personal stories are a sensitive subject, but if you choose them carefully, nothing comes close to grabbing the audience’s attention early on. A personal experience that produced an unexpected outcome often works well. The key thing is not to make them show how great you are, etc.

The second types of story are stories about other people who have learned a lesson the audience can relate to. The power of such stories is that they shed light on our shared humanity. So while personal stories can evoke empathy, it is stories about other people that audiences mostly empathise with. Empathy is the capacity to recognise and feel others’ experiences.

The third type of story are stories about successes or failures of products or brands. Harvard Business School is famed for the Case Method to teaching MBA students. These cases usually tell stories (real or simulated) about challenges faced by business executives and lessons that can be learnt from their experiences. This way, students are able to relate to business theorems with particular challenges.

Just as a great novel or movie goes about storytelling, a great presentation has to have a narrative, a cast of characters (hero and villain) and the moral of the story. The story should reveal a challenge (villain) being faced, a protagonist or hero (your solution) who is committed to rising to the challenge, the townspeople (customers) to be freed by the villain, and the outcome (the people who will be freed and live happily ever after their struggles are ended).

Tip 3: Have a Conversation

Great speakers deliver their content in a natural, authentic way, akin to having a comfortable conversation with a friend. It is a skill learned through practice and is not something that can just be memorised and perfected in an instant.

Think of the times you had a genuine conversation with a friend. Hopefully, you’re typically operating in a zone of emotional rapport. You were able to persuade your friend because you had gained their trust, and your voice, gestures, and body language were all in sync with your words.

This authenticity does not happen spontaneously. It is something that is learned, through practice. It takes hours of practice, searching for the right words that best represent the way you feel, delivering those words in a powerful way for maximum impact.

Good verbal delivery is based on what is called in the military as ‘commanding presence’. Commanding encompasses the following key elements:

  • Rate: the speed at which you speak
  • Volume: the loudness or softness
  • Pitch: high or low inflections
  • Pauses: short pauses to put emphasis on key words
  • Gestures, facial expressions, and body language

Great communicators speak at the right rate (the ideal rate of speech is between 180 and 200 words per minute), they speak concisely and precisely, and their voices project across the entire room because they speak from their diaphragms. They compliment the words with the gestures and facial expressions, to make a strong argument even stronger.

Tip 4: Reveal Something New

Great speakers incorporate new information or perspectives that are completely new to their audiences. The information may be packaged differently or presented in a way to solve an old problem. Revealing new perspectives works because our human brains love novelty. Unfamiliar, unexpected or unusual outcomes in a presentation audience, jolts them out of their preconceived notions, and provides them with new perspectives.

One of the most captivating public speakers on the web today is Professor Hans Rosling. He often talks about population, economic development and global health issues. As well as delivering data in a fascinating and easy-to-digest way, he is able to reveal completely new perspectives.

This is the same approach taken by all successful communicators. They opt to deliver content in ways that reveal something that is entirely new; things the audience was not familiar with.

Seth Godin, the popular blogger and author, has made a career out of delivering ideas differently. He told a TED audience in 2003 that in a society with information overload, the natural instinct is for audiences to ignore most of it. Thus, delivering the same old, tired content using the same boring methods as everyone else is bound to fail. Adding a little spin to content allows the audience to be more receptive to the message.

Tip #5: Incorporate Jaw Dropping Moments

A jaw-dropping moment in a presentation is when the speaker delivers a shocking, impressive or surprising moment that is very moving and memorable that it grabs the audience’s attention, and is remembered long after the presentation is over. Jaw-dropping moments are capable of heightening emotions, helping listeners recall and act on the message.

In 2009, Bill Gates, the founder of Microsoft delivered a talk at a technology conference about malaria. While on stage, he opened up a glass jar and said, “Malaria is spread by mosquitoes. I brought some here, just so you could experience this. We’ll let those roam around the auditorium little bit. There’s no reason only poor people should have the experience.” The audience roared with laughter, cheered, and applauded. Bill Gates had effectively delivered his jaw-dropping moment.

A few sentences earlier, Bill gates had talked about how many children lives’ could be saved through better medicines and vaccines. He was able to deliver an emphatic talk. He used shock and humour to drive his point home.

Journalists call the mosquito gimmick “the hook.” It’s the wow moment, the showstopper and the device used to capture the audience’s attention. Used cleverly, it allows listeners to share your story. So, before creating a Power Point presentation, take time to think about the story first. In the same manner a movie director storyboards the scenes before shooting, you should create the story before opening the tool. Aim to tap into al the senses – seeing, touching, feeling, and smelling.

Things that shock, surprise, bring fear, joy or wonder impact how vividly we remember them. It is the reason many of us remember our first kiss, the birth of a child, winning an award, break-ups or death of a loved one. It is as though these emotionally charged events are burned into our memories. Therefore, if you want to connect with an audience in an emotional level, you will need to present information that is vivid, using tools and examples that meaningful and concrete.

Tip #6: Be mindful of Cognitive Backlog

Most memorable presentations are noted for three key elements:

  • Are concise and organised systematically
  • Use multisensory approaches to paint mental pictures in their audiences
  • Are authentic, open and transparent.

Conciseness and Organisation

It is an undeniable fact that listening is mentally draining. Thinking, speaking and listening are physically exhausting. Think of the last time you sat through a one-hour lecture or power Point presentation. Too much information prevents the effective transfer of ideas, leaves the audience anxious and even frustrated. Researchers refer to this information overload as “cognitive backlog,” which is akin to piling on weights, which makes the mental load heavier.

This is the reason all TED talks are required to be no more than 20 minutes. TED believes that 20 minutes is short enough to hold one’s attention, and long enough to cover anything relevant.

If you must give longer presentations, it is necessary to split them into chunks, for instance, by adding breaks, videos, stories or demonstrations, every 10 minutes. The longer the presentation, the more the listener has to work to organise, comprehend and recall information.

John F Kennedy, the 35th president of the United States, gave a famous speech at Rice University in late 1962. It was here that Kennedy outlined his vision for America to explore the moon. The speech, which lasted just over 17 minutes, captured the nation’s imagination about the importance of exploring space.

But it is not enough to be concise. In fact conciseness means nothing if the information is haphazard and unstructured. This is why some influential communications professionals talk of the rule of threes. This rule simply means that people remember three pieces of information well. Add more items and retention starts to wane quickly.

To make use of the rule of three, structure your story in three key chunks or messages around a central theme. It turns out that the rule of three pervades our work and social lives on a daily basis. You will find it in literature (the three little pigs and, the three musketeers), in the arts (three primary colours), politics (the three arms of government), etcetera. If it works for the world’s greatest writers and painters, it will work for presentations, too.

Use of Multisensory Experiences to Paint Mental Pictures

Think again about a particularly boring talk you had the misfortune of attending. What made it boring? What was your level of engagement? Chances are that it had too much text, lacked structure, was visually unappealing and the content was unengaging.

The fact is that boring does not wash well with the human brain. The brain craves multisensory experiences and will quickly switch off when it is exposed to stuff that is boring. Having presentations that include more than one sense: sight, sound, touch, and smell are difficult to ignore. This is why great talks use mesmerizing images, captivating videos, intriguing props, beautiful words, and more than one voice to bring the story to life.

Granted, some of these experiences, such as smell and taste, are difficult to incorporate in presentations. The key thing is to build a presentation around one or two main senses, and incorporate one other. The harder experiences can be simply described.

Slides should incorporate images and videos rather than text whenever possible. The audience is far more likely to recall information when it is presented in a combination of pictures and text rather than text alone.

The other important sense to use is sound. The auditory sensation is very powerful and how the content is delivered (pitch, rate, volume, intensity, sound effects) can all touch the listeners soul.

The final sensation to use is feeling. Feeling has been described as the “holy grail” of presentations owing to its ability to transport audiences to another place. The visual display of information helps the audience to see it while touching allows them to complete the journey.

Being Authentic, Open and Transparent

Although public speaking is an artform, it is not act one can put on. Am sure you have met a person who acts and speaks one way in private only to sound completely different when delivering a presentation. Such people act, look and sound like two different people. They lack authenticity, openness and transparency. Unfortunately, audiences are not thick – they can see through a fib, so trying to be somebody you’re not is a sure way to fail at building rapport with your audience.

If your goal is to inspire the audience and take them with you, you must be real. Here are some things to do:

  1. Use your own voice – there’s no need to sound ‘posh’ or adopt some ‘esoteric voice.’ Chances are that it will make it difficult for your audience to keep up.
  2. Disregard the fact this is a presentation. Instead, regard it as a conversation, the kind you typically have with family and friends.
  3. Relax! This is not a sermon on the mountain, rather you’re just sharing your knowledge and expertise for people to take as much, or as little, as they wish.
  4. Be yourself – you’re fantastic at it!

Finally, try to recapture your inner 3-year old-the times you were carefree, and had no hang ups. If you can get back to that, you’ll be an impactful public speaker.

2021 saw the successful introduction of COVID-19 Vaccines. Here’s what we learned

Although vaccines have proven to be effective, more is needed if we’re to end the pandemic

Following the approval of Pfizer’s COVID-19 vaccine, we started 2021 full of hope. With vaccines in the supply-chain, the idea was to get shots in people’s arms as quickly as possible, curb the pandemic and get life back to normal. That was the plan then.

12 months on, roughly 9 billion doses have been administered. In the United States, three vaccines—Pfizer-BioNTech, Moderna and Johnson & Johnson — are widely available. Elsewhere, about two dozen other vaccines have also been approved. In many higher-income countries, booster shots have already started to be administered.

But 2021 also gave us a wealth of knowledge about vaccines’ capabilities. With the emergence of aggressive unpredictable variants, inequitable distribution, hesitancy, and the natural course of waning effectiveness, we now know there still remains much work to do to bring this pandemic to an end. As if to hammer home the point, the detection of the Omicron variant in late November brought home the uncertainty of the pandemic’s trajectory.

So here are some of the key lessons we’ve learned in 2021 about COVID-19 vaccines.

COVID-19 vaccines work, even against emerging variants

Many COVID-19 vaccines proved effective over the last year, particularly at preventing severe disease and death. That’s true even with the emergence of more transmissible coronavirus variants.

In January, during a bleak winter surge that saw average daily cases in the United States peak at nearly a quarter a million, the vaccination rollout here began in earnest. Soon after, case numbers began a steep decline.

Over the summer, though, more reports of coronavirus infections in vaccinated people began to pop up. It was this time that we learnt protection against infection becomes less robust several months following vaccination for Pfizer’s or Moderna’s mRNA vaccines. But the vaccines’ original target — preventing hospitalization — remained stable, with an efficacy of between 80 percent to 95 percent.

Studies also showed that a single dose of Johnson & Johnson’s vaccine was less effective at preventing symptoms or keeping people out of the hospital than the mRNA jabs. The company claims, though, that there’s not yet evidence that the protection wanes. But even if that protection is not weakening, some real-world data hint that this vaccine may not be as effective as clinical trials had suggested.

It is against this evidence (of waning protection) that governments ultimately mooted the idea of COVID-19 booster vaccines for adults.

Concern about declining immunity came to a head amid the spread of highly contagious variants, including Alpha, first identified in the United Kingdom in September 2020, and Delta, first detected in India in October 2020. Currently, Delta is the dominant variant globally.

The good news is that vaccinated people aren’t unarmed against these mutated variants. Clinical data has demonstrated that vaccines trigger antibodies that are still able to attack Alpha and Delta, albeit with slightly less intensity than for the original Wuhan variant that emerged out of China two years ago. Antibodies also still recognize more immune-evasive variants such as beta, first identified in South Africa in May 2020, and gamma, identified in Brazil in November 2020. Although protection against infection dips against many of these variants, vaccinated people remain much less likely to be hospitalized compared with unvaccinated people.

Experts will continue to track how well the vaccines are doing, especially as new variants, like Omicron, emerge. In late November, the World Health Organization designated the omicron variant as the latest variant of concern after researchers in South Africa, and warned that it carries several worrisome mutations. Preliminary studies suggest that Omicron can reinfect people who have already recovered from an infection. The variant is at least as transmissible as Delta. We now know that Omicron may affect vaccine effectiveness. Pfizer-BioNTech’s two-dose vaccine, for instance, is about 30 percent effective at preventing symptoms from Omicron infections while a booster could increase effectiveness back up to more than 70 percent, according to estimates from Public Health England.

Vaccines are safe, with few serious side effects

With close to nine billion of doses administered around the world as of year-end, the shots have proved not only effective, but also remarkably safe, with few serious side effects.

Commonly reported side effects include pain, redness or swelling at the spot of the shot, muscle aches, fatigue, fever, chills or a headache. These symptoms usually last only a day or two.

But more rare and serious side effects have also been reported. However, none are unique to these vaccines. In deed other vaccines — and infectious diseases, including COVID-19 — also cause these adverse effects.

One example is myocarditis and pericarditis. Current estimates are a bit fluid since existing studies have different populations and other variables. However, two large studies in Israel estimated that the risk of myocarditis after an mRNA vaccine to about 4 of every 100,000 males and 0.23 to 0.46 of every 100,000 females. Researchers also reported in October in the New England Journal of Medicine. Yet members of Kaiser Permanente Southern California who had gotten mRNA vaccines developed myocarditis at a much lower rate: 5.8 cases for every 1 million second doses given, researchers reported, also in October, in JAMA Internal Medicine.

What all the studies have in common is that young males in their teens and 20s are at highest risk of developing the side effect, and that risk is highest after the second vaccine dose. But it’s still fairly rare, topping out at about 15 cases for every 100,000 vaccinated males ages 16 to 19, according to the larger of the two Israeli studies. Males in that age group are also at the highest risk of getting myocarditis and pericarditis from any cause, including from COVID-19.

Components of the mRNA vaccines may also cause allergic reactions, including potentially life-threatening anaphylaxis. The U.S. Centers for Disease Control and Prevention calculated that anaphylaxis happens at a rate of about 0.025 to 0.047 cases for every 10,000 vaccine doses given.

But a study of almost 65,000 health care system employees in Massachusetts suggests the rate may be as high as 2.47 per 10,000 vaccinations, researchers reported in March in JAMA. Still, that rate is low, and people with previous histories of anaphylaxis have gotten the shots without problem. Even people who developed anaphylaxis after a first shot were able to get fully vaccinated if the second dose was broken down into smaller doses.

The only side effect of the COVID-19 vaccines not seen with other vaccines is a rare combination of blood clots accompanied by low numbers of blood-clotting platelets. Called thrombosis with thrombocytopenia syndrome, or TTS, it’s most common among women younger than 50 who got the Johnson & Johnson vaccine or a similar vaccine made by AstraZeneca that’s used around the world.

About 5 to 6 TTS cases were reported for every 1 million doses of the J&J vaccine, the company reported to the U.S. Food and Drug Administration. The clots may result from antibodies triggering a person’s platelets to form clots. Such antibodies also cause blood clots in COVID-19 patients, and the risk of developing strokes or clots from the disease is much higher than with the vaccine. In one study, 42.8 of every 1 million COVID-19 patients developed one type of blood clot in the brain, and 392.3 per 1 million developed a type of abdominal blood clot, researchers reported in EClinicalMedicine in September.

Getting everyone vaccinated is not easy

The quest to vaccinate as many people as quickly as possible last year faced two main challenges: getting the vaccine to people and convincing them to take it. Strategies employed so far — incentives, mandates and making shots accessible — have had varying levels of success.

“It’s an incredibly ambitious goal to try to get the large majority of the country and the globe vaccinated in a very short time period with a brand-new vaccine,” says psychologist Gretchen Chapman of Carnegie Mellon University in Pittsburgh, who researches vaccine acceptance. Usually “it takes a number of years before you get that kind of coverage.”

Globally, that’s sure to be the case due to a lack of access to vaccines, particularly in middle- and lower-income countries. The World Health Organization set a goal to have 40 percent of people in all countries vaccinated by year’s end. But dozens of countries, mostly in Africa and parts of Asia, are likely to fall far short of that goal.

In contrast, the United States and other wealthy countries got their hands on more than enough doses. Here, the push to vaccinate started out with a scramble to reserve scarce appointments for a free shot at limited vaccination sites. But by late spring, eligible people could pop into their pharmacy or grocery store. Some workplaces offered vaccines on-site. For underserved communities that may have a harder time accessing such vaccines, more targeted approaches where shots are delivered by trusted sources at community events proved they could boost vaccination numbers.

Simply making the shot easy to get has driven much of the progress made so far, Chapman says. But getting people who are less enthusiastic has proved more challenging. Many governments and companies have tried to prod people, initially with incentives, later with mandates.

Free doughnuts, direct cash payments and entry into million-dollar lottery jackpots were among the many perks rolled out. Before the pandemic, such incentives had been shown to prompt some people to get vaccines, says Harsha Thirumurthy, a behavioral economist at the University of Pennsylvania. This time, those incentives made little difference nationwide, Thirumurthy and his colleagues reported in September in a preliminary study posted to SSRN, a social sciences preprint website. “It’s possible they moved the needle 1 or 2 percentage points, but we’ve ruled out that they had a large effect,” he says. Some studies of incentives offered by individual states have found a marginal benefit.

“People who are worried about side effects or safety are going to be more difficult to reach,” says Melanie Kornides, an epidemiologist at the University of Pennsylvania. And with vaccination status tangled up in personal identity, “you’re just not going to influence lots of people with a mass communication campaign right now; it’s really about individual conversations,” she says, preferably with someone trusted.

As COVID-19 mandates went into effect in the fall, news headlines often focused on protests and refusals. Yet early anecdotal evidence suggests some mandates have helped. For instance, after New York City public schools announced a vaccine requirement in late August for its roughly 150,000 employees, nearly 96 percent had received at least one shot by early November. Still, about 8,000 employees opted not to get vaccinated and were placed on unpaid leave, the New York Times reported.

Many people remain vehemently opposed to the vaccines, in part because of rampant misinformation that can spread quickly online. Whether more mandates, from the government or private companies, and targeted outreach will convince them remains to be seen. — Jonathan Lambert

Vaccines can’t single-handedly end the pandemic

One year in, it’s clear that vaccination is one of the best tools we have to control COVID-19. But it’s also clear vaccines alone can’t end the pandemic.

While the jabs do a pretty good job preventing infections, that protection wanes over time. Still, the vaccines have “worked spectacularly well” at protecting most people from severe disease. As more people around the world get vaccinated, fewer people die, even if they do fall ill with COVID-19.

“We have to make a distinction between the superficial infections you can get — [like a] runny nose — versus the lower respiratory tract stuff that can kill you,” such as inflammation in the lungs that causes low oxygen levels, Luning Prak says. Preventing severe disease is the fundamental target that most vaccines, including the flu shot, hit, she notes. Stopping infection entirely “was never a realistic goal.”

Because vaccines aren’t an impenetrable barrier against the virus, we’ll still need to rely on other tactics to help control spread amid the pandemic. “Vaccines are not the sole tool in our toolbox,” says Saad Omer, an epidemiologist at Yale University. “They should be used with other things,” such as masks to help block exposure and COVID-19 tests to help people know when they should stay home.

For now, it’s crucial to have such layered protection, Omer says. “But in the long run, I think vaccines provide a way to get back to at least a new normal.” With vaccines, people can gather at school, concerts or weddings with less fear of a large outbreak.

Eventually the pandemic will end, though when is still anyone’s guess. But the end certainly won’t mean that COVID-19 has disappeared.

Many experts agree that the coronavirus will most likely remain with us for the foreseeable future, sparking outbreaks in places where there are pockets of susceptible people. Susceptibility can come in many forms: Young children who have never encountered the virus before and can’t yet get vaccinated, people who choose not to get the vaccine and people whose immunity has waned after an infection or vaccination. Or the virus may evolve in ways that help it evade the immune system.

The pandemic’s end may still feel out of reach, with the high hopes from the beginning of 2021 a distant memory. Still, hints of normalcy have returned: Kids are back in school, restaurants and stores are open and people are traveling more.

References and Citations

Johnson & Johnson. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Press release, September 21, 2021.

W.H. Self et al. Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions — United States, March – August 2021. Morbidity and Mortality Weekly Report. Vol. 70, September 24, 2021, p. 1337. doi: 10.15585/mmwr.mm7038e1.

Witberg, et al. Myocarditis after COVID-19 vaccination in a large health care organization.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2110737.

Mevorach, et al. Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in Israel.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2109730.

Simone, et al. Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or older. JAMA Internal Medicine. Published online October 4, 2021. doi:10.1001/jamainternmed.2021.5511.

G. Blumenthal, et al. Acute allergic reactions to mRNA COVID-19 vaccines. JAMA. Vol. 325, March 8, 2021, p. 1562. doi:10.1001/jama.2021.3976.

Janssen Biotech, Inc. Briefing material. U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee meeting. October 15, 2021.

Taquet et al. Cerebral venous thrombosis and portal vein thrombosis: A retrospective cohort study of 537,913 COVID-19 cases. EClinicalMedicine. July 31, 2021. doi: 10.1016/j.eclinm.2021.101061.

Thirumurthy et al. Association between statewide financial incentive programs and COVID-19 vaccination rates. Posted September 3, 2021. doi: 10.2139/ssrn.3912786.

  1. Lytras et al. Interventions to increase seasonal influenza vaccine coverage in healthcare workers: A systematic review and meta-regression analysis. Human Vaccines and Immunotherapeutics. Vol 12, May 5, 2016 p. 671. doi: 10.1080/21645515.2015.1106656.

Economic Outlook for Pharma in 2022

Throughout 2020 and 2021, navigating the pandemic has been an all-consuming endeavour for all sectors. As the pandemic raged, pharma responded with leadership and purpose, managing to deliver a vaccine in record time. However, with the looming energy crisis, supply chain crunch and labour market tightening all coming to a head, the question on most people’s minds is what does the economy hold out for pharma in 2022 and beyond?

Economic picture

Last month, leading economists at the World Bank, the International Monetary Fund, the OECD and the Conference Board released global economic growth forecasts for 2022 through to 2026.

World growth for 2022 is forecast at 3.9%; with growth across all mature economies forecast to be up by 3.9%. The US and China, the main engines of global economic growth are expected to grow at 3.8% and 5.5% respectively.


Real GDP (average annual) % change Actual Actual Actual Estimate Forecast Forecast Trend
2000-2009 2010-2019 2020 2021 2022 2023 2022-2026
United States 1.9 2.2 -3.4 5.7 3.8 3 2.1
Europe 1.7 1.7 -6.6 5 4.1 1.7 1.2
Euro Area 1.4 1.3 -6.9 4.7 3.9 1.5 1
United Kingdom 1.6 2 -9.7 7 4.5 1.4 1.1
Japan 0.4 1.2 -4.7 2.5 3.3 1.4 0.8
All mature economies 1.8 2 -4.6 5.1 3.9 2.3 1.7
China 8.9 6.3 2.2 5 3.3 3.2 3.7
India 6.8 7.2 -7.1 7.5 8.5 4.3 4
Brazil 3.4 1.4 -4.4 5.2 1.5 1.7 1.6
Russia 5.4 2 -2.9 4.5 2.1 1.8 1.6
Turkey 3.9 5.8 1.6 8.9 2.5 3.3 3.6
All emerging econo 5.7 4.7 -2.1 5.2 4 3.2 3.2
World 3.4 3.3 -3.3 5.1 3.9 2.8 2.5


The pharmaceuticals market is expected to grow, fuelled by new scientific and operational opportunities, as companies rearrange their operations and recover from COVID-19 , which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $1700.97 billion in 2025 at a CAGR of 8%.

Among the upside and downside risks identified in the forecast, global supply chain problems, labour issues, and businesses technology investments pause the greatest risks to growth.

Supply chain

The reason supply chain problems are concerning this time round is that, unlike past disruptions (from natural disasters, international trade tensions, cyberattacks, and even, the global pandemic), the current crises appears much harder to resolve.

There is little companies or a single sector can do when its cargo ships are having to wait to unload in goods in ports. The current crisis is compounded by energy price inflation, and the resulting shortages of critical inputs, such as active pharmaceutical ingredients and excipients. This is why this supply shock has no quick fixes, and a rapid return to business as usual does not seem to be on the horizon, anytime soon.

Labour shortages

Labour shortages are crucial to growth. The economists believe that to a certain extent, workers have become more selective in the kind of work they’re taking on post-pandemic. We think this argument is overly simplified and the reality is far more complex.

Taking the US as a case study, three million more workers retired than were expected to retire during the pandemic. In part, this was because older workers are at greater risk of being harmed by COVID. But many older workers found that their retirement plans, and the value of their homes, increased significantly in value. On the other hand, younger workers have had more choices for work.

To attract the workers needed, companies are having to pay new workers higher wages and offer better benefit plans. As the young go back to work in 2022, the need to do this will decrease.

Demographic issues, in the longer term, will also contribute to a shortage in workers. The citizenry is aging in the established economies as well as China. To overcome this, businesses are increasingly investing in digital technologies.

However, one economist warned, the decade before the pandemic hit had the slowest growth in productivity in many decades. Nonetheless, in certain industries, technology is clearly replacing humans and that the pandemic has helped accelerate this shift.

While supply chain and labour issues will depress growth, it is important to put this in perspective. Global economies will grow significantly faster than is the norm.

You can read the report in its entirety through this link.

Global Economic Outlook 2022: Global GDP growth forecast (

Additional reporting by Niall P Hughes

The Use of FT-Raman Spectroscopy Maps to Predict Excipient-Drug Blend Uniformity

Luis Carey and Danna Ritter | Guest Writers

This study explores the use of Raman mapping to monitor blend homogeneity and low dose content uniformity of active pharmaceutical ingredients in excipient blends. Compared with wet chemistry analytical methods, this technique offers a high spatial resolution (several µm), allows the identification of specific components using marker vibrational bands and is non-destructive.


Direct compression is by far the most preferred technique in pharmaceutical R&D and tablet production. It involves simply blending the active pharmaceutical ingredient with appropriately selected excipients which are then compressed into tablets. Thus, it eliminates many of the tedious steps that accompany wet granulation.

However, direct tablet compression can be challenging for low dose, highly lipophilic drug substances when it comes to physical stability, blend homogeneity and ultimately, content uniformity. Particular attention needs to be paid to the types of filler-diluent selected as it constitutes the bulk of the formulation.

It has also been suggested that some excipients that are fibrous in nature are ideally suited to direct compression of low dose formulations because they can help trap and ‘bind’ the active drug substance thereby preventing segregation. For more on formulation of low dose see Rohrs, Amidon and Meury et al (2006) article on formulation of low dose formulations here.

During new formulation development, it is vitally important for formulators to have access to simple but effective methods to study drug-excipient interactions beforehand as opposed to laborious wet chemistry techniques that are typically used. Furthermore, assessing the content uniformity this way requires grinding 20 or more tablets which can easily hide variations that would otherwise be visible in physical blends.

By investigating different excipients with a low dose of an API during the blending process it is possible to increase the probability of consistently producing a solid dosage form with acceptable and consistent homogeneity.

In this study, we selected three commonly used functional excipients, namely, pregelatinised starch (LYCATAB® – Roquette), Calcium Phosphate Dihydrate (EMCOMPRESS® – JRS Pharma) and Spray dried lactose (FASTFLOW® – Kerry) commonly used in the formulation of a wide range of solid dosage forms. The aim was to understand the mechanisms behind the physical interactions of the excipients with a micronized, lipophilic drug candidate using Raman FTIR spectroscopy.


Blends of indomethacin {m.w 357.79, calculated log P 4.18, D (v,4,3) 9.497)] and pregelatinized starch, spray dried lactose and calcium phosphate dihydrate were dry blended in an Apex double cone blender for 10 minutes. Samples (200 mg) were removed in triplicate from different positions within the blender using a stratified sampling technique.

Scanning electron microscope (SEM) is a type of electron microscope capable of producing high resolution images of a sample surface. Due to the manner in which the image is created they have a characteristic three-dimensional appearance and are useful for judging surface structure. SEM images were obtained for indomethacin, pregelatinized starch, spray dried lactose and calcium phosphate dihydrate and the blends thereof. The images were used to approximate particle size and investigate the nature of the interaction between the excipient and the active drug substance.

Laser sizing – Light from a laser is shone into a cloud of particles which are suspended in a transparent gas e.g. air. The particles scatter the light, smaller particles scattering the light at larger angles than bigger particles. The scattered light can be measured by a series of photodetectors placed at different angles. This is known as the diffraction pattern for the sample. The diffraction pattern can be used to measure the size of the particles using light scattering theory. Laser sizing was used to obtain the particle size of both the pregelatinised starch and indomethacin. The results were compared to those obtained by SEM to confirm particle size.

FT-Raman Spectroscopy mapping – This spectroscopic technique investigates the vibrational transitions of covalent bonds in molecules. Raman spectroscopy can be applied to a wide range of samples that includes organic and inorganic materials. FT-Raman spectra of indomethacin in the excipient blends were obtained between 0 and 4000 cm-1 using a Thermo- Nicolet NXR FT-Raman Spectrometer, equipped with a NXR Genie detector (liquid nitrogen cooled) and a computer controlled mapping stage.

Initial data acquisition was by Smart ARK and OMNIC software. The data were subsequently analyzed using the InSight chemometrics software package. A standard configuration was used to obtain a Raman spectrum from different small areas of drug and excipient blends. Vibrational bands at 1698 cm-1 (indomethacin), 363 cm-1 (lactose), 478 cm-1 (pregelatinized starch) and 988 cm-1 (calcium phosphate) were used for analyses; from which FT-Raman spectroscopic maps of the blends were obtained.

Results & Discussion

Particle size data of the materials obtained by laser sizing are given in μm in the table below. D10 means that 10% of the particles are below the value stated, similarly for D50 and D90, 50% and 90% respectively.

Material D10 D50 D90
Indomethacin 16.10 (9.63) 40.29 (29.79) 72.12 (46.77)
Starch 1500 ® 0.64 (0.03) 1.664 (0.18) 5.407 (2.21)
Lactose 12.25 (0.55) 24.26 (6.65) 53.17 (23.88)
Calcium phosphate dihydrate 10.78 (1.36) 470.3 (232) 713.2 (99.24)

Approximate sizes of the raw materials obtained by SEM are given in μm in the table below. Comments on the surface features which are expected to effect the interaction between the active pharmaceutical ingredient and the excipient are also given.

Reagent Size(μm) Comments
Indomethacin 0.5–1 Glassy, Crystalline clusters, large crystals
Starch 1500 ® 10–70 Plate–like surface, irregular
Lactose 10–100 Porous, Crystalline deep surface folds
Calcium phosphate dihydrate 10–150 Crystalline clusters, irregular, aggregates

The particle size obtained from both techniques are in very good agreement. There are some larger particles of Indomethacin than were observed by SEM however a relatively small sample is analysed by SEM whereas the laser sizing is a product of several experiments each using a few grams of sample. The particle size and nature of the surface will affect both the ‘flowability’ and lubricating nature of the drug substance and excipient when they are subjected to shear in a typical the blending process.

In the case of pregelatinized starch, it is clear that the Indomethacin is attaching to the surface of that starch particles and ‘nestling’ in the crevices between the particles. The “plate-like” shape appears to be beneficial to the interaction and the distribution of Indomethacin throughout the sample appears uniform. With respect to the Lactose monohydrate, the indomethacin is held in its pores and surface detects. It appears that there is more Indomethacin observable in the case of the pregelatinised starch. As Calcium phosphate dihydrate is comparatively more crystalline, it is more difficult to observe Indomethacin on the surface and therefore difficult to compare to the other two excipients.

In each of the following Raman maps of the indomethacin excipient blends, the marker chosen is for Indomethacin; therefore red and yellow indicate the presence of Indomethacin, green and blue indicate the lack of Indomethacin. It is postulated that the yellow is indicative of Indomethacin near the surface, whereas red is at the surface. This is because there is still the characteristic intensity associated with Indomethacin present however, in the case of the yellow bands, it is not as significant as the red implying that the laser is not as focused on the Indomethacin at this point.

Only a very small selection of the maps generated in this study are presented.

Based on spatial maps of indomethacin within the different excipients which were analysed chemometrically, the results showed that pregelatinized starch exhibited good homogeneity and had the lowest agglomeration of the active ingredient. Spray dried Lactose blends showed good homogeneity but the level of agglomeration appeared to be. Calcium phosphate blends had the poorest homogeneity and the highest agglomeration. It is hypothesized that the greater level of particle-particle shear generated during blending facilitated the attainment of more homogeneous distribution of the active ingredient with pregelatinised starch.


SEM showed that for the Calcium phosphate dihydrate the surface was crystalline and irregular whereas the lactose monohydrate it was more porous and pregelatinized starch was amorphous containing plate like structures. These properties are expected to affect the flow ability and lubricating nature of the excipients when they are subjected to shear in the blending process.

On the basis of the results of this study, the following conclusions can be drawn:

SEM can be used to visualise the distribution of Indomethacin in different blends. Calcium phosphate dihydrate proved the most difficult to interrogate as it is so crystalline and broad in its size distribution. It was difficult to observe Indomethacin on the surface. For both Spray-dried Lactose and pregelatinized starch the Indomethacin at the surface was clearly visible either held in the pores or the plate-like surface features of each excipient respectively. The porous structure of the lactose and the plate-like irregular shape of the pregelatinised starch both appear to be beneficial to the interaction and the distribution of Indomethacin throughout the sample.

Raman mapping can be used to monitor blend homogeneity and low dose content uniformity of active pharmaceutical ingredients in excipient blends. This technique offers a high spatial resolution (several µm), enables the identification of specific components using marker vibrational bands and is non-destructive. The results of this study showed that better blend homogeneity was achieved with pregelatinized starch compared with lactose or calcium phosphate.


  • B.R. Rohrs, G.E. Amidon, R.H. Meury, P.J. Secreast, H.M. King, C.J. Skoug, Particle Size Limits to Meet USP Content Uniformity Criteria for Tablets and Capsules, Journal of Pharmaceutical Sciences, 95 (2006) 1049-1059. 10.1002/jps.20587
  • M. Ficzere, L.A. Mészáros, L. Madarász, M. Novák, Z.K. Nagy, D.L. Galata, Indirect monitoring of ultralow dose API content in continuous wet granulation and tableting by machine vision, International Journal of Pharmaceutics, 607 (2021) 121008. DOI: 10.1016/j.ijpharm.2021.121008
  • V. Vanhoorne, B. Vanbillemont, J. Vercruysse, F. De Leersnyder, P. Gomes, T.D. Beer, J.P. Remon, C. Vervaet, Development of a controlled release formulation by continuous twin screw granulation: Influence of process and formulation parameters, International Journal of Pharmaceutics, 505 (2016) 61-68/ DOI: 10.1016/j.ijpharm.2016.03.058

Medication Swallowing Difficulties: The 3 Steps Needed To Improve Patient Experience

Dr. E Vickers (with additional contributions from E Mwesigwa) |

Individuals with swallowing difficulties face inequalities in their access to safe medicines and could be at a greater risk of poor health outcomes compared with the general population. This article sets out to highlight the scale of the problem and suggests actions that the pharmaceutical industry and regulators can take to improve the situation.

What are Swallowing Difficulties?

Swallowing, the act by which we ingest solid food, liquids or medication, is in fact a highly intricate process that requires the interplay of several nerves and muscles in the oral cavity, pharynx and oesophagus in order to safely transfer bolus into the stomach.

While the vast majority of us do this simple act without much thought, there are millions of people who, for one reason or another, struggle to swallow. For them, the ability to initiate and complete a normal swallow is tortuous, accompanied by anxiety, pain, choking or aspiration.

Swallowing disorders occur in all age groups, either as a result of congenital abnormalities, damage to structures in the oropharyngeal anatomical structures and or short-term or long-term medical conditions. In some age groups and populations, however, swallowing difficulties are far more significant and pernicious. For example, in children with learning disabilities as well as senior citizens who need daily medication to alleviate their conditions.

In some situation, an inability to swallow solid medication can be a matter of life and death. For instance, in those with Parkinson’s disease where 70-80% of sufferes have swallowing problems or those who have had a stroke, where swallowing difficulties run at 90%.

Read about our article on Empathy – What the pharmaceutical industry can learn from the IT Industry

The main causes of swallowing difficulties catalogued in the medical literature include:

  • Dysphagia, the most well-known among swallowing disorders, refers to a group of disorders characterised by changes in the structures or neurological control of the swallow. Studies show that dysphagia affects 3 % of the general population.
  • Odynophagia which refers to pain swallowing caused by irritation or infection of the oral mucosae and oesophagus, particularly in individuals with acquired immunodeficiency syndrome, oesophagitis or disorders of motility of the oesophagus.
  • Phagophobia which is the fear and avoidance of swallowing foods, liquids or medication, usually based on the person’s fear of choking. It is on a psychological dimension and characterized by swallowing complaints but no abnormalities upon physical examination or investigation.

Note that difficulty to swallow is not in itself a disease, rather it may be an indication of an underlying structural, neurological or other dysfunction for which proper medicare should be sought since factors that lead to abnormal swallowing, whether it is dysphagia, odynophagia or phagophobia, can be life limiting, and if severe, life threatening.

Anatomy and Physiology of Swallowing

The normal swallow permits an individual to handle a wide range of solid and liquid products of varying volumes, textures and consistencies. This process can generally be divided into different phases, depending on whether the material is a liquid or a solid.

But first, it is essential to quickly review the anatomy and physiology of swallowing as a basis for appreciating swallowing difficulties and how to design effective interventions.

The anatomy of the oral cavity, pharynx, larynx and the innervations of the muscle in the oral cavity are shown in the figure below:

The tongue has both oral and pharyngeal surfaces. The oral cavity is separated from the pharynx by the faucial pillars. The pharynx has a layer of constrictor muscles that originate on the cranium and hyoid bone, and the thyroid cartilage anteriorly.

Note that the anatomy of the head and neck of infants is different from that of adults. In infants, teeth are not erupted, the hard palate is flatter, and the larynx and hyoid bone is higher in he neck to the oral cavity. The epiglottis touches the back of the soft palate so the larynx is open to the nasopharynx, but the airway is separated from the oral cavity by a soft tissue barrier.

The physiology of normal eating and swallowing is described by two models: the four stage model for liquids and the process model for solids.

Although there are differences in the sequence of events in the two models, it is possible to reduce the swallow to three main phases as follows:

Oral Phase

Upon introducing a liquid or solid into the mouth, the material is prepared into a bolus and or transported to the middle of the tongue. During this stage, the posterior part of the oral cavity will be sealed by the action of the soft palate and tongue, thus preventing premature leakage of bolus into oropharynx before the swallow. Note that the tendency for leakage increases with age.

After a brief moment the anterior tongue rises, touching the alveolar ridge of the hard palate just behind the upper teeth. The posterior tongue drops, opening the back of the oral cavity. The surface of the tongue lifts upward, propelling the bolus back along the palate and into the pharynx.

Pharyngeal Phase

The pharyngeal swallow is a swift activity that follows the oral phase. It serves two main purposes:

(1) to permit bolus to be propelled through the pharynx and the upper oesophageal sphincter and into the oesophagus, and

(2) to protect the airway by preventing entry of food into the larynx and trachea.

In this phase, the soft palate elevates and contacts the walls of the pharynx, leading to the closure of the nasopharynx at the point the bolus hurtles into the pharynx. The base of the tongue retracts, pushing the bolus against the pharyngeal walls. Constrictor muscles of the pharynx then contract, squeezing the bolus downward, and together with retraction of the base of the tongue, pushes the bolus downward.

For obvious reasons, the ability to safely pass bolus through the pharynx without aspirating or regurgitation into the nasal cavity is important in human swallowing. Therefore, there are several mechanisms at play which the body uses to prevent entry of food particles into the airway during swallowing.

Oesophageal Phase

The oesophageal phase describes the transport of the bolus through the oesophagus. The oesophagus is a tube-shaped structure originating from the lower part of the upper oesophageal sphincter and terminating at the lower oesophageal sphincter.

During the swallow, the muscles relax allowing the bolus to pass down. Movement is facilitated by a series of peristaltic waves, as well as gravity, both of which effectively transport the bolus through lower oesophageal sphincter and into the stomach.

Swallowing Abnormalities

Abnormal swallowing can result from a wide range of conditions and disorders related to the anatomy and or physiology or the oral, pharyngeal and oesophageal dysfunction.

Swallowing difficulties manifest in different ways, which include:

  • Painful chewing or swallowing
  • Dry mouth (Xerostomina)
  • Difficulty controlling solids or liquids in the mouth
  • Hoarse or wet voice quality
  • Coughing or chocking before, during or after swallowing
  • Feeling of obstruction (globus sensation)


Dysphagia arises from abnormalities in structure or motility and ranges from inability to initiate swallowing to solids getting stuck in the oesophagus.

Generally, two main types of dysphagia are recognised:

Oropharyngeal dysphagia, whereby patients are unable to transfer food into the oesophagus by swallowing. Oropharyngeal dysphagia is subdivided into structural/obstructive and neurological/propulsive.

From a clinical point of view, any difficulties swallowing solids indicates either structural or propulsive oropharyngeal dysphagia, while difficulty swallowing liquids indicates propulsive or neurological oropharyngeal dysphagia.

Oesophageal dysphagia is when patients can initiate swallowing process however as the food passes down the oesophagus and into the stomach, they experience discomfort. The underlying causes can also be structural or propulsive abnormalities.

The table below lists some of the most common causes of oral and pharyngeal dysphagia

Common Causes of Oral and Pharyngeal Dysphagia

Neurological disorders and stroke Structural lesions Psychiatric disorders
Cerebral infarction

Brain-stem infarction

Intracranial haemorrhage

Parkinson’s disease

Multiple sclerosis

Motor neurone disease


Myasthenia gravis



Forestier’s disease

Congenital web

Zenker’s diverticulum

Ingestion of caustic material


Psychogenic dysphagia



Connective tissue diseases: Polymyositis & Muscular Dystrophy


Iatrogenic Causes:

Surgical resection

Radiation fibrosis


From: Palmer Jb et al, 2006. In Braddom R (ed): Physical Medicine and Rehabilitation, Elsevier, Philadelphia. Pp 597-616.


Odynophagia is the disorder in which swallowing is associated with pain. It differs from dysphagia, which is simply difficulty when swallowing — and does not associate with pain, whereas odynophagia always does.

Odynophagia can be caused by infective and non-infective inflammatory processes, benign and malignant esophageal disorders such as achalasia, gastro-esophageal reflux disease and carcinoma.

Some of the conditions associated with odynophagia include:

  • Gastroesophageal Reflux Disease
  • Esophagitis
  • Candidiasis
  • Esophageal Cancer


Phagophobia is a relatively rare type of anxiety disorder associated with swallowing. It is often mixed up with pseudodysphagia, which is the fear of choking. The key difference between these two phobias is that individuals with phagophobia are anxious about the act of swallowing whereas those with pseudophagia are afraid that swallowing will lead to choking.

Irrespective, phagophobia and pseudodysphagia can be life limiting, and in the case of medication, life threatening. This is especially the case in the small but significant cohort of individuals, who for reasons still to be known, have phagophobia and pseudodysphagia related to medication.

Unfortunately, the causes of phagophobia are poorly understood and may even be multifactorial, involve past experiences, underlying health conditions or simply learned through observing others who struggle to swallow certain things.

It has been found that individuals who watch others experience difficulties (e.g pain or embarrassment) when swallowing may go on to develop phagophobia.

Finally, phagophobia may occur in the absence of any underlying triggers.

Symptoms of phagophobia include:

  • Anticipatory anxieties before ingestion of meals
  • The tendency to eat very small mouthfuls or drinking frequently or large amounts of liquids during meals as a way to aid swallowing
  • Extreme anxiety and fear at the thought of swallowing
  • Panic attacks
  • Rapid heart rate and breathing
  • Reluctance or avoidance of eating or drinking in front of others
  • Sweating
  • Switching to an all-liquid diet as a way to alleviate anxiety around swallowing
  • Weight loss (skipping medication and exacerbation of illness if related to medication)

Oral Medicines and Swallowing Difficulties

The prevalence of swallowing difficulties varies greatly, including population under consideration, comorbidities and assessment methods. Experts contend that prevalence may actually be greater than published figures would indicate since many patients may not report symptoms.

Generally, 70 – 90% of all seniors have some degree of swallowing difficulty. In certain cases, for instance, Parkinson’s disease and Stroke, swallowing difficulties are the norm, and have been reported to be as high as 90%. According to a recent study, swallowing difficulties run at 3% in the world adult population, but are 10 times higher in those with neurological and or psychological conditions, such as learning disabilities, severe mental illness or dementia.

With oral administration of medication being the most preferred route, the swallowing of solid medication, particularly tablets and capsules, presents specific challenges to anybody with swallowing problems. To make matters worse, solid dosage forms need to be taken with water, which requires the same individuals to control a thin fluid, which complicates matters even more.

Which medication types are suitable for dysphagia and other swallowing difficulties?

Most medication in use today is formulated as tablet dosage forms. According to the British Pharmacopoeia, a tablet is circular in shape with either a flat or convex faces prepared by compressing the active pharmaceutical ingredients with excipients.

In reality, they are available in a wide range of sizes, shapes, colours and indentations. In addition, tablets may be sugar or polymer film coated as well.

The oral route of drug administration is the most preferred route of taking medicine, and understandably, manufacturers of medicines recognise this. As a result, oral medicines account for more than 70% of all medicines in use.

Tablets (and more specifically, standard compressed tablets) are the single most popular dosage form, responsible for 50% of all pharmaceutical preparations manufactured and sold. Some of the reasons for popularity of tablets include:

  • Tablets allow accurate dosage of medicament to be prefabricated and administered simply and conveniently
  • Tablets are consistent with respect to weight and appearance
  • Drug release rate can be fine-tuned to meet physiological and pharmacological needs of patients
  • Tablets can be mass-produced simply and quickly, which allows the wider public to have access to medicines that would otherwise be too costly.

However, to anyone with swallowing difficulties, swallowable tablets are a nightmare. Problems with the neural control or the structures involved in swallowing mean that swallowable tablets are not ideal sufferers of dysphagia. Too big (frankly, most are) and they are a choking hazard. Too small and they become difficult to detect on the tongue and move around in the mouth to initiate a safe swallow.

If the tablets can be crushed beforehand, it can greatly help pass them down however, as with anything that requires precision, the possibility of errors increases with the number of additional manipulations. Thus, having technologies that enable dosing without the need for additional dilution, elaboration or mixing as is always needed in paediatric, geriatric or other swallowing disorders would be of great benefit.

There are alternatives to swallowable tablets, which depending on the type of drug substance and its intended use, may be considered:

  • Buccal Tablets
  • Caplets and Coated Tablets
  • Chewable tablets
  • Effervescent Tablets
  • Lozenges
  • Mintablets
  • Multiparticulates
  • Orally Disintegrating Tablets (ODTs)
  • Powders for reconstitution
  • Sublingual Tablets
  • Hard Gelatin Capsules
  • Soft Gelatin Capsules
  • Chewing Gums
  • Gummies
  • Topical Products (Ointments, Creams, Lotions and Transdermal Patches)
  • Parenteral Products
  • Inhalation Products

Join Our Campaign for Improved Access to Easy-to-Swallow Medicines

[quform id=”22″ name=”Campaign”]

Key Characteristics of Different Tablets Types

Type of tabletsDescription and AdvantagesKey Considerations
Swallow TabletsThe vast majority of tablets fall in this category. These tablets are designed for per-oral administration by swallowingMost tablets belong to this category. They are designed to be swallowed whole although some may be crushed/split up to ease ingestion.
Buccal TabletsBuccal tablets are designed to be placed under the cheek mucosa or between the lip and gum. Typically designed for slow release and absorption.Buccal tablets permit administration without the requirement for water/swallowing Drugs should not be bitter or unpleasant in the mouth Usually very small and flat and do not require addition of a disintegrant
Sublingual TabletsSublingual are designed to be placed under the tongue. Unlike buccal tablets, they allow rapid absorption through blood vessels under the tongue while avoiding 1st-pass effect.Sublingual tablets permit administration without the requirement for water/swallowing Drugs should be soluble, typically low dose and not be bitter or unpleasant in the mouth Careful selection of excipients required
Orally Disintegrating Tablets (ODTs)ODTs are designed to rapidly disintegrate on the tongue into a smooth solution or suspension that can be swallowed without the need for water.Two key characteristics that a dosage form labelled as an ODT must possess is a rapid disintegration time of 30 s or less, and a tablet weight of 500 mg or less
Chewable TabletsChewable tablets consist of a mild effervescent excipient base which can be chewed and broken down into a smooth consistency which can be swallowed.To provide fast disintegration and dissolution, the tablet should be designed to be soft or easy to chew. The active drug substance must not be unpleasant to the taste, and frequently, flavours and sweeteners are required.

Unfortunately, too many products on the market today are formulated with little consideration of those with swallowing difficulties. Products for children are perforce prepared from products designed for adults; and the same applies for the elderly, who often have swallowing problems while also requiring prolonged, non-crushable tablets. In 2020, for instance, out of the 200 best-selling medicines in the United States, only six were offered in easy-to-swallow formats. It is not funny any longer. It is unsafe and something needs to be done soon.

That people have to crush medication in the 21st century so that children and seniors can be treated despite the wide availability of technologies and excipients and knowhow is disgraceful.

Actions needed to reduce inequalities in dysphagia

The prescription remains the most widely used medical intervention today. Yet it is estimated that up to 50 % of all patients prescribed medication fail to take it correctly. This not only leads to waste of resources but could lead to treatment failure and sub-optimal outcomes.

If society is to equitably offer quality healthcare to all, it will be necessary to take a whole person approach, by recognising the many root causes of inequality, and engender system-wide action, from regulators, pharmaceutical companies, patient groups as well as healthcare workers as the immediate contact points for patients.

Here is a range of preventative actions that local areas can take to reduce inequalities and improve health outcomes and the lives of people with mental illness.

1. A better understanding of the scale of the problem

Although dysphagia and other swallowing disorders are widespread, the scale of the problem, especially as it relates to medication, is still poorly understood.

It is generally known that patients, for one reason or another, tend to underreport their problems during contact with healthcare providers. The lack of understanding on the scale of the problem generally hinders society’s ability to deliver equitable healthcare.

Therefore, investment in data gathering is urgently required if we are to fully understand the scale of this problem. When delivering care, providers and institutions need to ask patients if they have issues swallowing solid medicines and know the implications of not offering working solutions.

In the 21st century, it is not just a patients’ physical comfort that is important but also their emotional well-being. This way, more joined-up interventions can be implemented.

2. Partnership between the public, government and pharmaceutical companies

With growing healthcare needs, increasing expectations from the health systems, and challenges of insufficient resources, it is unlikely that health services can be provided solely by a single actor. More than ever before, healthcare requires profit and social purpose to converge.

Public-private partnerships (PPPs) have traditionally taken many forms, varying in the level of participation or risk taken by different parties. We are not talking about PPPs as such, but rather, collaborative framework in which patient organizations, the pharmaceutical industry and healthcare providers work together, get closer to patients and gain deeper insights about their individual issues and not just as patients.

Although there is no-one-size-fits-all model, such a collaborative model can actually facilitate development of better therapies.

3. Legislation and incentivisation of marketing authorisation applicants

Providing medicines for marginalised or neglected demographics, such as those with swallowing problems, has been an endemic oversight in the pharmaceutical industry. This has been partly because marginal groups have not always been a viable commercial market or because companies were simply not bothered.

Given how prevalent dysphagia and other swallowing issues are, urgent action is required. There is need to join forces to pressure regulators and drug producers to address this inequality. One way is to require applicants for marketing authorisations to provide introduce alternative formats aimed at those with swallowing difficulties at launch in return for reduced regulatory fees or marketing exclusions.

It is clear that the current strategy of relying on the largesse of individual companies is not working, and a more sustainable approach is required.

Final thoughts

The vast majority of medication available today is in the form of swallowable tablets. These formats are often not appropriate for patients with dysphagia or other swallowing difficulties. Lack of availability of suitable formats for suffers predisposes these groups to sub-optimal treatments and contributes to healthcare inequalities.

If society is to equitably offer quality healthcare to all, it is necessary to take a whole person approach, recognise the many root causes of inequality, and engender system-wide action, from regulators, pharmaceutical companies, patient groups as well as healthcare workers as the immediate contact points for patients.

Sources Used

Overview of Drug Therapy in Older Adults. The Merck Mannual. (available at

Wright, D., 2014. Prescribing Medicines for Patients with Dysphagia. New York: Grosvenor House Publishing, pp.1-101.

Lisa Tews, Jodi Robinson.,2007. Dysphagia. In Kauffman T, L et al., (editors). Geriatric Rehabilitation Manual (Second Edition), Churchill Livingstone, pp 381-385. (

Dysphagia. National Institute on Deafness and other Communication Disorders. (available at

Back to Top
Product has been added to your cart