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Investigation of Drug Degradation in Moisture Barrier Coated Non-Hygroscopic Tablets

October 30, 2021

*Bricklane Innovations

St Johns Innovation Centre

Milton, Cambridge CB4 0WS

 

**Department of Pharmaceutics

UCL School of Pharmacy, University of London

29-39 Brunswick Square

London WC1N 1AX

Abstract

This study investigated the moisture barrier performance of polymer film coatings on a low hygroscopic tablet formulation based on dibasic calcium phosphate dihydrate and aspirin. Tablets were prepared by direct compaction and coated with aqueous dispersions of Eudragit® L30 D-55, Eudragit® EPO, Opadry® AMB and Sepifilm® LP.

Moisture uptake was studied by dynamic vapour sorption at 0 and 75% RH (25 oC). Stability was studied at 75 %RH/25 oC for 120 days and HPLC assay used to determine aspirin content.

Uncoated tablet cores equilibrated rapidly and took up very little water (0.11±0.006 %), confirming their low hygroscopicity. The amounts for coated cores varied as follows: 0.19±0.001 (Eudragit L30 D-55), 0.35±0.005 (Opadry AMB), 0.49±0.006 (Sepifilm LP) and 0.75±0.008 (Eudragit EPO) indicating that coated cores had higher uptake.

There was a progressive decrease in the strength of aspirin in all the samples studied, with the coated cores showing more pronounced degradation of the active (mean % aspirin recovered after 4 months was 80.02±0.04 for uncoated cores compared with 78.75±0.30 for cores coated with Eudragit L30 D-55, 76.15±0.55 for Opadry AMB, 75.98±1.25 for Sepifilm LP and 66.45±1.13 for Eudragit EPO).

It is concluded that the benefits of using polymer films as moisture barrier coatings to increase drug stability in tablet formulations of low hygroscopicity are limited.

1 Introduction

Many physical and chemical properties of pharmaceutical substances are modified when they take up appreciable amounts of water (Dawoodbhai and Rhodes, 1989). During pre-manufacture processing, raw materials may come into contact with water, and some moisture may be retained as a result. Finished products can also become exposed to water vapour during manufacture, for instance while in temporary storage in the warehouse before packaging or even when in use by the patient. Water sorbed this way has the potential to alter functionality of the product, including key properties like disintegration and dissolution, and chemical and physical stability (Carstensen, 1988). For many drug products, especially those with moisture-sensitive ingredients, preventing water uptake is a key objective.

There are many ways of minimizing water uptake into dosage forms and/or preventing its interaction with active drug substances susceptible to hydrolysis. One approach involves the careful selection of excipients that are able to bind or repel water. When combined with a variety of technologies and packaging solutions, the deleterious effects of environmental water can be mitigated (Zografi and Kontny, 1986; Ahlneck and Zografi, 1990; Alvarez-Lorenzo et al, 2000).

A relatively recent innovation is the application of polymer film coatings with moisture barrier properties onto actual unit solid dosage forms (Mwesigwa et al., 2005). This approach is attractive since it provides a means of limiting moisture uptake into the product in addition to the usual benefits associated with application of polymer film coatings.

An ideal moisture barrier coating should exhibit low permeability to water vapour. Additionally, the coating should have a high moisture binding capacity so that any sorbed water can be prevented from reaching into the core.

In previous studies, the moisture uptake and permeability characteristics of polymer films commonly used as moisture barrier coatings were described (Eudragit L30 D-55, Eudragit EPO, Opadry AMB and Sepifilm LP).

These studies showed that polymer films exhibited complex moisture sorption behaviour with no discernable differentiation of permeability characteristics on the basis of hygroscopicity. Crucially for moisture barriers, there was no relationship between either sorption or permeability characteristics of cast films and functionality as protective coatings after application onto hygroscopic tablet cores. Our studies found that the levels of aspirin degradation were inexplicably higher in the coated cores than the uncoated cores despite coated samples achieving a net reduction in moisture uptake.

The purpose of the current study therefore was to investigate whether the same moisture barrier polymer films applied onto a non-hygroscopic tablet core might offer better protection and ensure the stability of a hydrolysable active drug substance.

2 Materials and Methods

2.1 Materials

Poly(methacrylic acid ethyl acrylate) copolymer (Eudragit L30 D-55, Evonik, Darmstadt, Germany), poly(butyl methacrylate (2-dimethylaminoethyl) methacrylate methyl methacrylate copolymer (Eudragit EPO, Evonik), a polyvinyl alcohol (PVA) – based coating system (Opadry AMB, Colorcon, Dartford, UK); and a hypromellose-based coating system (Sepifilm LP 014, Seppic, Paris, France) were free samples from the respective vendors.

Dibasic calcium phosphate dihydrate (Emcompress, JRS Pharma, Rosenberg, Germany) was purchased from JRS Pharma. Aspirin (USP Grade), triethyl citrate, talc, titanium dioxide, poly ethylene glycol (PEG) 6000, stearic acid, magnesium stearate, sodium lauryl sulphate, and carboxy methylcellulose sodium were all purchased from Sigma Aldrich (Dorset, UK).

2.2 Methods

2.2.1 Tablet Preparation and Coating

Tablet cores were obtained by direct compression and were based on aspirin (30%), dibasic calcium phosphate dihydrate (69.5%) and stearic acid (0.5%) using an eccentric tablet press (Manesty, Merseyside, UK). The tablet target weight was 200 mg and a breaking force strength of ≥ 70N.

Tablet core coating was undertaken in a laboratory-scale fluidized bed coater (Aeromatic-Fielder AG, Switzerland) at 40 oC. The coatings vendors’ recommended guidelines were followed to achieve theoretical dry weight gains of 1.8 % (Eudragit L30 D-55), 6.4% (Eudragit EPO), 4% (Opadry AMB), and 3 % (Sepifilm LP).

All coated and uncoated samples cores were thoroughly dried in a vacuum oven (for six hours at 40 oC) and stored in closed bottles over phosphorous pentoxide dessicant pending further tests.

The aspirin activity remaining in the tablet cores after coating application was compared with that of uncoated tablets. The degradation in coated samples was found to be less than 0.1 %.

2.2.2 Equilibrium Moisture Sorption-Desorption Studies

Moisture sorption characteristics of uncoated and coated tablet cores were studied in a dynamic vapour sorption apparatus (DVS 1, Surface Measurement Systems, London, UK).

Relative humidity (RH) was programmed to expose samples at 0% RH and then automatically switch to 75 %RH. The equilibration condition for each RH stage was set at a mass change rate of 0.001 %/min between two consecutive measurements.

All experiments were performed in triplicate at 25 oC. The results of water uptake are reported as the per cent dry basis (db) versus exposure time.

2.2.3 Aspirin Stability Studies

Stability studies were undertaken at 75% RH/25 oC in sealed glass desiccators, which were placed in a thermostatted incubator (Sanyo-Gallenkamp, Loughborough, UK). The RH condition was provided by a NaCl slurry. Sampling was undertaken periodically once a month for a total period of four months.

2.2.4 HPLC Assay

A previously validated HPLC method (Fogel et al, 1984) was used (with minor modification) with to assay the retained strength of aspirin with the tablets. The HPLC conditions were an integrated HP 1050 Series HPLC system, an Agilent Zorbax Exclipse XDB–C8 4.6×150 mm column and a water-acetonitrile system (75:25) acidified with orthophosphoric acid as the mobile phase.

3 Results and Discussion

The specific equilibrium moisture uptake data at the 0-90% RH/25C cycle for uncoated and coated tablet cores are shown in Fig. 1. We elected to use this cycle to illustrate the sorption patterns otherwise the rest of the data and analysis are based on the 0-75%/25C cycles.

The data show that uncoated cores equilibrated rapidly (within 50 min) and took up very little water (0.11 ±0.006 % dry basis). When contrasted with hygroscopic cores under the same studied (reported elsewhere Mwesigwa et al, 2008) showed that the uptake at 75% RH was 2.91 ± 0.011 % and equilibration time was 500 min. This therefore demonstrates that the sorptive properties of non-hygroscopic cores used in this study were limited, confirming the non-hygroscopicity of the excipients used in the formulation.

With respect to data for coated low-hygroscopic cores, it is clear that coated cores sorbed considerably more water than the uncoated samples and also took longer to equilibrate. There were further differences in sorption patterns of the different coatings. For example, Eudragit L30 D-55 and Sepifilm LP coated cores exhibited nearly similar uptake profiles (similar rates of mass change) but the total amounts of water sorbed were different. These differences are best illustrated in Figure 2, which shows the specific equilibrium mositure uptake at each time point.

The cores coated with Opadry AMB and Eudragit EPO exhibited slower rates of uptake. However, the Eudragit EPO coated core took longer to equilibrate and also sorbed the most amount of water (0.75 ± 0.008%). These results appear to suggest that application of the barrier coatings to non-hygroscopic cores did not slow the moisture uptake kinetics and may actually have “enhanced” uptake into the core. In effect, the moisture uptake characteristics obtained are from the applied films rather than the cores, the former being the more hygroscopic component.

This contrasts with the behaviour of hygroscopic cores previously reported, where it was observed that applied films resulted in a marked reduction in the water uptake and therefore thought to have contributed less to the sorption equilibrium of the cores.

Nevertheless, it should be noted that even with this apparent “enhancement”, the equilibrium total water uptake of coated non-hygroscopic cores was still only a fraction of that observed for the hygroscopic formulation (e.g., the equilibrium uptake at 75% RH for the hygroscopic core coated with Sepifilm LP was 2.18 ± 0.001 compared with 0.49 ± 0.060 for the non-hygroscopic core coated with the same polymer).

The distribution of water between the core and the applied film is an important performance characteristic of a barrier system. To determine the availability of sorbed moisture in the applied films and the tablet cores, it is necessary to recap the equilibrium moisture sorption and permeability data obtained with free standing cast films in our earlier report (Mwesigwa et al, 2008) together with the data in Fig. 1. The data showed that at 75% RH Eudragit EPO free film was the least hygroscopic with an equilibrium moisture uptake of 1.85 ± 0.255 %. The Eudragit L30 D-55 took up 2.59 ± 0.195 % db); followed by Opadry AMB (5.18 ± 1.169) and Sepifilm LP (9.64 ± 0.252 %).

In terms of permeability, the best barrier films were Eudragit EPO and Opadry AMB (permeability coefficients at 75% RH were 0.58 x10-6 and 0.69 x10-6 cm3 (STP) cm/cm2s.cmHg, respectively). Eudragit L30 D55 and Sepifilm LP free films with permeability coefficients of 1.58×10-6 and 1.92 x10-6, respectively. The data for the equilibrium sorption (in Fig. 1) provides an interesting contrast; for instance, it can be seen that cores coated with Eudragit L30 D-55 were the least hygroscopic, followed by Opadry AMB, Sepifilm and Eudragit EPO.

This suggests that the barrier properties of the films were not being replicated on the cores. This pattern becomes more clear when the distribution of the sorbed water between the film and the core is considered.

Table 1 displays the amounts (in mg) of moisture in the applied coatings (calculated from the product of the total uptake in % of the cast film and the weight in mg of applied coating) and the total water uptake (in mg) of the coated sample (being the product of % total water uptake and the weight in mg of coated sample divided by 100), and from which the amount of water that potentially reached the core can be easily obtained (being the difference of the two quantities). It can be seen that the Eudragit EPO coated samples had the highest amount of water in the core despite the low hygroscopicity and permeability of the free film. Eudragit L30 D-55 and Opadry AMB coated samples had the least quantities of water sorbed in the cores.

The behaviour of Opadry AMB system is of interest: the free film exhibited comparable permeability to that of Eudragit EPO but had much higher hygrocopicity, on the core, this film showed lower levels of water ingress into the core, which were comparable to Eudragit L30 D-55. Therefore, as in our previous report, there appears to be no meaningful relationship that can be established between either water sorption or permeability characteristics of free films and the protective function of the coatings on non-hygroscopic tablet cores.

When a coated tablet is exposed to moisture stress, it is expected that the applied coating will either completely repel the moisture or hold a portion of the moisture and allow the excess into the underlying core depending on its permeability and the amount that the core can accommodate at the prevailing conditions. Equilibrium sorption sorption is achieved when the water activity of the sample equals that of the surroundings.

Given that the cores have lower water attracting propensity than the coatings, the sorption equilibrium is largely directed by the more hygroscopic films. Under these conditions, the cores easily reach their maximum water holding capacity and any extra sorption above this amount is taken up by the film to the point equilibration with the surrounding RH is achieved. We propose this is the reason for the observed failure of the coatings to achieve a net reduction in the total amount of water taken up over the uncoated cores. This also accounts for the observation that total sorption of low hygroscopic cores are nearly a simple sum-total of that taken up by the core and the film.

Do the above results have any bearing on stability given the relatively low water uptake in non-hygroscopic cores? Figure 3 shows the results of the stability studies of aspirin in uncoated and coated tablet cores.

Firstly, it is apparent, just like the data for hygroscopic cores, that there was a progressive decrease in the strength of aspirin upon exposure to moisture stress in all samples. By the end of study, uncoated cores exhibited the lowest levels of aspirin degradation. It is worthy emphasising at this stage that the degradation observed in the samples was solely attributed to moisture uptake post coating in the fluidised bed coater.

As it would normally be expected that samples exhibiting the highest water uptake also show the greater aspirin hydrolysis, the outcome of the stability studies does not appear paradoxical. However, when viewed in the context of the barrier characteristics of the films or the total amount of water taken in (and in comparison to the hygroscopic cores), it can be seen that despite the non-hygroscopic cores taking up only a fraction of the amount of water taken up by the hygroscopic cores, the extent of degradation was higher in these samples. Also, as no correlation between water sorption/permeability characteristics of free standing films, total water uptake of uncoated/coated cores with the extents of hydrolysis of aspirin in the cores to which the films have been applied can be established, it would suggest that the ability to prevent drug degradation in the non-hygroscopic tablet cores is not necessarily the result of preventing moisture uptake, per se.

It is already well known that excipients play an important role in the stability of moisture sensitive actives. For instance, the influence of the particle size and pore volume distribution of dibasic calcium phosphate dihydrate on the hydrolysis of aspirin has been reported (Landin et al, 1994).

Other factors, including hardness (Lee et al., 1966); excipient type and crystallinity (Maulding and Zoglio, 1969; Ahlneck and Alderborn, 1988, Du and Hoag, 2001) have been discussed. In this present study, we found that the low-hygroscopic formulation exhibited greater degradation despite the lower levels of water uptake. In this formulation, more of the sorbed moisture was available as free water, which was more available to interact with aspirin.

It is also apparent that while coated cores sorb more water than the uncoated cores, we are inclined to believe that considerably higher levels of degradation of coated non-hygroscopic cores are a result of a combination of other factors rather than water uptake alone. We have previously proposed that when coated tablets are exposed to moisture stress, the adhesion of the coating to the core is compromised and this augments the degradation of aspirin over and above the levels that would be observed through simple permeation into the core (Mwesigwa et al, 2008).

There is already a significant body of corroborating evidence to support our proposition (Okhamafe and York, 1985, Felton and McGinity, 1997). It is widely known that adhesion is of primary importance to barrier performance and its loss compromises the ability of the coating to provide mechanical protection to the substrate (Fung and Parrot, 1980, Klages et al 1996 and Barranco et al, 2004), who have reported the formation of a water layer at a paint film-substrate boundary and associated this phenomenon with a reduction in adhesion to the substrate and greater levels of corrosion in oxidation.

4 Conclusions

This study was undertaken to understand whether the stability of a moisture sensitive active could be improved through application of moisture barrier coatings on tablet cores exhibiting low hygroscopicity. The moisture barrier coatings applied to tablet cores did not achieve a net reduction in the amount of moisture sorbed when exposed to elevated RH. The uncoated cores exhibited lower overall levels of aspirin degradation compared with coated samples. The use of current moisture barrier coatings on tablet cores with minimal water uptake characteristics does not appear to prevent the degradation of moisture sensitive actives.

References

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Ahlneck, C., Zografi, G. 1990. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int. J. Pharm. 62, 87-95.

Alvarez-Lorenzo, C., Gomez-Amoza, L., Martinez-Pacheco, R., Sonto, C., Cocheiro, A. 2000. Interactions between hydroxypropyl celluloses and vapour/liquid water. Eur. J. Pharm. Biopharm. 50 (2000) 307-318.

Barranco, V. Carpentier, J. Grundmeier G. 2004. Correlation of morphology and barrier properties of thin microwave plasma polymer films on metal substrates. Electrochim Acta 49, 1999-2013.

Buckton, G., Darcy, P. 1996. Water mobility in amorphous lactose below and close to the glass transition temperature, Int. J. Pharm. 136, 141–146.

Carstensen, J.T., 1988. Effect of moisture on the stability of solid dosage forms. Drug Dev. Ind. Pharm. 14, 1927-1969.

Dawoodbhai, S., Rhodes, C.T., 1989. The effect of moisture on powder flow and on compaction and physical stability of tablets. Drug Dev. Ind. Pharm. 15, 1577-1600.

Du, J., Hoag, S.W. 2001. The influence of excipients on the stability of the moisture sensitive drugs aspirin and niacinamide: comparison of tablets containing lactose monohydrate with tablets containing anhydrous lactose, Pharm. Dev. Technol. 6, 59–66.

Felton, L.A., McGinity. J. W. 1997. Influence of plasticizers on the adhesive properties of an acrylic resin copolymer to hydrophilic and hydrophobic tablet compacts. Int J Pharm 154, 167-178.

Fogel, J., Epstein, P., Chen, P. 1984. Simultaneous high-performance liquid chromatography assay of acetylsalicylic acid and salicylic acid in film-coated aspirin tablets. J Chromatog A 327, 507-511.

Fung, R.M., Parrot E.L. 1980. Measurement of film-coating adhesiveness. J Pharm Sci 69, 439-441.

Klages, C.P., Dietz, A, Höing, T. Thyen, R., Webber, A, Willich, P. 1996. Deposition and properties of carbon-based amorphous protective coatings. Surf Coat Technol 80, 121-128.

Landín, M., Perezmarcos, B., Casalderrey, M., Martinez-Pacheco, R., Gomez-Amoza, J.L., Souto, C., Concheiro A., Rowe, R.C. 1994. Chemical-stability of acetylsalicylic-acid in tablets prepared with different commercial brands of dicalcium phosphate dihydrate, Int. J. Pharm. 107, 247–249.

Lee, S., De Kay, H.E. Banker, G.S. 1966. Effect of water vapour pressure on moisture sorption and stability of aspirin and ascorbic acid in tablet matrices. J. Pharm. Sci. 54, 1153-1158.

Maulding, H.V., Zoglio, M.A., 1969. Pharmaceutical heterogeneous system: IV. A kinetic approach to the stability screening of solid dosage forms containing aspirin. J. Pharm. Sci. 58, 1359–1362.

Mwesigwa, E., Basit, A.W, Buckton, G. 2008. Moisture sorption and permeability characteristics of polymer films: Implications for their use as barrier coatings for solid dosage forms containing hydrolysable drug substances, J. Pharm. Sci. 97, 4433-4445.

Mwesigwa, E., Buckton, G., Basit, A.W 2005. The hygroscopicity of moisture barrier film coatings, Drug Devt. Ind. Pharm. 10 959-968.

Okhamafe, A.O., York, P. 1985. The adhesion characteristics of some pigmented and unpigmented aqueous-based film coatings applied to aspirin tablets. J Pharm Pharmacol 37, 849-853.

Zografi, G. 1988. States of water associated with solids. Drug Dev. Ind. Pharm. 14, 1905-1919.

Zografi, G., Kontny, M.J., 1986. The interaction of water with cellulose and starch-derived pharmaceutical excipients. Pharm. Res. 3, 187-194.

Beating Burnout: A Practical Guide for Pharmaceutical Scientists

October 30, 2021

Unrealistic pressures to perform and deliver results are creating burnout among many career scientists. If not adressed, work-related chronic reduces productivity, mental health deterioration.

At the last summer Olympics in Tokyo, Simone Biles, the four-time Olympic champion, stunned and also won applaud when she announced her withdrawal from the gymnastic team final and women’s individual finals to focus on her mental health.

For most of us engrossed in the world of chemicals and drug substances, the pommel horse is as far away as it gets, yet we can easily relate with the daily struggles of work, very much like Ms Biles. We may hate Mondays, find it hard to get motivated for even the smallest tasks, we often feel like we’ve lost skills, and the career that excited us and brought so much happiness is no more! Some of us have even contemplated leaving the field altogether, or even worse.

According to recent studies, these feelings are very common. It is just that among scientists, the rates of mental health are higher than those in the general public. In some reports, one in three PhDs is at risk of developing a mental-health disorder, including depression.

Many mental health problems are driven, in part, by the immense pressure on scientists to win funding, publish work in reputable periodicals, land jobs or create innovations in an unforgivingly competitive environment, where tolerance for failure is low. And COVID-19 has not helped matters.

To cap it all, studies have identified that scientists have poor mentorship, poor access to counselling services and those in their line management lack the training to manage wellbeing. This is why universities and employers are now being urged to improve mental health support services, revise leave-of-absence policies, and provide mentorship training all those in line management roles.

In this article, I describe burnout, a common cause of mental health deterioration among working professionals. I describe its causes and risk factors and how it can be prevented. Finally, I outline practical steps on how to recover if you have work-related stress.

What is burnout?

Burnout or chronic work-related stress, is a condition characterised by exhaustion. According the World Health Organisation, burnout is a syndrome arising from chronic workplace stress that has not been successfully managed. It is characterized by three dimensions:

  • feelings of energy depletion or exhaustion;
  • increased mental distance from one’s job, or feelings of negativism or cynicism related to one’s job; and
  • reduced professional efficacy.

Three of the world’s experts on burnout, Susan Jackson, Christina Maslach and Michael Leiter, all agree that burn-out is an occupational phenomenon, specifically defining as a psychological response to interpersonal stressors of work. It is different and apart from experiences in other areas of life.

It is important to mention that work-related stress is not an official medical condition in itself, it is usually only a symptom of other underlying issues, such as depression.

The sinister thing about burnout is that it may even go unnoticed and sufferers may not even be aware that the source of burn-out is their job!

Suffice to say burn-out, whether formally diagnosed or not, has the ability to impact both mental and physical health. And for this reason, it is important that burnout is recognised early and a plan put in place to help one recover from it.

How to tell if you have work-related stress

According to psychologist Susan Maslach, burnout manifests in the form of three symptoms, namely exhaustion, cynicism and inefficacy due to chronic stressors at work.

Exhaustion is the main symptom of burnout. It encompasses deep emotional exhaustion, physically, cognitively and emotionally, leading to an individual’s inability to function.

Cynicism or depersonalisation refers to a loss of connection and engagement with one’s work. Essentially, the sufferer of chronic burnout feels mentally removed from work, including colleagues, customers or assignments.

Inefficacy refers to feelings of failure and a lack of sense of accomplishment or productivity. Individuals who experience inefficacy feel their skills are eroding and may worry that they will not be successful in other areas of work.

The signs or symptoms can be physical, psychological and behavioural:

Physical symptoms include:

  • Fatigue
  • Muscular tension
  • Headaches
  • Heart palpitations
  • Sleeping difficulties, such as insomnia
  • Gastrointestinal upsets, such as diarrhoea or constipation
  • Dermatological disorders.

Psychological symptoms include:

  • Depression
  • Anxiety
  • Discouragement
  • Irritability
  • Pessimism
  • Feelings of being overwhelmed and unable to cope
  • Cognitive difficulties, such as a reduced ability to concentrate or make decisions.

Behavioural symptoms include:

  • An increase in sick days or absenteeism
  • Aggression
  • Diminished creativity and initiative
  • A drop in work performance
  • Problems with interpersonal relationships
  • Mood swings and irritability
  • Lower tolerance of frustration and impatience
  • Disinterest
  • Isolation.

Questions to ask yourself:

  • Do you constantly feel like you do not have energy for anything?
  • Is your sleep interrupted? For instance, do you sleep during the whole day or have problems falling or staying asleep?
  • Do you feel like you have to force yourself to go into work? Do you struggle to get started with work tasks?
  • Do you notice that you are easily irritated or impatient with work colleagues, clients or customers?
  • Have you become particularly critical or cynical about your work or others at work?
  • Do you feel you’re not as productive as you were in the past? Are you struggling to focus on your work?
  • Do you feel you no longer take interest in your achievements? Has your passion for the job gone?
  • Are you increasingly binge-eating to feel better? Are you using alcohol or drug to improve your mood?
  • Do you frequently suffer from headaches, unexplained stomach problems or any other unexplained pains or twitches?

Note that the mere fact that you answered yes to any of these questions, it does not necessarily mean you have work-related stress. Equally, you shouldn’t have to live with any of these feelings. Seeking help from professionals will help you deal with it early enough so that you can regain your mojo back and start living life to its fullness.

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Common causes of burnout

Chronic work-related stress is a growing concern in the workplace around the world. Health experts attribute the rise in burnout to increase in work demands and lack of awareness on practical ways to manage it.

All the following issues have been identified as potential stressors at workplaces. A risk management approach will identify which ones exist in your own workplace and what causes them. They include:

  • Organisation culture
  • Bad management practices
  • Job content and demands
  • Physical work environment
  • Relationships at work
  • Change management
  • Lack of support
  • Role conflict

If a job saps a lot of energy and exposes you constantly to stress, for instance the pressure to meet very tight deadlines, absence of social and supportive network or if the job is chaotic or monotonous, the chances of experiencing burnout are much higher.

Some of the factors that commonly cause burnout include:

  • Long hours
  • Heavy workload
  • Changes within the organisation
  • Tight deadlines
  • Changes to duties
  • Job insecurity
  • Lack of autonomy
  • Boring work
  • Insufficient skills for the job
  • Over-supervision
  • Inadequate working environment
  • Lack of proper resources
  • Lack of equipment
  • Few promotional opportunities
  • Harassment
  • Discrimination
  • Poor relationships with colleagues or bosses
  • Crisis incidents, such as an workplace death
  • Unclear expectations

How to prevent or handle early stages of burnout

Thanks to ongoing research by psychologists and health professionals, our understanding of causes and solutions for burnout is much improved. We have a better understanding of what to do once the symptoms of burnout are picked up.

So here are some strategies that have been successful across the board:

  1. Focus on self-care and wellbeing

It’s crucial to refill your physical and emotional energy, as well as your ability to focus by prioritising sleep hygiene, nutrition, exercise, social networks, and practices that promote mental calmness, such as meditation, journaling and nature appreciation.

If for one reason or another you find it difficult to squeeze in these activities in your schedule, take a week to examine how you spend your time.

You can then take a look at each block of time in your day and record how you spend time, i.e., what you do, the people you spend the time with and how you feel. Then score each activity in terms of how valuable it is or how it leaves you (1 = drained, 10 = energised).

This can enable you find breaks and opportunities to reduce exposure to situations that do not build you, and this way, find breaks for rejuvenating moments away from work.

  1. Shift your outlook

Although relaxation, resting and rejuvenation can help alleviate exhaustion, address cynicism and improve productivity, they do little as far as mollifying the underlying causes of burnout.

Back at work, you may still have to contend with the same unmanageable workload, conflicts or lack of resources. It is therefore important to take a look at your expectations with respect to work:

Which aspects of work can be changed? It helps to ask yourself what tasks can be delegated to free up energy for other meaningful tasks. Perhaps some aspects of your work could be changed to allow you regain some level of control over your workday.

And if it is cynicism, look into ways of sheltering yourself from parts of the workplace that antagonise or frustrate you and instead re-engage with those aspects of the job that are most meaningful.

It also greatly helps if you can find supportive relationships and networks that can help counteract those that drain you.

  1. Eliminate or reduce exposure to stressors

Reduction of job stressors requires you to recognize those particular activities and relationships that trigger unhealthy stress. This might require a reset of expectations from colleagues, clients and even family members regarding what and how much you are willing to take on as well as the ground rules for walking together.

You may, of course, experience resistance as you go about this; the most important thing, however, is to assure yourself that the changes you’re making will improve your long-term productivity as well as protecting your wellbeing.

  1. Invest in connectivity

It has been found that one of the most effective remedies for burnout, especially when its driven by cynicism and inefficacy, are finding and making rewarding interpersonal connections and seeking professional growth. Reaching out to and engaging in coaching and with suitable mentors that can help identify opportunities for growth can be highly rewarding.

Another issue is finding opportunities to volunteer in your community or to help others in similar situations can be a very powerful way to break out of a negative cycle of cynicism and lack of motivation.

Finally, given the role of the situational dimension to burnout, chances are that others in your organisation have burnout, too. So finding and identifying with others in a similar predicament will help identify organisation-wide problems and lasting ways to address them.

  1. Nip burnout in the bud

Getting aware of the problem is the first step to addressing burnout. However, this is often the most difficult simply because we tend not to accept ‘weakness’ or reassess aspects of our behaviour.

If you hear family or colleagues express any concerns about your work, its important to take heed. Granted, accepting that you are heading into a crisis will be hard to take, however, and at the end of the day, your wellbeing is what counts.

  1. Get support

It is crucial to find someone who is willing to challenge your assumptions and give you a different take on things. This may be a trusty friend, a coach, family member or therapist. This is because burnout has the potential to cloud your thinking and decision making. Hence, if you can be helped with finding and mapping out work-life boundaries, it will be easier to to find that happy medium.

  1. Take time to recharge even if you love your job very much

It’s common to get exhausted from time to time, particularly on those occasions when the job is all consuming. This is not full burnout. Still, it is important not to let things slip, so here are some quick ways to recharge:

Take breaks during the day. In order to perform at your best consistently, you need to find opportunities to restock your mental energy. Taking regular breaks allows to step away and clear your headspace.

Put away digital devices for a moment. Today, we find ourselves carrying our offices wherever we go with no downtime at all. It is a good practice to place your work phone away when you arrive home so that you’re not tempted to check work emails during out of office hours.

Take weekend breaks. Short breaks have been shown to help reduce stress, aid with maintain peak performance while also reducing the need for long lay-offs. Make sure that while you’re away, you completely switch off from work.

How to recover if you already have burnout

The first step to take in order to recover from burnout is to regain your perception of control of your situation first. During the state of burnout, people often feel as if their circumstances are out of their grasp, a few others may even feel the rest of the world is working against their interests. This mentality creates a virtuous cycle and block them from dealing with their circumstances.

But what is resilience? Simply it is an individual’s ability to positively respond to stress, pressure, risk and adversity.

To fully appreciate resilience, we need to borrow from the British Army’s highly acclaimed mental resilience programme for its soldiers. This programme recognises soldiers do not only need physical strength but also mental toughness if they are to effectively face the many challenges of their careers. It comprises the following principles:

SELF-BELIEF – confidence in your own abilities and judgement

POSITIVE AFFECT – the ability to interact with life in a positive way

EMOTIONAL CONTROL – the ability to understand and express your emotions

MENTAL CONTROL – the ability to control thinking, attention, concentration, focus, self-awareness, reflexivity, problem-solving

SENSE OF PURPOSE – the motivation that drives you forward

COPING – adaptability, natural coping strategies you have learnt through coping in previous stressful situation

SOCIAL SUPPORT – the social network you have and the ways you use it.

Here are some of the things you can do to build mental toughness:

1. Develop a positive mindset

To increase your resilience, the first thing that one has to do is refocus on building a strong, positive mindset in everyday life.

2. Know your why

Another aspect of building resilience is constantly being aware of your “why” when it comes to your short and long-term goals. If you’re going to achieve a big goal knowing why you need to do it in the first place cushions you against discouragements and disengagements as soon as you experience your first setback.

3. Find strength in others

Developing resilience is much about your inner fortitude as much as embracing the idea that you’re not in it alone. Even the most successful people among us rely and count on others for support, mentorship, guidance and encouragement when times are difficult. So you should have the confidence to do the same.

4. Learn to pick yourself up

Finally, it is worth remembering that building resilience isn’t easy! Anyone who’s ever achieved massive success knows that obstacles, setbacks, and failure are inevitable, and you’re no different.

As you work on your goals, you’re going to face many ups and downs, but this doesn’t mean that you don’t have mental toughness, willpower, or discipline.

In summary, you can build resilience through learning to recognize negative tendencies and taking action to correct them early on with healthy habits. Developing resilience is not about eliminating weakness, but learning how to deal with it and overcome it.

Final Thoughts on Burnout

The never-ending pressures to deliver new knowledge and products and be on top of things have undesirable consequences for scientists’ wellbeing. Burnout, the term that is sometimes used for all sorts of work-related stresses, is, in realty a serious red-flag that things are not going well. Unmanaged, chronic burnout leads to low productivity, negative emotions and mental ill-health. Recognising burnout early and taking steps to deal with its causes is important. But equally, all stakeholders, from line managers, to the boardroom, need to understand and recognise burnout and institute processes to address it so that workplaces are supportive and more productive.

Reference
  • Diane Wood. Corporate burnout affecting the mental health of 20% of top performers in uk businesses. Personnel today, may 3, 2017.
  • Christina Maslach and Susan E Jackson. The Measurement of Experienced Burnout. Journal of Occupational Behaviour 2 (1981): 99-113.

Opinion | What Does the Recent Pig-to-Human Kidney Transplant Mean for Tissue Therapeutics?

October 29, 2021

In a pioneering procedure, a team of surgeons at New York University Langone Health Grossman School of Medicine in New York City managed to attach a pig kidney to a human patient. The kidney functioned normally for 54 hours.

Last week, a team of surgeons in New York City were to able to successfully attach a pig kidney to a human patient and watch the organ function normally for a whole 54 hours. While procedures of this kind are not new in nonhuman primates, it is the first time that a pig kidney has been transplanted into humans and not been immediately rejected.

The process of transplanting living cells, tissues or organs from one species into another is what scientists call xenotransplantation. However, owing to genetic differences between species, past xenotransplantation efforts have not been successful, leading to immediate organ rejection by the human immune system.

The breakthrough procedure, which was announced at a news conference and widely reported in the media on October 21, represents a giant step towards the aim of increasing availability of life-saving organs for transplantation. Waiting list for donated organs around the world are in the millions, and demand is not expected to drop anytime soon despite a rise in organ donation registrations.

Speaking on condition of anonymity, a nephrologist at Abbott Northwestern Hospital, Minneapolis, MN said the fact that transplant survived three days with full function and no signs of rejection was an “incredible achievement,” and gives fresh confidence that “patients will have access to additional sources of organ for transplantation in the near future”.

However, several years of more of research, clinical trials and regulatory scrutiny are required before we can start to see pig kidneys on surgical tables.

In a press release, Robert Montgomery, MD and chair of the department of surgery at NYU Langone and director of the NYU Langone Transplant Institute, noted that the future of this work is not limited to kidneys.

“Transplanting hearts from a genetically engineered pig may be the next big milestone,” he said. “This is an extraordinary moment that should be celebrated — not as the end of the road, but the beginning. There is more work to do to make xenotransplantation an everyday reality.”

Why pigs?

In the quest to address the chronic shortage of organs, scientists have long sought the use animal organs. Pigs have emerged as an interesting choice because their organs are anatomically similar to those of humans, and they can be easily bred in a highly controlled manner.

However, it is more that ease of breeding. In the mid-20th century, xenotransplantation scientists noticed that transplanted animal organs quickly turned black, a phenomenon known as hyperacute rejection.

As knowledge has improved, scientists have been able to use genetic engineering to overcome some of these challenges. For example, it was found that aggressive immune responses seen after a pig xenotransplant was due to antibodies detecting alpha-gal, a sugar moiety found on porcine vasculature.

Disabling the gene that codes for alpha-gal was key to addressing hyperacute rejection of pig organs. Until now, a test of this sort of transplant hadn’t been done successfully in humans.

So what did the New York University Langone Health team do?

In order to overcome the many ethical hurdles of performing such an operations in humans the surgical team approached the family of a woman with brain stem death kept alive on a ventilator. Although the woman was an organ donor, her organs were not suitable for donation.

Over a period of several hours, the surgical team worked to attach the pig kidney, which had been genetically engineered to remove the alpha-gal sugar to blood vessels, in the upper leg of the patient. The kidney was kept outside of the body so the team could assess its function in real time.

In order to improve chances of acceptance, the team also transplanted the animal’s thymus gland, which aids the education of the immune system to recognize the kidney as part of the body. The patient was also given specific drugs that suppress the immune system.

Within minutes, the kidney started producing large amounts of urine and showed other signs of normal functioning. The pig kidney functioned just like a human kidney transplant. The research team stopped monitoring at 54 hours in line with IRB ethical guidance.

The patient was taken off life support after the procedure.

What’s next for these sort of transplants?

To survive 54 hours represents a significant development but to become mainstream, animal kidneys will need to survive for years not days. For this to happen, researchers will need to show that these organs can withstand immune system attacks for years in the human body.

A key aspect of this journal is to show that transplants are safe in the long-term and obtain approval from health authorities, including the U.S. FDA and the European Medicines Agency.

Are there any ethical concerns about breeding pigs for organ harvesting?

Using any animal for the sole benefit of humans raises important ethical questions. Advocates for xenotransplantation argue the potential benefits of expanding the organ supply are worth any potential harm done to animals.

The jury is still out on how acceptable the idea of breeding millions of pigs in order to harvest organs for human transplantation is.

PETA (People for the Ethical Treatment of Animals), a campaigning organisation against the use of animals in research, contests the whole idea that we should consign animals as sources of spare parts for humans (see their statement through this link).

Questions or comments on this article? E-mail us at editor@pharmacentral.com.

Sources

NYU Langone Health. Progress in xenotransplantation opens door to new supply of critically needed organs. Published online October 21, 2021.

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