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Maltitol Solution Excipient | Uses, Suppliers, and Specifications
Maltitol Solution (or Liquid Maltitol) is an aqueous syrupy liquid containing, on an anhydrous basis, 50% w/w of D-Maltitol (C12H24O11) and 8.0% w/w of Sorbitol (C5H1406). Excipient-grade Maltitol solution is supplied as a colourless and odourless, viscous and sweet-tasting (approximately 75% the sweetness of sucrose) liquid.
Pharmacopoeial Compliance: USP-NF; Ph.Eur; J.P, B.P
Synonyms and Trade Names: Liquid Maltitol; Maltitol Solution; Maltitol Syrup; Hydrogenated Glucose Syrup; Maltitol, Liquid; Hydrogenated Starch Hydrolysate; E965; Finmalt® L; Lycasin® HBC; Lycasin® 8055; Maltisorb® 7575; Maltisweet® 3145; Maltilite®5575; C☆Pharm™ Maltidex L Maltitol Solution
Uses and Applications: Suspending Agent, Sweetener, and Coating Agent
Description
Maltitol solution is an aqueous solution of a hydrogenated, partly hydrolysed starch. It is composed of a mixture of mainly 4-O-α-D-glucopyranosyl-D-glucitol (Maltitol), D-glucitol (Sorbitol) and hydrogenated oligo- and polysaccharides. The total solids content is 68% – 85% w/v, of which ≥50% w/w is Maltitol. The amount of Sorbitol is 8% w/w, with the rest being contributed to by miscellaneous hydrogenated oligo- and polysaccharides. In the USP-NF, Maltitol solution is defined as an aqueous solution containing, on an anhydrous basis, not less than 50% w/w of D-Maltitol (C12H24O11) and not more than 8.0% w/w of D-Sorbitol.
Maltitol solution is prepared by the hydrogenation of a high-Maltose syrup that is obtained from starch by enzymatic hydrolysis. The maltitol solution produced from this process consists of the hydrogenated homologs of the oligosaccharides contained in the original syrup. It is for this reason that Maltitol solution is sometimes known as Hydrogenated starch hydrolysate or Hydrogenated glucose syrup, which are generic terms used to describe aqueous mixtures containing mainly D-Maltitol, plus Sorbitol and hydrogenated oligosaccharides and polysaccharides. However, such mixtures exhibit wide variations in composition and physicochemical properties. In the pharmaceutical field, more specific terminology of Maltitol solution is preferred for products containing up to 90% of Maltitol.
Pharmaceutical excipient-grade Liquid maltitol is supplied as a colourless and odourless, clear viscous and sweet-tasting (approximately 75% the sweetness of sucrose) aqueous liquid.
Chemical Structure & Identifiers
| Chemical Name | 4-O-α-D-Glucopyranosyl-D-glucitol |
| CAS Registration Number | [68425-17-2]
[585-88-6] |
| Empirical Formula | C20H40O4 |
| Molecular weight | 344.32 |
| EC Number | 270-337-8 |
| US FDA UNII Code | 27F77DSJ5V |
Regulatory Status
Physicochemical Properties
| Form | Liquid |
| Appearance | Colorless, clear viscous liquid |
| Boiling point | 105oC |
| Flash point | >1500C |
| Density | 1.36 g/ml at 20oC |
| Heat of combustion | 10.0kJ/g (2.4cal/g) |
| Osmolarity | Similar to that of a sucrose solution of the same concentration |
| Solubility | Miscible with water, ethanol (ethanol concentration should not exceed 55%), glycerin and propylene glycol. Insoluble in mineral and vegetable oils. |
| Viscosity (Brookfield) at 200C | Maltitol solution is a viscous, syrupy liquid. A solution of Lycasin 80/55 (Roquette) containing 75% of dry substances has a viscosity of 2000 cP |
Pharmacopeoeal Specifications
| USP-NF | Ph.Eur | |
| Official name | Maltitol Solution | Maltitol, Liquid |
| Authorised use | Excipient | Excipient |
| Definition | specified | specified |
| Identification | A, B | A, B, C |
| Characters | n/a | specified |
| Appearance of solution | n/a | specified |
| Conductivity | n/a | ≤ 10µS.cm |
| pH | 5.0-7.5 | n/a |
| Reducing sugars | ≤ 0.3% | ≤ 0.2% |
| Lead | n/a | ≤ 0.5 ppm |
| Nickel | ≤ 1 ppm | ≤ 1 ppm |
| Water | ≤ 31.5% | 15.0-32.0% |
| Residue on ignition | ≤ 0.1% | n/a |
| Assay Maltitol (dried basis) | ≥ 50.0% | ≥ 50.0% |
| Assay Sorbitol (dried basis) | ≤ 8.0% | ≤ 8.0% |
| Microbial contamination
Aerobic bacteria Fungi |
≤ 1000 cfu/g ≤ 100 cfu/g |
≤ 1000 cfu/g ≤ 100 cfu/g |
| Labelling | n/a | specified |
Key: n/a Specification is not listed
*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.
Applications in Pharmaceutical Formulations or Technology
Maltitol solution is a pharmaceutical excipient commonly used as a suspending and sweetening agent in liquid and some solid oral preparations. It is also suitable for use in oral pharmaceutical formulations as a bulk sweetening agent, either alone or in combination with other excipients, such as Sorbitol (added during the wet granulation step).
A key application of Maltitol solution is as a suspending agent in oral suspensions as an alternative to Sucrose or glucose syrup due to its favourable viscosity, noncariogenic, and low calorific properties. Being non-crystallising (prevents ‘cap-locking’ in syrups) is additionally advantageous.
Finally, Maltitol solution is used to formulate lozenges, soft chewing gums and gummies.
Safety and Precautions
Maltitol solution is currently used in oral liquid pharmaceutical formulations and in food products (baked goods, chocolates, and many other food products). It is a nontoxic, nonallergenic, and nonirritant material, is widely considered noncariogenic, and may be suitable for use in diabetic individuals, subject to medical supervision.
The European Union Scientific Committee on Food has reviewed the safety of Maltitol solutions and noted the availability of adequate data on the safety of the product (acute toxicity, subchronic toxicity in two species, a large number of mutagenicity tests, metabolic studies and several clinical tolerance studies). In addition, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) reviewed Maltitol syrup on several occasions. An ADI “not specified” was allocated since the levels used in food to achieve the desired effect were not considered a hazard to human health.
Toxicology: LD50 (rat, IP): 20g/kg
Even though safe for human consumption, consumption of Maltitol in excessive amounts can cause GI tract distress, bloating and diarrhoea. It is a legal requirement to include a label warning for products that contain Maltitol syrup.
Stability and Storage Conditions
Maltitol solution is stable for at least 24 months provided it is handled correctly (i.e stored at room temperature and pH 3 – 9). It is also noncrystallising. Storage at higher temperatures can result in changes depending on other pertinent conditions.
For instance, at 50 0C, Maltitol solution at pH 2 may undergo slight hydrolysis (around 1.2%) and turn yellow in colour after 90 days. At a slightly higher pH of 3, and under the same storage conditions, no colour change is observed although the material may still exhibit slight hydrolysis (0.2%). At pH 4-9, no hydrolysis occurs although a very slight yellow colour may develop.
To avert spoilage, formulations that contain Maltitol solution should be adequately preserved (for instance, with Potassium benzoate or a mixture of Methylparaben and Propylparaben).
When handling Maltitol solution, observe applicable SHEQ protocols appropriate to the circumstances and quantity of material processed.
Sustainability and Environmental Impact
A sustainability score for Maltitol solution has not been undertaken. However, as this substance is sourced from natural, biodegradable and sustainable feed material (Starch), we do not consider its impact on the environment and marine ecology adverse.
Manufacturers & Suppliers
- Maltilite® 5575 Maltitol Solution
- LYCASIN® 7575 Maltitol Solution
- LYCASIN® 8055 Maltitol Solution
- LYCASIN® 8575 Maltitol Solution
- LYCASIN® HBC Maltitol Solution
- C☆Pharm™ Maltidex L Maltitol Solution
- C☆Pharm™ Maltidex M (higher maltitol content) Maltitol Solution
Additional Resources (Downloads)
References and Literature Used
FAQS
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