Lycasin

Chemical properties

Maltitol solution is a colorless and odorless, clear viscous liquid. It is sweet-tasting (approximately 75% the sweetness of sucrose).

Production Methods

Maltitol solution is prepared by the hydrogenation of a highmaltose 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.

Pharmaceutical Applications

Maltitol solution is used in oral pharmaceutical formulations as a bulk sweetening agent, either alone or in combination with other excipients, such as sorbitol. Maltitol solution is also used as a suspending agent in oral suspensions as an alternative to sucrose syrup since it is viscous, noncariogenic, and has a low calorific value. It is also noncrystallizing and therefore prevents ‘cap-locking’ in syrups and elixirs.
Maltitol solution is additionally used in the preparation of pharmaceutical lozenges,and is also used in confectionery and food products.

Safety

Maltitol solution is used in oral pharmaceutical formulations, confectionery, and food products, and is considered to be less cariogenic than sucrose.It is generally regarded as a nontoxic, nonallergenic, and nonirritant material. However, excessive oral consumption (more than 50g daily) may cause flatulence and diarrhea.
The WHO, in considering the safety of maltitol solution, did not set a value for the acceptable daily intake since the levels used in food to achieve a desired effect were not considered a hazard to health.
LD₅₀ (rat, IP): 20 g/kg

Storage

Maltitol solution is stable for at least 2 years at room temperature and pH 3–9. Following storage for 3 months at 50°C, maltitol solution at pH 2 underwent slight hydrolysis (1.2%) and became yellow colored. At pH 3, and the same storage conditions, no color change was apparent although very slight hydrolysis occurred (0.2%). At pH 4–9, no hydrolysis occurred although a very slight yellow color was formed under alkaline conditions.
Formulations containing maltitol solution should be preserved with an antimicrobial preservative such as sodium benzoate or a mixture of parabens. Maltitol solution is noncrystallizing.
Maltitol solution should be stored in a well-closed container, in a cool, dry place.

Regulatory Status

Accepted for use in confectionery, foods, and nonparenteral pharmaceutical formulations in Europe and the USA. Included in the Canadian List of Acceptable Non-medicinal Ingredients.