Food additives Europe numbers: E965
Functional Category
Suspending agent; sweetening agent.
Applications in Pharmaceutical Formulation
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,(1) and is also used in confectionery and food products.
Description
Maltitol solution is a colorless and odorless, clear viscous liquid. It is sweet-tasting (approximately 75% the sweetness of sucrose).
Stability and Storage Conditions
Maltitol solution is stable for at least 2 years at room temperature and pH 3–9. Following storage for 3 months at 508C, 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.(2) 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.
Safety
Maltitol solution is used in oral pharmaceutical formulations, confectionery, and food products, and is considered to be less cariogenic than sucrose.(3–6) It is generally regarded as a nontoxic, nonallergenic, and nonirritant material. However, excessive oral consumption (more than 50 g 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.(7,8) LD50 (rat, IP): 20 g/kg(9)