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.
LD
50 (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.
