Chemical Properties
Trehalose occurs as virtually odorless, white or almost white
crystals with a sweet taste (approximately 45% of the sweetness of
sucrose).
Chemical Properties
white to off-white crystalline powder
Definition
ChEBI: A trehalose in which both glucose residues have alpha-configuration at the anomeric carbon.
Production Methods
Trehalose is prepared from liquefied starch by a multistep enzymatic
process. The commercial product is the dihydrate.
Flammability and Explosibility
Notclassified(100%)
Pharmaceutical Applications
Trehalose is used for the lyoprotection of therapeutic proteins,
particularly for parenteral administration. Other pharmaceutically
relevant applications include use as an excipient for diagnostic assay
tablets; for stabilization during the freeze–thaw and lyophilization
of liposomes; and for stabilization of blood cells,
cosmetics, and monoclonal antibodies. Trehalose may also be
used in formulations for topical application.
Safety
Trehalose is used in cosmetics, foods, and parenteral and
nonparenteral pharmaceutical formulations. It is generally regarded
as a relatively nontoxic and nonirritant material when used as an
excipient.
In the gut, trehalose is rapidly metabolized to glucose by the
specific enzyme trehalase. A small minority of the population
exhibits a primary (hereditary) or secondary (acquired) trehalase
deficiency and thus may experience intestinal discomfort after
ingestion of excessive amounts of trehalose owing to the osmotic
activity of undigested trehalose in the gut. However, smaller
amounts of trehalose are tolerated by such individuals without
any symptoms.
Trehalose is used as a sweetener and is reported to have
substantially less cariogenic potential than sucrose.
LD50 (dog, IV): >1 g/kg
LD50 (dog, oral): >5 g/kg
LD50 (mouse, IV): >1 g/kg
LD50 (mouse, oral): >5 g/kg
LD50 (rat, IV): >1 g/kg
LD50 (rat, oral): >5 g/kg
storage
Trehalose is a relatively stable material. At 60°C for 5 hours it loses
not more than 1.5% w/w of water (the dihydrate water of crystallization is retained). Open stored powder may liquefy at high
relative humidity (≥90%).
Trehalose should be stored in a cool, dry place in a well-sealed
container.
Incompatibilities
Trehalose is incompatible with strong oxidizing agents, especially in
the presence of heat.
Regulatory Status
GRAS listed. In the UK trehalose may be used in certain food
applications. Included in parenteral and nonparenteral investigational
formulations.
