Лактитол

Химические свойства

Lactitol occurs as white orthorhombic crystals. It is odorless with a sweet taste that imparts a cooling sensation. It is available in powdered form and in a range of crystal sizes. The directly compressible form is a water-granulated product of microcrystalline aggregates.

Использование

Lactitol is listed as an excipient in some prescription drugs, such as Adderall. Lactitol is a sugar alcohol used as a replacement bulk sweetener for low calorie foods. It is also used medically as a laxative.

Методы производства

Lactitol is produced by the catalytic hydrogenation of lactose.

Фармацевтические приложения

Lactitol is used as a noncariogenic replacement for sucrose. It is also used as a diluent in solid dosage forms.(1) A direct-compression form is available,(2,3) as is a direct-compression blend of lactose and lactitol. Lactitol is also used therapeutically in the treatment of hepatic encephalopathy and as a laxative.

Безопасность

Lactitol is regarded as a nontoxic and nonirritant substance. It is not fermented significantly in the mouth, and is not cariogenic.It is not absorbed in the small intestine, but is broken down by microflora in the large intestine, and is metabolized independently of insulin. In large doses it has a laxative effect; therapeutically, 10–20 g daily in a single oral dose is administered for this purpose.
LD50 (mouse, oral): >23 g/kg
LD50 (rat, oral): 30 g/kg

хранилище

Lactitol as the monohydrate is nonhygroscopic and is stable under humid conditions. It is stable to heat and does not take part in the Maillard reaction. In acidic solution, lactitol slowly hydrolyzes to sorbitol and galactose. Lactitol is very resistant to microbiological breakdown and fermentation. Store in a well-closed container. When the compound is stored in an unopened container at 25°C and 60% relative humidity, a shelf-life in excess of 3 years is appropriate.

Регуляторный статус

GRAS listed. Accepted for use as a food additive in Europe. Included in the Canadian List of Acceptable Non-medicinal Ingredients.