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Lactitol
لاکتیتول
1Nonproprietary names
- BPLactitol Monohydrate
- Ph. Eur.Lactitol Monohydrate
- USP–NFLactitol
2Synonyms and trade names
Finlac DC; lactit; lactitol monohydrate; lactobiosit; lactositol; Lacty; E966
3Chemical name and CAS Registry Number
4-O-β-D-Galactopyranosyl-D-glucitol · [585-86-4]
UNII L2B0WJF7ZY · PubChem CID 157355
4Empirical formula and molecular weight
C12H24O11 (anhydrous); C12H24O11·H2O (monohydrate) · 344.31 (anhydrous); 362.34 (monohydrate)
5Functional category
Sweetening agent, Diluent (filler)
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
A sugar alcohol used as a sweetener and as a non-cariogenic diluent in tablets (direct-compression grades are available), chewable tablets, lozenges, sugar-free coatings and confectionery. Its sweetness is about 30–40% of that of sucrose, so it is often combined with intense sweeteners. As an active substance it is used as an osmotic laxative.
7Description
White, odourless, sweet-tasting crystals or crystalline powder. It exists in anhydrous, monohydrate and dihydrate forms; the monohydrate is the usual pharmaceutical form.
8Typical properties
- Sweetness
- about 0.3–0.4 times that of sucrose
- Solubility
- very soluble in water; slightly soluble in ethanol
- Hygroscopicity
- the monohydrate is practically non-hygroscopic at normal humidity
- Energy value
- about 2 kcal/g (reduced-calorie)
9Stability and storage conditions
Stable to heat and over a wide pH range. It is non-reducing, so it does not take part in Maillard browning. Store in a well-closed container in a dry place.
10Incompatibilities
No significant incompatibilities have been reported.
11Method of manufacture
Made by catalytic hydrogenation of lactose in aqueous solution, followed by purification and crystallisation.
12Safety
Poorly absorbed from the small intestine and fermented in the colon, so large amounts cause flatulence, abdominal discomfort and an osmotic laxative effect. It is non-cariogenic and produces only a small rise in blood glucose.
13Handling precautions
Observe normal precautions for the quantity handled; eye protection and a dust mask are recommended.
14Regulatory status
Accepted as a food additive in Europe (E966); foods containing more than 10% added polyols must carry a laxative-effect warning. Included in non-parenteral medicines licensed in Europe.
15Related substances
Isomalt; lactose; maltitol; mannitol; sorbitol; xylitol.
16Comments
Lactitol has a clean, sugar-like taste without the cooling effect of xylitol or sorbitol. Although it is made from lactose, it is not a reducing sugar and can be used with amine drugs that are incompatible with lactose.