Lactose, Anhydrous

Synonyms:  Anhydrous 60M; Anhydrous Direct Tableting (DT); Anhydrous DT High Velocity; Anhydrous Impalpable; Lactopress Anhydrous; Lactopress Anhydrous 250; lactosum anhydricum; lattosio; milk sugar; SuperTab 21AN; SuperTab 22AN; saccharum lactis.

Description:  Anhydrous lactose occurs as white to off-white crystalline particles or powder. Several different brands of anhydrous lactose are commercially available which contain anhydrous b-lactose and anhydrous a-lactose. Anhydrous lactose typically contains 70–80% anhydrous b-lactose and 20–30% anhydrous a-lactose.

Chemical Name: O-b-D-Galactopyranosyl-(1!4)-b-D-glucopyranose

Directly compressible tablet excipient; dry powder inhaler carrier; lyophilization aid; tablet and capsule diluent; tablet and capsule filler

• Anhydrous lactose is widely used in direct compression tableting applications, and as a tablet and capsule filler and binder.

• Anhydrous lactose can be used with moisture-sensitive drugs due to its low moisture content.

• It may also be used in intravenous injections.

Lactose anhydrous is incompatible with strong oxidizers. When mixtures containing a hydrophobic leukotriene antagonist and anhydrous lactose or lactose monohydrate were stored for six weeks at 40C and 75% RH, the mixture containing anhydrous lactose showed greater moisture uptake and drug degradation.

Lactose is widely used in pharmaceutical formulations as a diluent and filler-binder in oral capsule and tablet formulations. It may also be used in intravenous injections. Adverse reactions to lactose are largely due to lactose intolerance, which occurs in individuals with a deficiency of the intestinal enzyme lactase, and is associated with oral ingestion of amounts well over those found in solid dosage forms.

Observe normal precautions appropriate to the circumstances and quantity of materials handled. Excessive generation of dust, or inhalation of dust, should be avoided.

Lactose, inhalation; lactose, monohydrate; lactose, spray-dried.