Lactose, Spray-Dried

Synonyms: FlowLac 90; FlowLac 100; Lactopress Spray-Dried; Lactopress Spray-Dried 250; NF Lactose–315; NF Lactose–316 Fast Flo; SuperTab 11SD; SuperTab 14SD

Description: Lactose occurs as white to off-white crystalline particles or powder. It is odorless and slightly sweet-tasting. Spray-dried directcompression grades of lactose are generally composed of 80–90% specially prepared pure a-lactose monohydrate along with 10–20% of amorphous lactose

Chemical Name: Spray-dried lactose is a mixture of amorphous lactose, which is a 1 : 1 mixture of a-and-b-lactose, and O-b-D-galactopyranosyl- (1!4)-a-D-glucopyranose monohydrate

Tablet and Capsule Diluent  Directly compressible tablet excipient; tablet and capsule filler

• Spray-dried lactose is widely used as a binder, filler-binder, and flow aid in direct compression tableting.

Lactose is a reducing sugar. The amorphous lactose, which is the most reactive form of lactose present in spray-dried lactose, will interact more readily than conventional crystalline grades. Typical reactions include the Maillard reaction with either primary or secondary amines.

Lactose is widely used in pharmaceutical formulations as a diluent 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 enzyme lactase.

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

Lactose, anhydrous; lactose, inhalation; lactose, monohydrate.