Incompatibilities



A Maillard-type condensation reaction is likely to occur between lactose and compounds with a primary amine group to form brown, or yellow-brown-colored products.(18)

Lactose is also incompatible with amino acids, aminophyl- line,(19) amfetamines,(20) and lisinopril.(21)

Method of Manufacture

Lactose is a natural disaccharide consisting of galactose and glucose and is present in the milk of most mammals. Commercially, lactose is produced from the whey of cows’

Tablettose 100 0.54 0.74 5.2

Tablettose 80 0.57 0.72 5.2

Tablettose 70 0.51 0.62 —

Inhalac 70 0.60 0.66 5.2

Inhalac 120 0.68 0.78 5.2

Inhalac 230 0.69 0.80 5.2

Quest International Inc. (Sheffield Products)

lactose; lactose constitutes 38% of the total solid content of milk.

a-Lactose monohydrate is prepared by crystallization from supersaturated solutions below 93.58C. Various crystalline shapes are prism, pyramidal, and tomahawk; these are dependent on the method of precipitation and crystallization. Direct compression grades of a-lactose monohydrate are

Lactose Monohydrate NF

80M

Lactose Monohydrate NF Capsulating Grade Lactose Monohydrate NF

Impalpable

— — 4.5–5.5

— — 4.5–5.5

— — 4.5–5.5

prepared by granulation/agglomeration and spray-drying.