General Description
White hard crystalline powder.
Reactivity Profile
Flammable and/or toxic gases are generated by the combination of alcohols with alkali metals, nitrides, and strong reducing agents. They react with oxoacids and carboxylic acids to form esters plus water. Oxidizing agents convert them to aldehydes or ketones. Alcohols exhibit both weak acid and weak base behavior. They may initiate the polymerization of isocyanates and epoxides.
Air & Water Reactions
Water soluble.
Health Hazard
ACUTE/CHRONIC HAZARDS: This chemical should be considered toxic.
Chemical Properties
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 Properties
white crystals or powder
Definition
A sugar found in milk. It is a disaccharide
composed of glucose and galactose units.
Production Methods
There are two anhydrous forms of lactose: a-lactose and b-lactose.
The temperature of crystallization influences the ratio of a- and blactose.
The anhydrous forms that are commercially available may
exhibit hygroscopicity at high relative humidities. Anhydrous
lactose is produced by roller drying a solution of lactose above
93.5°C. The resulting product is then milled and sieved. Two
anhydrous a-lactoses can be prepared using special drying
techniques: one is unstable and hygroscopic; the other exhibits
good compaction properties. However, these materials are not
commercially available.
Pharmaceutical Applications
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.
Safety
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.
storage
Mold growth may occur under humid conditions (80% RH and
above). Lactose may develop a brown coloration on storage, the
reaction being accelerated by warm, damp conditions. At 80°C and 80% RH, tablets containing anhydrous lactose
have been shown to expand 1.2 times after one day.
Lactose anhydrous should be stored in a well-closed container in
a cool, dry place.
Purification Methods
-Lactose crystallises from water below 93.5o as the hydrate which can be dried at 80o/14mm. [Horst Recl Trav Chim, Pays-Bas 72 878 1953, Beilst 17 III/IV 3066.]
Incompatibilities
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 40°C and 75% RH, the mixture containing anhydrous
lactose showed greater moisture uptake and drug degradation.
Studies have also shown that in blends of roxifiban acetate
(DMP-754) and lactose anhydrous, the presence of lactose
anhydrous accelerated the hydrolysis of the ester and amidine
groups.
Lactose anhydrous is a reducing sugar with the potential to
interact with primary and secondary amines (Maillard reaction)
when stored under conditions of high humidity for extended
periods.
Regulatory Status
GRAS listed. Included in the FDA Inactive Ingredients Database
(IM, IV: powder for injection solution; IV and sublingual preparations;
oral: capsules and tablets; powder for inhalation; vaginal).
Included in nonparenteral and parenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
