Chemical Properties
white powder
Uses
Poly(1-vinylpyrrolidone-co-vinyl acetate)
Production Methods
Copovidone is manufactured by free-radical polymerization of
vinylpyrrolidone and vinyl acetate in a ratio of 6 : 4. The synthesis is
conducted in an organic solvent owing to the insolubility of vinyl
acetate in water.
General Description
～1:2.4 mole ratio of VP:VA
Pharmaceutical Applications
Copovidone is used as a tablet binder, a film-former, and as part of
the matrix material used in controlled-release formulations. In
tableting, copovidone can be used as a binder for direct compression and as a binder in wet granulation. Copovidone is often
added to coating solutions as a film-forming agent. It provides good
adhesion, elasticity, and hardness, and can be used as a moisture
barrier.
Safety Profile
Moderately toxic by ingestion.Combustible, especially in powdered form. Incompatiblewith strong oxidising agents, strong reducing agents. Whenheated to decomposition it emits toxic vapors of NOx.
Safety
Copovidone is used widely in pharmaceutical formulations and is
generally regarded as nontoxic. However, it is moderately toxic by
ingestion, producing gastric disturbances. It has no irritating or
sensitizing effects on the skin. A study was conducted to look at the
carcinogenicity and chronic toxicity of copovidone (Kollidon VA
64) in Wistar rats and Beagle dogs. The results of these studies
demonstrated the absence of any significant toxicological findings
of high dietary levels of copodivone in rats and dogs, resulting in noobserved-
adverse-effect levels of 2800 mg/kg body-weight/day in
rats and 2500 mg/kg body-weight/day in dogs, the highest doses
tested.
LD50 (rat, oral): >0.63 g/kg
Solubility in organics
Acetone, chloroform, methanol, THF, water
Solubility in organics
THF (above 68C)
Solubility in organics
THF, water
storage
Copovidone is stable and should be stored in a well-closed container
in a cool, dry place.
Incompatibilities
Copovidone is compatible with most organic and inorganic
pharmaceutical ingredients. When exposed to high water levels,
copovidone may form molecular adducts with some materials; see
Crospovidone and Povidone.
Regulatory Status
Copovidone is included in the FDA Inactive Ingredients Database
(oral tablets, oral film-coated tablets, sustained action).
