Copovidone

Copovidone is a white to yellowish-white amorphous powder. It is typically spray-dried with a relatively fine particle size. It has a slight odor and a faint taste.
Supplier CD Formulation
Product # PE-0467
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product1 Pharmaceutical Excipients
Molecular Formula (C6H9NO)n
Molecular Weight (C6H9NO)n>1000000
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
  • 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 no-observed-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
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.
CAS Number 25086-89-9
Category Binder Excipients
UNII D9C330MD8B
Chemical Name Acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone
Grade Pharmceutical Excipients
Administration route Oral
Dosage Form Oral tablets, oral film-coated tablets, sustained action
Stability and Storage Conditions Copovidone is stable and should be stored in a well-closed container in a cool, dry place.
Source and Preparation 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.
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