Copovidone PVP VA64 in China 25086-89-9 manufacturer CAS NO.25086-89-9

form  powder

Chemical Properties white powder
Chemical Properties 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.
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.
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 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

ENVIRONMENTAL RESPONSIBILITY

 

•  Fully compliant with government requirements and regulations

•  Real time monitoring of waste streams

•  100% recycling of processing water 

•  Complete conversion from coal to natural gas

•  Focus on developing green production processes

 

　　CUSTOMER and TECHNICAL SERVICE

 

•  Technical Research Center to assist our customer with formulation development

•  New R&D center commissioned in 2018 having integrated R&D and pilot manufacturing

•  Customer partnering to develop new opportunities

•  Strong customer and quality management services to assist our customers

 

 

 

KoVidone® VA64  

Product name     KoVidone® VA64 Copovidone

USP/EP name     Copovidone, Copovidonum

INCI/CTFA        VP/VA copolymer 60/40

CAS NO.         25086-89-9

K value          25.2-30.8 (Copovidone 28), 27.0-33.0 (Copovidone 30)

Properties       Hygroscopic capacity lower than KoVidone® K30; Soluble in water, alcohol and many other organic solvents; Glass transition temperature(Tg) lower than KoVidone® K30; Forms transparent, water removable films.

The content of vinyl acetate    35.3-41.0%

Applications

KoVidone® VA64 possesses excellent powder and film properties for broad application in the pharmaceutical field:

·       Water soluble tablet binder; suitable for wet or dry granulation and direct compression processes, improves particle compressibility.

·       Film-former; permeable film coating for tablet and sugar coatings to protect against splitting, decrease moisture sensitivity and provide good film adhesiveness, elasticity, and hardness.

·       Porogenic agent; for use in taste-masking and component of the matrix material used in controlled-release formulation.

·       Solubilizing agents; for solid dispersion processes to enhancing bioavailability and improve drug solubility. For use in both Hot Melt Extrusion and Spray Solvent Drying

The addition of KoVidone® VA64 to HPMC film coating solutions can effectively reduce the viscosity of the HPMC solution while enhancing resultant film characteristics by improving film formation, flexibility and gloss.

Nimodipine- KoVidone® VA64 solid dispersion HME process

Due to its lower glass transition temperature Tg, KoVidone® VA64 is especially suited for developing solid dispersion drug systems via hot melt extrusion processing.

Hot melt extrusion (HME) technology is a new technique to prepare pharmaceutical dosage forms. HME shows unique advantages and is used to: improve the dissolution rate of extremely poorly soluble drugs..

HME uses no solvent in the production process, the drug is hot melt extruded with a suitable polymer carrier (Kovidone® VA64). The extrusion process converts crystalline drugs to their amorphous form (Solid Dispersion) that helps to improve both drug solubility and bioavailability and increase the stability of the finished dosage form.

Solid Dispersions can also be produced via Spray Solvent Drying whereby the Kovidone and poory soluble active are dissolved in a suitable solvent and spray dried. The resulting Solid Dispersion is similar to that achieved with HME.