Copovidone

• BPCopovidone
• Ph. Eur.Copovidone
• USP–NFCopovidone

copolyvidone; copolyvidonum; Kollidon VA 64; Kollidon VA 64 Fine; Plasdone S-630; PVP/VA copolymer; vinylpyrrolidone–vinyl acetate copolymer

Copolymer of 1-vinyl-2-pyrrolidone and vinyl acetate in a 6:4 mass ratio · [25086-89-9]

(C6H9NO)n·(C4H6O2)m · ≈ 45 000–70 000 (weight average)

Binder, Coating agent, film former

Typical concentrations: 2–5% binder · Dosage forms: Solid

Used as a tablet binder in wet granulation, dry granulation and direct compression, typically at 2–5% w/w, and as a film-former in tablet coatings and topical sprays. It is one of the main carrier polymers for amorphous solid dispersions made by hot-melt extrusion or spray drying, where it can form most of the formulation. It is also used in cosmetics such as hair sprays.

A white to yellowish-white, amorphous powder or flakes with a slight characteristic odour. It is a random copolymer containing about 60% vinylpyrrolidone and 40% vinyl acetate units, which makes it less hygroscopic and more plastic than povidone.

K-value

nominal 28 (range about 25–31)

Vinyl acetate content

about 35–42% w/w

Glass transition temperature

about 101–106 °C

Solubility

freely soluble (more than 10%) in water, ethanol, 2-propanol and dichloromethane; practically insoluble in ether, liquid paraffin and cyclohexane

Stable when stored dry. It is hygroscopic, although less so than povidone, and caking can occur at high humidity. Store in an airtight container in a cool, dry place.

Compatible with most excipients and drugs. Residual peroxides in the polymer can oxidise sensitive drugs, so the peroxide level should be considered for oxidation-prone actives.

Prepared by free-radical copolymerisation of N-vinyl-2-pyrrolidone and vinyl acetate (6:4) in an organic solvent such as 2-propanol, followed by solvent removal and drying.

Of low oral toxicity, essentially not absorbed from the gastrointestinal tract, and non-irritant to the skin. Its toxicological profile is similar to that of povidone.

Observe normal precautions for the quantity handled. Avoid generating dust; eye protection and gloves are recommended.

Included in the FDA Inactive Ingredient Database (oral capsules and tablets; topical preparations) and in non-parenteral medicines licensed in Europe.

Povidone; crospovidone; polyvinyl acetate; polyvinyl alcohol.

Compared with povidone, copovidone gives tougher, less brittle and less tacky films and better plastic deformation, which helps dry binding. Its Tg, melt viscosity and good solubilising capacity explain its wide use in hot-melt extrusion; plasticisers or surfactants are often added to lower processing temperatures.