Povidone K30

• BPPovidone
• JPPovidone
• Ph. Eur.Povidone
• USP–NFPovidone

Kollidon 30; Plasdone K-29/32; polyvidone; poly(1-vinyl-2-pyrrolidinone); povidonum; PVP; E1201

1-Ethenyl-2-pyrrolidinone homopolymer · [9003-39-8]

(C6H9NO)n · ≈ 44 000–54 000 (weight-average)

Binder

Typical concentrations: 0.5–5% · Dosage forms: Solid, Liquid

Povidone K30 is the grade most widely used as a binder in wet granulation, added as a solution or dry, at about 0.5–5% w/w. It is also used as a carrier and crystallisation inhibitor in solid dispersions, as a solubiliser, as a suspending and dispersing agent (up to about 5%), as a film-former in coatings, and as a viscosity-increasing agent in ophthalmic and topical preparations. It forms the basis of the povidone–iodine complex.

A synthetic polymer of linear 1-vinyl-2-pyrrolidinone units. It is a fine, white to creamy-white, odourless or almost odourless, hygroscopic powder. Povidone grades are designated by their K-value, which reflects the mean molecular weight.

K-value

27.0–32.4 (90–108% of nominal K30)

pH

3.0–5.0 (5% w/v aqueous solution)

Glass transition temperature

about 160–165 °C (dry material)

Hygroscopicity

markedly hygroscopic; takes up large amounts of water at high relative humidity

Solubility

freely soluble in water, ethanol, methanol and chloroform; practically insoluble in ether, hydrocarbons and mineral oil

Povidone darkens and becomes less soluble when heated above about 150 °C, although short exposure to 110–130 °C is tolerated. Aqueous solutions are prone to mould growth and need a preservative. Store in an airtight container in a cool, dry place.

Forms molecular complexes in solution with many substances, including sulfathiazole, sodium salicylate, salicylic acid, phenobarbital and tannin, and can reduce the efficacy of some preservatives such as thimerosal. Peroxide impurities in povidone can oxidise susceptible drugs.

Made by free-radical polymerisation of N-vinylpyrrolidone, usually in water with a hydrogen peroxide initiator; the molecular weight (K-value) is controlled by the reaction conditions. The monomer is obtained from 2-pyrrolidone and acetylene.

Essentially non-toxic orally, as it is not absorbed from the gastrointestinal tract. Higher-molecular-weight grades given parenterally are not readily excreted and can accumulate in tissues, so only low-K grades are used in injections. Hypersensitivity reactions are rare.

Observe normal precautions for the quantity handled. Eye protection, gloves and a dust mask are recommended.

Accepted in Europe as a food additive (E1201) and evaluated by EFSA. Included in the FDA Inactive Ingredient Database (including oral, ophthalmic, topical and parenteral preparations) and in parenteral and non-parenteral medicines licensed in Europe.

Copovidone; crospovidone; povidone–iodine; other povidone grades (K12, K17, K25, K90).

Because povidone is hygroscopic, granules and tablets containing it can soften or become sticky in humid conditions. Low-peroxide grades should be chosen for oxidation-sensitive drugs, and peroxide levels can increase on storage.