Crospovidone

• BPCrospovidone
• Ph. Eur.Crospovidone
• USP–NFCrospovidone

cross-linked povidone; crospovidonum; insoluble polyvinylpyrrolidone; Kollidon CL; Kollidon CL-F; Kollidon CL-SF; Kollidon CL-M; Polyplasdone XL; Polyplasdone XL-10; Polyplasdone Ultra; polyvinylpolypyrrolidone; PVPP; E1202

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

(C6H9NO)n · > 1 000 000

Disintegrant

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

A water-insoluble 'superdisintegrant' used in tablets made by direct compression or by wet or dry granulation, typically at 2–5% w/w, and in orally disintegrating tablets. Micronised grades are used as suspension stabilisers and to improve dissolution of poorly soluble drugs. In the food industry it is used to clarify and stabilise beverages.

A white to creamy-white, finely divided, free-flowing, practically tasteless, odourless or nearly odourless, hygroscopic powder. Pharmacopoeias describe a coarser Type A and a finer Type B.

Particle size

coarse grades with mean size of about 100 µm or more; fine grades about 20–40 µm; micronised grades smaller

pH

5.0–8.0 (1% w/v aqueous suspension)

Peroxides

not more than 400 ppm (Type A) or 1000 ppm (Type B)

Solubility

practically insoluble in water and most common organic solvents; swells rapidly in water without forming a gel

Stable, but hygroscopic. Store in an airtight container in a cool, dry place.

Compatible with most organic and inorganic pharmaceutical ingredients. In the presence of high levels of water it may form molecular adducts with some materials, for example sulfathiazole, sodium salicylate, salicylic acid, phenobarbital and tannin. Peroxide impurities can oxidise sensitive drugs.

Made by 'popcorn' polymerisation of N-vinyl-2-pyrrolidone in the presence of a small amount of a cross-linking agent formed in situ, which gives a highly cross-linked, porous, insoluble polymer.

Not absorbed after oral administration because of its high molecular weight and insolubility, and generally regarded as non-toxic and non-irritant.

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

Accepted as a food additive in Europe (E1202). Included in the FDA Inactive Ingredient Database (oral capsules, granules and tablets) and in non-parenteral medicines licensed in Europe.

Copovidone; povidone; croscarmellose sodium; sodium starch glycolate.

Crospovidone works mainly by capillary wicking and recovery of particles deformed during compression, rather than by gelling, so it does not slow dissolution by forming a viscous layer and its action is largely independent of pH. Coarse grades disintegrate faster, while fine grades give smoother tablet surfaces and better mouthfeel in orally disintegrating tablets.