ABSTRACT

Polyvinylpyrrolidone (PVP) possesses unique physical and chemical properties that make it useful in many pharmaceutical formulations, foods, cosmetics and toiletries as well as industrial applications. PVP preparations are available in different molecular weight ranges, with means varying from a few thousand to over one million. PVP is not metabolized in the body. The excretion of residual monomer or low molecular weight oligomer present in the PVP under investigation could erroneously be interpreted as metabolism of PVP. PVP may be stored at the injection site or at distant sites. The extent of localized storage is dependent upon the molecular weight and amount of PVP injected, and the frequency and site of injections. An extensive body of toxicological data in animals supports the biological inertness of PVP. The acute, subchronic, and chronic toxicity of orally administered PVP is extremely low, with the only effect observed being diarrhea at high doses due to the osmotic action of PVP acting as a bulk purgative.