Stability characterization of controlled release coprecipitates and solid dispersions.

The present study was conducted to determine the effects of ageing at exaggerated storage conditions on controlled release tablets prepared with indomethacin-Eudragit((R)) coprecipitates (CPs) and solid dispersions (SDs). CPs and SDs compressed as tablets were stored at -20, 4, 37, 45, 55, 37 degrees C/11% RH, 37 degrees C/51% RH and 37 degrees C/91% RH. The samples were analyzed over a period of six months for their dissolution, crystalline reversion and thermal changes.

Comparative evaluation of the severity of gastric ulceration by solid dispersions and coprecipitates of indomethacin.

The ulcerogenic activity of indomethacin was studied in rats following single and chronic doses of indomethacin in the form of pure drug, solid dispersions and coprecipitates. Each formulation was administrated as a suspension in a 2% methylcellulose solution. Gastrointestinal ulceration was assessed, four hours after a single dose and 24 hours following the last dose of a chronic four day dosing regimen, by counting the number of lesions and ulcers present.