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. Samples stored at extremely low temperatures, higher temperatures and humidity conditions exhibited a significant decrease in dissolution rates. However, no significant change in the release rates was observed for samples stored at 4 degrees C. The degree of crystallinity increased over a period of time as confirmed by X-ray diffractometry. DSC data demonstrated that indomethacin exists in two polymorphic forms, Form I (mp 160-161 degrees C) and Form II (mp 153-154 degrees C). CPs showed an endotherm of Form I, whereas SDs showed a mixture of Form I and II.
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