ABSTRACT
Controlled-release formulations can enhance a drug's efficacy, safety, and duration of activity by regulating the rate and extent of drug release. 'Osmosin' (sodium indomethacin trihydrate) incorporates a newly developed osmotic system for oral administration. It is designed to release precisely a solution of drug at a predetermined rate into the gastro-intestinal lumen. Drug dissolution is programmed by the form itself and is independent of gastro-intestinal variables such as pH and motility. In vitro testing of this oral precision-release dosage form has been paralleled by a high degree of in vivo predictability. Certain drugs are better candidates for oral precision-release systems than others. Indomethacin is particularly well suited for incorporation into such a system. Comparisons with conventional drug forms have shown 'Osmosin' to produce more sustained and constant drug release profiles.
