BigPatents India

A process for preparation of controlled release formulation of an antibacterial drug ciprofloxacin or its pharmaceutically acceptable salts to obtain a release profile wherein the high initial therapeutic concentration of the drug are achieved rapidly and subsequently the drug is released at a controlled rate, the process comprising the steps of: 1. granulating the drug with co-excipient contributing to control release. 2. Blending the granules with exceipient for volume increasing, co-excipient for further enhancing the volume, co-excipient contributing to control release, co-excipient for increasing buoyancy and other inert pharmaceutically accepted excipients. 3. Compressing the blend into tablets and optionally coating the tablets so as to achieve a release profile in order to obtain a C. sub max between 3 to 7 mcg per ml. At a T.sub max of between 2 to 6 hours and to have a larger amount of the drug available with higher AUC value, between 20 to 40 mcg, hours per ml for better clinical results. Drawing: NIL. Total Pages: 24