Abstract

The research objective is to formulate modified-release tablets of Prednisone which will be stable and bioequivalent to the marketed product RAYOS^® manufactured by Horizon Pharma USA, Inc. Present research involves design of a simple reservoir type drug delivery system that releases the drug as a single pulse after a definite time lag. RAYOS^® involves Skye Pharma’s patented GEOCLOCK™ technology which is a press coated tablet design where the inner immediate release core tablet is housed in a barrier tablet containing Dibasic Calcium Phosphate Dihydrate, Glyceryl Behenate and Polyvinylpyrrolidone. This outer barrier tablet delays the disintegration and dissolution for about 4 hours after which it breaks to expose the inner core tablet to release the drug as a single pulse. In USA, RAYOS^® and in Europe LODOTRA^® is available in 3 strengths namely 1 mg, 2 mg and 5 mg which are pseudo dose proportional to each other. Like marketed product, a look-alike approach was followed in the design of drug delivery system, where immediate release tablets of prednisone were modified-release coated to about 21% w/w build-up of Ethyl Cellulose and Hypromellose 3 cps in the ratio of 8:2. The prepared tablets were stable; showed comparative disintegration, dissolution and promising bio equivalence profile to that of RAYOS^®.