A PROCESS OF PREPARING CONTROLLED RELEASE FORMULATION OF ERYTHROMYCIN ESTOLATE

摘要

A process. For preparing a. controlled. release formulation, of macrolide such as erythromycin estolate comprising 50-85% by wt said macrolide 3 to 15% by wt polymers and pharmaceutically acceptable carriers such. as. osmotic agent, filler, lubricant and binder,, said process comprises the following steps: a) passing osmotic agent, -filler, binder and erythromycin estolate through # 60 to obtain their mixture; b) granulating the mixture of erythromycin Estolate^ osmotic agent,, filler and binder with ethyl cellulose and/or other water insoluble polymers; c) drying the resultant granules in oven at 55 — 60°C until moisture content comes down to 2,0 - 2.2%. w/w; d) cooling the granules of step (c) at 20— 25 C temperature; e) passing the dried and cooled granules through .#20 to obtain granules of same size; f) lubricating the granules of step (e) with lubricants such as magnesium stearate and purified talc; and g) compressing the lubricated granules into tablet with 10x20 mm oval punch. Dated this 14th day of November, 2003.