Sustained Release Beadlets Containing Stavudine, Method for Their Production, Pharmaceutical Composition Containing the Same and Use Thereof for Treatment Retroviral Infections

1. Technical Result Increase in efficiency of treatment of retroviral infections. 2. Essence Beadlets formed by extrusion-spheronization comprise stavudine, a spheronizing agent and magnesium stearate in an amount suitable to stabilize stavudine against degradation; said beadlets are coated with a seal coating and a modified release coating. The beadlets are prepared from a dry blend of stavudine, a spheronizing agent, a suitable diluent and a stabilizing amount of magnesium stearate and further are coated with a seal coating and a modified release coating. The magnesium stearate, in contrast to other similar pharmaceutical adjuncts, has been found to stabilize stavudine against degradation due to hydrolysis in the presence of the limited amount of water necessary for the extrusion-spheronization process. Pharmaceutically dosed forms, like hard gelatin capsule as an active ingredient contain such beadlets in an amount, which will provide blood levels of stavudine over approximately 24 hours. 3. Field of Application Medicine. Tables: 3