Bristol-myers Squibb Compnay

Robert Abramowitz

Nemichand B Jain

Sailesh A Varia

Sunanda A Ranadive

Denise M O'Donoghue

Extended dosage forms of stavudine are provided comprising beadlets formed by extrusion-spheronization and coated with a seal coating. The beadlets are also coated with a modified release coating such that a hard gelatin capsule containing such beadlets will provide blood levels of stavudine over approximately 24 hours. The beadlets are prepared from a dry blend of stavudine, a spheronizing agent, a suitable diluent and a stabilizing amount of magnesium stearate. 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. Also included in the scope of the invention are hard gelatin capsules containing, in addition to the stavudine beadlets, similar beadlets containing other therapeutic agents utilized to treat retroviral infections.

Sustained release beadlets containing stavudine

A three component pharmaceutical formulation of one or more pharmacologically active substances such that greater than 80% of the pharmacologically active substance will be released in the large intestine. The first component comprises the pharmacologically active substance, microcrystalline cellulose, a pH-sensitive polymer, and optionally an osmotic agent. The second component is a delayed release coating, and the third component is an enteric coating.

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West Windsor, NJ, United States of America

Robert Abramowitz