Bristol-Myers Squibb Compnay

Nemichand B Jain

Robert Abramowitz

Sailesh A Varia

Ismat Ullah

Robert L Jerzewski

Sunanda A Ranadive

Abu T Serajuddin

Denise M O'Donoghue

Faranak Nikfar

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 pharmaceutical composition is provided which is useful for cholesterol lowering and reducing the risk of a myocardial infarction, which includes a statin, such as pravastatin, lovastatin, simvastatin, atorvastatin, cerivastatin or fluvastatin, in combination with aspirin, in a manner to minimize interaction of aspirin with the statin and minimize side effects of aspirin. A method for lowering cholesterol and reducing risk of a myocardial infarction employing such composition is also provided.

Pharmaceutical composition containing a combination of a statin and aspirin and method

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.

Colonic drug delivery system

An ifetroban composition is provided which has good dissolution properties even on aging, when dispersed in water has a pH of at least 7 and includes a salt of ifetroban, one or more basifying agents, such as magnesium oxide or calcium carbonate, and where in tablet form includes one or more fillers such as mannitol and/or microcrystalline cellulose, one or more disintegrating agents such as crospovidone, one or more lubricants such as magnesium stearate, optionally one or more glidants such as colloidal silicon dioxide, one or more binders such as pregelatinized starch (dry binder) or polyvinyl-pyrrolidone (wet binder) and optionally a film coating containing a film former such as hydroxypropyl cellulose and a plasticizer such as 1,2,3-propanetriol triacetate.

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West Windsor, NJ, United States of America

Nemichand B Jain