Sidmak Laboratories, Inc.

Watson Laboratories Inc.

Pliva, Inc.

Vinayak T Bhalani

Satishchandra P Patel

Satischandra P Patel

Anjan Kumar Paul

Stable solutions of lipophilic drugs, such as cyclosporin, forming a polar lipid self-emulsifying drug delivery system. The solutions can include lipophilic drugs, such as cyclosporin, dissolved in a polar lipid, such as having a C-Cfatty acid monoglyceride content of at least about 50%, surfactants and triglycerides. The composition forms a fine emulsion on exposure to water. The encapsulated dosage form of this composition needs neither a hydrophilic component nor air-tight blister packaging, and is particularly suitable for oral administration.

Pharmaceutical compositions for lipophilic drugs

The invention comprises a stable solution of cyclosporine forming a polar lipid self-emulsifying drug delivery system ('PLSEDDS'). The composition typically consists of cyclosporine dissolved in a polar lipid, such as a medium chain monoglyceride of C.sub.6 -C.sub.12 fatty acids having a monoglyceride content of at least 50% and a surfactant. The composition provided here instantly forms a fine emulsion on exposure to water. The encapsulated dosage form of this composition needs neither a hydrophilic component nor air-tight blister packaging, and is particularly suitable for oral administration.

Pharmaceutical composition for cyclosporines

A sustained release tablet adapted to provide an initial immediate release of an active agent, a period of no release of the active agent, followed by a substantially constant, rate of release of the active agent. The tablet includes (a) a compressed tablet core containing an active agent, an insoluble binder and an insoluble; (b) a barrier coating formed over the tablet core, the barrier coating including a mixture of soluble and insoluble polymers and a plasticizer; (c) an active coating deposited over the barrier coating, the active coating including an active agent, a soluble polymer and a plasticizer; and (d) a film coating formed over the active coating, the film coating containing a soluble polymer and plasticizer.

Sustained release composition for oral administration of active

A stable, solid choline magnesium salicylte inclusion complex composition which comprises choline salicylate, magnesium salicylate and magnesium aluminum silicate, and granulation method for preparing the solid inclusion complex composition utilizing liquid salicylate is provided. The invention is also directed to methods of administering the compoitions of the invention to treat osteoarthritis, rheumatoid arthritis, and acute painful shoulder.

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Livingston, NJ, United States of America

Vinayak T Bhalani