Smithkline Beecham Corporation

Christopher Edmund Valder

John Peter Warr

David Roy Merrifield

Andrew Robert Souter

Petrus Paulus Cornelis Avontuur

A wet granulation process in which a pharmaceutical substance is granulated using a granulating fluid which is a halogenated hydrocarbon which has a normal boiling point below ambient temperature, for example 1,1,1,2-tetraflouroethane, under a pressure sufficient to maintain the halogenated hydrocarbon in a liquid state. A process in which the halogenated hydrocarbon is re-cycled, and suitable equipment for performing the process is also described.

Process

A process, and a suitable apparatus, for production of particles of a material in which stream of a dispersion of the material in a solvent and a stream of a compressible fluid antisolvent substance are mixed under conditions such that the substance is in compressible fluid antisolvent state. The mixture then flows along a conduit ( ) toward an orifice ( ), from which it flows into a downstream region in which the compressible fluid antisolvent substance decompresses and the material is isolated in a particulate state. Preferably the antisolvent substance is a supercritical fluid. The process and apparatus can generate a co-formulation of the material with additives which can be introduced in a suitable aqueous or solvent based carrier vehicle.

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Harlow, United Kingdom

Christopher Edmund Valder