Aqueous process for manufacturing paroxetine solid dispersions

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Title: Aqueous process for manufacturing paroxetine solid dispersions
United States Patent: 6,168,805
Inventors: Hein, II; William A. (Hasbrouck Heights, NJ); Chang; Sou-Chan (Westbury, NY); Kao; Huai-Hung D. (Syosset, NY)
Assignee: Endo Pharmaceuticals, Inc. (Chadds Ford, PA)
Appl. No.: 074355
Filed: May 7, 1998
Abstract
A process for preparing solid, amorphous paroxetine comprising: (A) mixing paroxetine free base or a pharmaceutically acceptable paroxetine salt with water and pharmaceutically acceptable polymer; and (B) drying to form a composition comprising amorphous paroxetine and polymer, eliminating the need for organic solvents common for the solvent process. The resultant amorphous solid paroxetine composition is free from crystalline form, and yet has good handling properties, making it suitable for pharmaceutical use in the traditional tablet dosage form.