Patent Number: 6,168,805

Title: Aqueous process for manufacturing paroxetine solid dispersions

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.

Inventors: Hein, II; William A. (Hasbrouck Heights, NJ), Chang; Sou-Chan (Westbury, NY), Kao; Huai-Hung D. (Syosset, NY)

Assignee: Endo Pharmaceuticals, Inc.

International Classification: A61K 9/14 (20060101); A61K 9/20 (20060101); A61K 31/4525 (20060101); A61K 31/4523 (20060101); A61K 009/14 (); A61K 009/20 ()

Expiration Date: 01/02/2018