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.
Type:
Grant
Filed:
May 7, 1998
Date of Patent:
January 2, 2001
Assignee:
Endo Pharmaceuticals, Inc.
Inventors:
William A. Hein, II, Sou-Chan Chang, Huai-Hung D. Kao