Aqueous process for manufacturing paroxetine solid dispersions

A - Human Necessities – 61 – K

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Details

A61K 31/445 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 31/4525 (2006.01)

Patent

CA 2331288

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 the crystalline form, and yet has good handling properties, making it suitable for pharmaceutical use in the traditional tablet dosage form.

L'invention concerne un procédé permettant de préparer de la paroxétine amorphe solide consistant: (A) à mélanger une base exempte de paroxétine ou un sel de paroxétine pharmaceutiquement acceptable avec de l'eau et un polymère pharmaceutiquement acceptable; et (B) à laisser sécher de manière à former une composition renfermant de la paroxétine amorphe et un polymère, éliminant ainsi la nécessité d'utiliser des solvants organiques communs pour ce genre de procédé au solvant. La composition de paroxétine solide amorphe obtenue est exempte de toute forme cristalline, mais elle présente quand même de bonnes propriétés de manipulation, ce qui en fait une composition appropriée pour un usage pharmaceutique sous la forme posologique classique de comprimés.

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