PAROXETINE COMPOSITIONS
申请(专利)号:
EA19990000655
申请日期:
1998-01-12
公开/公告号:
EA002034B1
公开/公告日期:
2001-12-24
申请(专利权)人:
SMITHCLINE BEECHAM PLC
被引量:
摘要:
1. A process for preparing a free-flowing form of paroxetine hydrochloride which comprises spray drying a solution of paroxetine hydrochloride. 2. A process according to claim 1, in which the feedstock for spray drying is prepared by dissolution of paroxetine free base in aqueous hydrochloric acid. 3. A process according to claim 1, in which the feedstock is prepared by dissolving amorphous paroxetine hydrochloride or a crystalline paroxetine hydrochloride anhydrate, hydrate or solvate in a suitable solvent. 4. A process according to claim 1,2 or 3, in which the solvent is pure water or a mixture of water with one or more compatible organic solvents. 5. A process according to claim 1 or 3 in which the solution of paroxetine hydrochloride is in a suitable organic solvent in the absence of water. 6. A process according to claim 4 or 5 in which the organic solvent is selected from pyridine, acetic acid, acetonitrile, acetone, ethanol, propan-1-ol, butan-1-ol, or tetrahydrofuran. 7. A process according to any one of the preceding claims, wherein the concentration of paroxetine hydrochloride is in the range 5% to 20% by weight. 8. Spray-dried paroxetine hydrochloride. 9. A pharmaceutical composition for treatment or prophylaxis of the disorders comprising spray-dried paroxetine hydrochloride and a pharmaceutically acceptable carrier or an aqueous solution of reconstituted spray-dried paroxetine hydrochloride. 10. The use of spray-dried paroxetine hydrochloride to manufacture a medicament in solid or reconstituted liquid form for the treatment or prophylaxis of the disorders. 11. A method of treating the disorders which comprises administering an effective or prophylactic amount of spray-dried paroxetine hydrochloride as a solid oral composition or as a reconstituted aqueous oral or parenteral composition to a person suffering from one or more of the disorders.
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