Serotonin reuptake inhibitor formulations
AssigneeAndrx Corporation
InventorsChih-Ming Chen, Boyong Li, Janice Cacace
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Abstract
A process for preparing amorphous paroxetine hydrochloride or sertraline hydrochloride is provided, which comprises preparing a solution in which paroxetine hydrochloride or sertraline hydrochloride and a water-soluble polymer are dissolved in a co-solvent of a volatile organic solvent and water. Said solution is dried to obtain a composition comprising amorphous paroxetine hydrochloride or sertraline hydrochloride and the water-soluble matrix.
Claims46
A process for preparing a solid dispersion comprising an active ingredient and a water-soluble polymer, said process comprising:
- (a) preparing a solution in which an active ingredient and a water-soluble polymer are dissolved in a co-solvent of a volatile organic solvent and water, wherein the active ingredient is a selective aerotonin reuptake inhibitor and a weight ratio of said volatile organic solvent to said water is from about 95:5 to about 60:40;
- and
- (b) drying said solution to produce a solid dispersion comprising the active ingredient dispersed in the water-soluble polymer;
- said drying comprising spray-drying the solution of step (a) onto a pharmaceutically acceptable carrier.
A pharmaceutical composition comprising:
- a solid dispersion of an amorphous form of an acid addition salt of paroxetine;
- and a water soluble polymer;
- said pharmaceutical composition prepared by
- (a) preparing a solution in which said acid addition salt of paroxetine and said water-soluble polymer are dissolved in a co-solvent of a volatile organic solvent and water, wherein a weight ratio of said volatile organic solvent to said water is from about 95:5 to about 60:40;
- and
- (b) drying said solution to produce a solid dispersion comprising the amorphous form of said acid addition salt of paroxetine dispersed in said water-soluble polymer;
- said drying comprising spray-drying the solution of step (a) onto a pharmaceutically acceptable carrier.
A pharmaceutical composition comprising:
- a solid dispersion comprising
- (a) an active ingredient selected from the group consisting of paroxetine free base, an acid addition salt of paroxetine, sertraline free base and an acid addition salt of sertraline;
- and
- (b) a water-soluble polymer;
- wherein said solid dispersion is prepared by drying a solution in which said active ingredient and said water-soluble polymer are dissolved in a co-solvent of a volatile organic solvent and water, wherein a weight ratio of said volatile organic solvent to said water is from about 95:5 to about 60:40 and said drying comprises spray-drying the solution onto a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.