Amorphous paroxetine composition
AssigneePentech Pharmaceuticals, Inc.
InventorsBruce Ronsen, Ragab El-Rashidy
Life of this patent
Estimating the term…
Abstract
A free-flowing, amorphous paroxetine hydrochloride-ethanol composition suitable as a therapeutic agent for premature ejaculation can be prepared by dissolving paroxetine free base in a hydrochloric acid-ethanol solution followed by drying. In a preferred embodiment, the amount of ethanol present in the amorphous product is in the range of 1 to 4 weight percent based on paroxetine hydrochloride. The amorphous product is stable and substantially non-hygroscopic.
Claims11
A solid, stabilized amorphous paroxetine hydrochloride composition which comprises paroxetine hydrochloride and ethanol;
- the ethanol being present in the composition in an amount not more than about 10 percent by weight, based on said paroxetine hydrochloride.
A process for the production of an amorphous paroxetine hydrochloride-ethanol composition comprising:
- (a) dissolving paroxetine free base in absolute ethanol;
- (b) adding a solution of hydrochloric acid in absolute ethanol to the paroxetine base solution;
- (c) stirring the resulting solution for a period of time sufficient to produce a composition of paroxetine hydrochloride in ethanol;
- and
- (d) drying the paroxetine hydrochloride-ethanol composition.
Dependencies are inferred from the claim text.