Stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsMichael Fox, Rakefet Cohen, Anne Braunstein, Minutza Leibovici
Life of this patent
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Abstract
Provided are formulations of a stable commercial paroxetine tablet comprising paroxetine hydrochloride anhydrous, povidone, copovidone or HPMC as a binder, and an HCl free/non-hygroscopic filler, prepared by the wet granulation method.
Claims18
A tablet comprising of the following active ingredient and excipients, in weight to weight percentages:
- a) about 10% to about 12.5% of paroxetine hydrochloride anhydrous;
- b) about 70% to about 90% of dibasic calcium phosphate anhydrous;
- c) about 1.5% to about 5% of sodium starch glycolate;
- d) about 0.5% to about 3% of magnesium stearate;
- and
- e) about 2.5% to about 7.5% of one member selected from the group consisting of povidone and co-povidone,
- wherein the tablet is prepared by wet granulating paroxetine hydrochloride anhydrous in the presence of povidone or copovidone, dibasic calcium phosphate anhydrous and sodium starch glycolate to obtain a granulate, and converting the granulate to the tablet, and with the proviso that the paroxetine hydrochloride remains substantially anhydrous during the wet granulation process.
A tablet comprising the following active ingredient and excipients, in weight to weight percentages:
- a) about 10% to about 12.5% of paroxetine hydrochloride anhydrous as an active ingredient;
- b) about 70% to about 90% of dibasic calcium phosphate anhydrous;
- c) about 1.5% to about 5% of sodium starch glycolate;
- d) about 0.5% to about 3% of magnesium stearate;
- and
- e) about 1% to about 4% of HPMC,
- wherein the tablet is prepared by wet granulating paroxetine hydrochloride anhydrous in the presence of HPMC, dibasic calcium phosphate anhydrous and sodium starch glycolate to obtain a granulate, and converting the granulate to the tablet, and with the proviso that the paroxetine hydrochloride remains substantially anhydrous during the wet granulation process.
A tablet comprising the following active ingredient and excipients, in weight to weight percentages:
- a) about 10% to about 12.5% of paroxetine hydrochloride anhydrous;
- b) about 70% to about 90% of dibasic calcium phosphate anhydrous;
- c) about 1.5% to about 5% of sodium starch glycolate;
- d) about 0.5% to about 3% of magnesium stearate;
- and
- e) about 2.5% to about 7.5% of one member selected from the group consisting of povidone and co-povidone.
A tablet comprising the following active ingredient and excipients, in weight to weight percentages:
- a) about 10% to about 12.5% of paroxetine hydrochloride anhydrous as an active ingredient;
- b) about 70% to about 90% of dibasic calcium phosphate anhydrous;
- c) about 1.5% to about 5% of sodium starch glycolate;
- d) about 0.5% to about 3% of magnesium stearate;
- and
- e) about 1% to about 4% of HPMC.
Dependencies are inferred from the claim text.