Stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof

A process for preparing an oral pharmaceutical dosage form comprising the steps of:

• a) wet granulating paroxetine hydrochloride in the presence of a binder grade of a binder selected from the group consisting of povidone and copovidone, and a filler that is HCl free or non-hygroscopic, to obtain an intra-granular portion of a granulate;
• b) preparing a final blend from the granulate;
• and
• c) converting the final blend to an oral pharmaceutical dosage form.

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 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 2.5% to about 7.5% of povidone, wherein the tablet is prepared by wet granulating paroxetine hydrochloride in the presence of povidone, sodium starch glycolate and dibasic calcium phosphate anhydrous to obtain a granulate, and converting the granulate to a tablet.

A process for preparing a paroxetine hydrochloride tablet comprising the steps of:

• a) wet granulating with water as a processing solvent paroxetine hydrochloride in the presence of sodium starch glycolate, Grade 29 to Grade 32 povidone and dibasic calcium phosphate anhydrous;
• b) milling the granulate;
• c) mixing the granulate with an additional amount of sodium starch glycolate and calcium phosphate dibasic anhydrous;
• d) adding magnesium stearate to obtain a final blend;
• and
• e) compressing the final blend to obtain the tablet.