Stable pharmaceutical compositions comprising fesoterodine
AssigneeCadila Healthcare Limited
InventorsSunilendu Bhushan Roy, Sushrut Krishnaji Kulkarni, Pranav Jogani Dhirajbhai, Ajay Handa Kumar
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Abstract
The present invention relates to stable pharmaceutical compositions comprising fesoterodine or salts thereof. In particular, the invention relates to pharmaceutical compositions of fesoterodine which does not contain sugar alcohols. The invention also relates to processes for making such compositions and use thereof in treating patients with urinary incontinence.
Claims25
A stable pharmaceutical composition comprising fesoterodine or salts thereof, one or more rate-controlling polymers and one or more pharmaceutically acceptable excipients, characterized in that the composition is free of sugar alcohol.
A stable pharmaceutical composition comprising:
- (a) about 0.1-10.0% w/w of fesoterodine fumarate;
- (b) about 1.0-5.0% w/w of polyvinyl pyrrolidone;
- (c) about 5.0-45.0% w/w of microcrystalline cellulose;
- (d) about 10.0-60.0%) w/w of hydroxypropyl methycellulose;
- (e) about 0.1-0.3% w/w of one or more of talc, magnesium stearate and colloidal silicone dioxide;
- and
- characterized in that the composition is free of sugar alcohol.
The stable pharmaceutical composition of claim 21, wherein the composition further comprises about 3.0% to about 20.0% w/w of starch.
A process for the preparation of a stable pharmaceutical composition comprising fesoterodine or salts thereof, the process comprising dry or wet granulating fesoterodine or a salt thereof with one or more rate controlling polymers and one or more pharmaceutical excipients.
A process for the preparation of a stable pharmaceutical composition comprising fesoterodine or salts thereof, the process comprising mixing and compressing fesoterodine or salts thereof with one or more rate-controlling polymers optionally, with one or more pharmaceutically acceptable excipients, wherein the composition is free of sugar alcohol.
A method of treating a patient suffering from overactive bladder by administering a therapeutically effective amount of a stable pharmaceutical composition comprising fesoterodine or salts thereof, one or more rate-controlling polymers and one or more pharmaceutically acceptable excipients, characterized in that the composition is free of sugar alcohol.
Dependencies are inferred from the claim text.