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Details for Patent: 9,364,541

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Details for Patent: 9,364,541

Title:Pharmaceutical compositions comprising Fesoterodine
Abstract: The present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Inventor(s): Mika; Hans-Jurgen (Bonn, DE), Arth; Christoph (Dusseldorf, DE), Komenda; Michael (Koln, DE), Bicane; Fatima (Rosrath, DE)
Assignee: UCB PHARMA GMBH (Monheim, DE)
Filing Date:Jul 02, 2013
Application Number:13/933,788
Claims:1. A pharmaceutical composition comprising fesoterodine, or a pharmaceutically acceptable salt thereof, and sorbitol, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 11-50% [w/w].

2. The pharmaceutical composition of claim 1, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 50% [w/w].

3. A pharmaceutical composition comprising fesoterodine, or a pharmaceutically acceptable salt thereof, and sorbitol, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 1-30% [w/w].

4. The pharmaceutical composition of claim 3, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 1-20% [w/w].

5. The pharmaceutical composition of claim 3, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 3-15% [w/w].

6. The pharmaceutical composition of claim 3, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 5-10% [w/w].

7. The pharmaceutical composition of claim 1, where the ratio of fesoterodine or a pharmaceutically acceptable salt thereof to sorbitol is about 11% [w/w].

8. The pharmaceutical composition of claim 3, comprising a fesoterodine salt that is a salt of a di- or tricarboxylic acid, or of a partially hydrogenated di- or tricarboxylic acid.

9. The pharmaceutical composition of claim 8, comprising fesoterodine hydrogen fumarate.

10. The pharmaceutical composition of claim 9, which is in unit dosage form and comprises fesoterodine hydrogen fumarate in an amount of between 0.5 and 12 mg per dosage unit.

11. The pharmaceutical composition of claim 10, which comprises about 4 mg fesoterodine hydrogen fumarate per dosage unit.

12. The pharmaceutical composition of claim 10, which comprises about 8 mg fesoterodine hydrogen fumarate per dosage unit.

13. The pharmaceutical composition of claim 10, which is obtainable by wet granulation performed in the presence of water.

14. The pharmaceutical composition of claim 10, where the pharmaceutical composition further comprises a sustained release agent.

15. The pharmaceutical composition of claim 14, where the sustained release agent is a cellulose ether or ester or a mixture thereof.

16. The pharmaceutical composition of claim 14, where the sustained release agent is hydroxypropylmethylcellulose.

17. The pharmaceutical composition of claim 15, where the sustained release agent is contained in an amount of about 20-80% [w/w], based on the total composition.

18. A method of treating a patient suffering from overactive bladder by administering a therapeutically effective amount of the pharmaceutical composition of claim 3 to the patient.

19. The method of claim 18 where the patient has a symptom selected from the group consisting of urinary incontinence, urinary urge incontinence, imperative urinary urge, and increased urinary frequency.
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