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Claims for Patent: 8,088,398

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Claims for Patent: 8,088,398

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)
Application Number:12/342,744
Patent Claims: 1. A pharmaceutical composition comprising (a) about 0.3-5.0% [w/w] of a pharmaceutically acceptable salt of fesoterodine (b) about 5-25% [w/w] of xylitol or sorbitol, (c) about 20-40% [w/w] of a mixture comprising about 45-80% [w/w] lactose monohydrate and about 20-55% [w/w] microcrystalline cellulose; (d) about 20-80% [w/w] hydroxypropyl methylcellulose; and (e) about 1-10% [w/w] lubricants.

2. The pharmaceutical composition of claim 1, comprising (a) about 4.0 mg fesoterodine hydrogen fumarate (b) about 32-40 mg of xylitol with a mean particle size of about 0.001-0.30 mm (c) about 115-130 mg of a mixture of lactose monohydrate and microcrystalline cellulose (d) about 65-75 mg of HPMC (hydroxypropyl methylcellulose) having a nominal viscosity of about 100,000 mPas when dissolved (about 2% by weight) in water (e) about 65-75 mg of HPMC having a nominal viscosity of about 4,000 mPas when dissolved (about 2% by weight) in water (f) about 8-12 mg of glycerol dibehenate, and (g) about 7-10 mg talc.

3. The pharmaceutical composition of claim 1, comprising (a) about 8.0 mg fesoterodine hydrogen fumarate (b) about 65-80 mg of xylitol with a mean particle size of about 0.001-0.30 mm (c) about 70-85 mg of a mixture of lactose monohydrate and microcrystalline cellulose (d) about 110-130 mg of HPMC having a nominal viscosity of about 100,000 mPas when dissolved (about 2% by weight) in water (e) about 20-30 mg of HPMC having a nominal viscosity of about 4,000 mPas when dissolved (about 2% by weight) in water (f) about 8-12 mg of glycerol dibehenate, and (g) about 7-10 mg talc.

4. The pharmaceutical composition of claim 1, comprising TABLE-US-00031 fesoterodine hydrogen fumarate about 0.5-4.0% xylitol about 5-25% a mixture of lactose monohydrate about 20-40% and microcrystalline cellulose HPMC (high viscosity) about 15-40% HPMC (low viscosity) about 5-25% glycerol dibehenate about 1-5% Talc about 1-5%.

5. The pharmaceutical composition of claim 1, comprising TABLE-US-00032 fesoterodine hydrogen fumarate about 4.0 mg xylitol about 36.0 mg a mixture of lactose monohydrate about 121.5 mg and microcrystalline cellulose HPMC having a nominal viscosity about 70.0 mg of about 100,000 mPa s when dissolved (about 2% by weight) in water HPMC having a nominal viscosity of about 70.0 mg about 4,000 mPa s when dissolved (about 2% by weight) in water glycerol dibehenate about 10.0 mg talc about 8.5 mg

and a coating.

6. The pharmaceutical composition of claim 1, comprising TABLE-US-00033 fesoterodine hydrogen fumarate about 8.0 mg xylitol about 72.0 mg a mixture of lactose monohydrate about 77.5 mg and microcrystalline cellulose HPMC having a nominal viscosity of about about 120.0 mg 100,000 mPa s when dissolved (about 2% by weight) in water HPMC having a nominal viscosity of about about 24.0 mg 4,000 mPa s when dissolved (about 2% by weight) in water glycerol dibehenate about 10.0 mg talc about 8.5 mg

and a coating.

7. A pharmaceutical composition according to any one of claims 2 to 6, comprising a coating of about 15 mg of a mixture of polyvinyl alcohol, PEG, lecithin, talc, titanium dioxide, and indigo carmine aluminum lake.

8. A method of treating a patient suffering from overactive bladder by administering a therapeutically effective amount of a pharmaceutical composition according to any one of claim 1 or 2-6.

9. A method of treating a patient suffering from overactive bladder by administering a therapeutically effective amount of a pharmaceutical composition according to claim 7.

10. The method according to claim 8, wherein the patient has a symptom selected from the group consisting of urinary incontinence, urinary urge incontinence, imperative urinary urge, and increased urinary frequency.

11. The method according to claim 8, wherein the patient suffers from overactive bladder with a symptom selected from the group consisting of urinary urge incontinence, imperative urinary urge, and increased urinary frequency.

12. The method according to claim 9, wherein the patient has a symptom selected from the group consisting of urinary incontinence, urinary urge incontinence, imperative urinary urge, and increased urinary frequency.

13. The method according to claim 9, wherein the patient suffers from overactive bladder with a symptom of urinary urge incontinence, imperative urinary urge, and increased urinary frequency.

14. The pharmaceutical composition of any one of claims 2-4 further comprising a pharmaceutically acceptable coating.

15. The pharmaceutical composition of claim 5 where the xylitol has a mean particle size of about 0.001-0.30 mm.

16. The pharmaceutical composition of claim 6 where the xylitol has a mean particle size of about 0.001-0.20 mm.
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