IP Library Granted Patent US 7,683,040
Granted Patent B2
US 7,683,040 · App. 10/545,530 · Granted Mar 23, 2010

Intranasal formulation of rotigotine

Assignee: SRZ Properties, Inc.
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Quick Facts
Patent No.
US 7,683,040
App. No.
10/545,530
Granted
Mar 23, 2010
Kind
B2
Abstract

This invention pertains to a liquid intranasal pharmaceutical formulation comprising a pharmaceutically acceptable acid addition salt of rotigotine and α-cyclodextrin, preferably in the form of a buffered aqueous solution having a viscosity of 0.5-1.5 mm 2 /s.

Claims (17)

1. A liquid intranasal pharmaceutical formulation comprising a pharmaceutically acceptable acid addition salt of rotigotine and α-cyclodextrin.

2. The formulation of claim 1 , further comprising a buffer system.

3. The formulation of claim 2 , wherein the buffer system is phosphate buffered saline.

4. The formulation of claim 1 , further comprising a viscosity-enhancing substance effective to give a viscosity of 0.5-1.5 mm 2 /s.

5. The formulation of claim 4 , wherein the viscosity-enhancing substance is glycerol.

6. The formulation of claim 1 , having a pH of 5-6.5.

7. The formulation of claim 1 , further comprising a pharmaceutically acceptable acid for adjustment of pH.

8. The formulation of claim 7 , wherein the pharmaceutically acceptable acid is citric acid.

9. The formulation of claim 1 that does not contain any preservative.

10. The formulation of claim 1 that does not contain any antioxidant.

11. The formulation of claim 1 , further comprising an absorption enhancer selected from non-ionic surfactants.

12. The formulation of claim 11 , wherein the absorption enhancer is polysorbate 80 or PEG-40 hydrogenated castor oil.

13. The formulation of claim 1 , wherein the pharmaceutically acceptable acid addition salt of rotigotine is rotigotine hydrochloride.

14. The formulation of claim 13 , comprising 1-6 mg/ml rotigotine hydrochloride in an aqueous buffered solution.

15. The formulation of claim 13 , comprising between 0.03 and 0.1 g/ml α-cyclodextrin in an aqueous buffered solution.

16. The formulation of claim 3 , wherein the formulation comprises 2-5 mg/ml rotigotine hydrochloride, 0.05-0.1 g/ml α-cyclodextrin and 2.2-3% glycerol in phosphate buffered saline.

17. The formulation of claim 16 , further comprising citric acid in an amount effective to adjust pH of the formulation to a value of 5-6.5.

Assignments (4)
MERGER Recorded Jul 12, 2012
From: SRZ PROPERTIES, INC.
To: UCB MANUFACTURING, INC.
Reel/Frame 028535/0324 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2012
From: UCB MANUFACTURING, INC.
To: UCB PHARMA GMBH
Reel/Frame 028535/0397 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2006
From: KRAMER, ROBERT
To: SRZ PROPERTIES, INC.
Reel/Frame 017793/0100 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 1, 2006
From: KRAMER, ROBERT
To: SRZ PROPERTIES, INC.
Reel/Frame 017743/0839 →
Priority Claims (1)
EP 03029680 · Dec 23, 2003 · regional
Continuity (1)
Related Publication 20070191308A1 · Aug 16, 2007