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Details for Patent: 7,524,812

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Details for Patent: 7,524,812

Title:Pharmaceutical formulation comprising ziconotide
Abstract: The present invention is direct to a method of producing analgesia in a mammalian subject. The method includes administering to the subject an omega conopeptide, preferably ziconotide, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyil, buprenorphine, and sufentanil, or its pharmaceutically acceptable salts thereof, wherein the .omega.-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound. A preferred route of administration is intrathecal administration, particularly continuous intrathecal infusion. The present invention is also directed to a pharmaceutical formulation comprising an omega conopeptide, preferably ziconotide, an antioxidant, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil.
Inventor(s): Ellis; David J. (Los Altos, CA), Miljanich; George P. (Redwood City, CA), Shields; David E. (San Lorenzo, CA)
Assignee: Elan Pharmaceuticals, Inc. (South San Francisco, CA)
Filing Date:Jul 31, 2007
Application Number:11/831,696
Claims:1. A formulation comprising an .omega.-conopeptide, an antioxidant, and clonidine or the pharmaceutically acceptable salts thereof, wherein the formulation is prepared by mixing 100 .mu.g/mL of the .omega.-conopeptide with 0.1 mg/mL of the clonidine in a volume ratio between 1:8 and 8:1, and the .omega.-conopeptide retains its potency and is physically and chemically compatible with the clonidine in the formulation.

2. The formulation according to claim 1, wherein said .omega.-conopeptide is ziconotide.

3. The formulation according to claim 1, wherein said antioxidant is methionine.

4. The formulation according to claim 1, which has pH between 4 to 4.5.

5. The formulation according to claim 1, wherein said .omega.-conopeptide retains at least 80% activity at 37.degree. C. for at least 7 days.

6. A formulation comprising 0.025 mg/mL of an .omega.-conopeptide, an antioxidant, and 0.5-3 mg/mL of clonidine or the pharmaceutically acceptable salts thereof, wherein the .omega.-conopeptide retains its potency and is physically and chemically compatible with the clonidine in the formulation.

7. The formulation according to claim 6, wherein said .omega.-conopeptide is ziconotide.

8. The formulation according to claim 6, wherein said antioxidant is methionine.

9. The formulation according to claim 6, which has pH between 4 to 4.5.

10. The formulation according to claim 6, wherein said .omega.-conopeptide retains at least 80% activity at 37.degree. C. for at least 7 days.

11. A formulation comprising an .omega.-conopeptide, an antioxidant, and baclofen or the pharmaceutically acceptable salts thereof, wherein formulation is prepared by mixing 100 .mu.g/mL of the .omega.-conopeptide with 2 mg/mL of the baclofen in a volume ratio between 1:8 and 8:1, and the .omega.-conopeptide retains its potency and is physically and chemically compatible with the clonidine in the formulation.

12. The formulation according to claim 11, wherein said .omega.-conopeptide is ziconotide.

13. The formulation according to claim 11, wherein said antioxidant is methionine.

14. The formulation according to claim 11, which has pH between 4 to 4.5.

15. The formulation according to claim 11, wherein said .omega.-conopeptide retains at least 80% activity at 37.degree. C. for at least 7 days.

16. A formulation comprising an .omega.-conopeptide, an antioxidant, and baclofen or the pharmaceutically acceptable salts thereof, wherein the formulation provides 0.6-4.8 .mu.g/day of .omega.-conopeptide and 22-800 .mu.g/day of baclofen at a rate of 288 mcl/day when used in a pump.

17. The formulation according to claim 16, wherein said .omega.-conopeptide is ziconotide.

18. The formulation according to claim 16, wherein said antioxidant is methionine.

19. The formulation according to claim 16, which has pH between 4 to 4.5.

20. The formulation according to claim 16, wherein said .omega.-conopeptide retains at least 80% activity at 37.degree. C. for at least 7 days.
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