Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders

• US 20120165363A1
• Filed: 03/08/2012
• Published: 06/28/2012
• Est. Priority Date: 07/17/2002
• Status: Active Grant

• Current Assignee: Avanir Pharmaceuticals, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Avanir Pharmaceuticals, Inc. (Otsuka Holdings Company Limited)
• Inventors: YAKATAN, Gerald, Berg, James, Pope, Laura E., Smith, Richard A.
• Granted Patent: US 8,227,484 B2
• Time in Patent Office: Days
• US Class Current: 514/289
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4709 Non-condensed quinolines and containing further heterocyclic rings
• CPC Class Codes: A61K 31/4748 forming part of bridged ring systems strychnine A61K31/475; morphinan derivatives A61K31/485
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/49 Cinchonan derivatives, e.g. quinine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/02 for peripheral neuropathies

Abstract

Pharmaceutical compositions and methods for treating neurological disorders by administering same are provided. The compositions comprise dextromethorphan in combination with quinidine.

Claims

1. A method for treating pseudobulbar affect or emotional lability, the method comprising administering to a patient in need thereof dextromethorphan in combination with quinidine, wherein the amount of dextromethorphan administered comprises from about 20 mg/day to about 60 mg/day and wherein the amount of quinidine administered comprises from about 10 mg/day to about 30 mg/day with the proviso that the weight-to-weight ratio of dextromethorphan to quinidine is 1:

0.75 or less of quinidine.

2. The method of claim 1, wherein the pseudobulbar affect or emotional lability is caused by a neurodegenerative disease or condition or a brain injury.

3. The method of claim 1, wherein the dextromethorphan and the quinidine are administered as one combined dose per day.

4. The method of claim 1, wherein the dextromethorphan and the quinidine are administered as at least two combined doses per day.

5. The method of claim 1, wherein the amount of quinidine administered comprises from about 20 mg/day to 30 mg/day.

6. The method of claim 1, wherein the amount of dextromethorphan administered comprises from about 40 mg/day to 60 mg/day.

7. The method of claim 1, wherein at least one of the quinidine and the dextromethorphan is in a form of a pharmaceutically acceptable salt.

8. The method of claim 1, wherein at least one of the quinidine and the dextromethorphan is in a form of a pharmaceutically acceptable salt selected from the group consisting of salts of free acids, inorganic salts, salts of sulfate, salts of hydrochloride, and salts of hydrobromide.

9. The method of claim 1, wherein about 20 mg quinidine sulfate is administered per day.

10. The method of claim 1, wherein about 60 mg dextromethorphan hydrobromide is administered per day.

11. The method of claim 1, wherein the dextromethorphan and quinidine are administered in separate doses.

12. The method of claim 1, wherein the weight-to-weight ratio of dextromethorphan to quinidine is 1:

0.65 or less of quinidine.

13. The method of claim 1, wherein about 40 mg dextromethorphan hydrobromide is administered per day.

14. The method of claim 1, wherein about 60 mg of dextromethorphan and about 20 mg of quinidine is administered per day.

15. The method of claim 1, wherein about 40 mg of dextromethorphan and about 20 mg of quinidine is administered per day.

16. The method of claim 1, wherein about 60 mg of dextromethorphan hydrobromide and about 20 mg of quinidine sulfate is administered per day.

17. The method of claim 1, wherein about 40 mg of dextromethorphan hydrobromide and about 20 mg of quinidine sulfate is administered per day.