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Last Updated: September 21, 2021

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Claims for Patent: 9,901,640


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Summary for Patent: 9,901,640
Title:Controlled release formulations of levodopa and uses thereof
Abstract: A modified release levodopa dosage form.
Inventor(s): Hsu; Ann (Los Altos Hills, CA), Kou; Jim (San Jose, CA), Alani; Laman (Fort Worth, TX)
Assignee: Impax Laboratories, Inc. (Hayward, CA)
Application Number:15/382,851
Patent Claims: 1. An oral modified release dosage form comprising carbidopa, levodopa, a carboxylic acid, and a modified release excipient that provides for the modified release of the carbidopa, levodopa and carboxylic acid from the dosage form, wherein the carboxylic acid and levodopa are present in the dosage form in a carboxylic acid to levodopa molar ratio of greater than 1:4 and less than 4:1, and wherein following administration of the dosage form every six hours produces a peak-to-trough levodopa plasma level of about 1 to about 3.

2. The oral modified release dosage form of claim 1, wherein the peak levodopa plasma level occurs about 0.1 hours to about 2 hours after administration of the oral modified release dosage form.

3. The oral modified release dosage form of claim 1, wherein the carboxylic acid is selected from the group consisting of tartaric acid, adipic acid, succinic acid, citric acid, benzoic acid, acetic acid, ascorbic acid, edetic acid, fumaric acid, lactic acid, malic acid, oleic acid, sorbic acid, stearic acid, palmitic acid, boric acid and mixtures thereof.

4. The oral modified release dosage form of claim 3, wherein the carboxylic acid is tartaric acid.

5. The oral modified release dosage form of claim 1, wherein the carboxylic acid and levodopa are present in the dosage form in a carboxylic acid to levodopa molar ratio of greater than 1:4 and less than 3:2.

6. The oral modified release dosage form of claim 1, wherein the carboxylic acid and levodopa are present in the dosage form in a carboxylic acid to levodopa molar ratio of greater than 1:2 and less than 4:3.

7. The oral modified release dosage form of claim 1, wherein the modified release excipient comprises a delayed release polymer.

8. The oral modified release dosage form of claim 7, wherein the delayed release polymer comprises an enteric polymer.

9. The oral modified release dosage form of claim 1, wherein the dosage form is a multiparticulate dosage form.

10. The oral modified release dosage form of claim 9 wherein the multiparticulates are encapsulated.

11. The oral modified release dosage form of claim 9, wherein the multiparticulates are in a sprinkle form that can be sprinkled onto food or liquids for administration.

12. A method for alleviating at least one symptom of Parkinson's disease comprising administering the oral modified release dosage form of claim 1 every six hours.

13. The method of claim 12, wherein a peak-to-trough levodopa plasma level of about 1 to about 2.5 is maintained from about 1 hour to about 6 hours after administration of the oral modified release dosage form.

14. The method of claim 13 wherein a peak-to-trough levodopa plasma level of about 1 to about 2.0 is maintained from about 1 hour to about 6 hours after administration of the oral modified release dosage form.

15. An oral modified release dosage form comprising carbidopa, levodopa, tartaric acid, and a modified release excipient that provides for the modified release of the carbidopa, levodopa and tartaric acid from the dosage form, wherein the molar ratio of tartaric acid to levodopa is greater than 1:4 and less than 4:1.

16. The oral modified release dosage form of claim 15, wherein the tartaric acid and levodopa are present in the dosage form in a tartaric acid to levodopa molar ratio of greater than 1:4 and less than 3:2.

17. The oral modified release dosage form of claim 15, wherein the tartaric acid and levodopa are present in the dosage form in a tartaric acid to levodopa molar ratio of greater than 1:2 and less than 4:3.

18. The oral modified release dosage form of claim 15, wherein the modified release excipient comprises a delayed release polymer.

19. The oral modified release dosage form of claim 18, wherein the delayed release polymer comprises an enteric polymer.

20. The oral modified release dosage form of claim 15, wherein the dosage form is a multiparticulate dosage form.

21. The oral modified release dosage form of claim 20, wherein the multiparticulates are encapsulated.

22. The oral modified release dosage form of claim 20, wherein the multiparticulates are in a sprinkle form that can be sprinkled onto food or liquids for administration.

23. A method for alleviating at least one symptom of Parkinson's disease comprising administering the oral modified release dosage form of claim 15 every six hours.

24. The method of claim 23, wherein a peak-to-trough levodopa plasma level of about 1 to about 2.5 is maintained from about 1 hour to about 6 hours after administration of the oral modified release dosage form.

25. The method of claim 24 wherein a peak-to-trough levodopa plasma level of about 1 to about 2.0 is maintained from about 1 hour to about 6 hours after administration of the oral modified release dosage form.

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