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Claims for Patent: 8,003,126

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Claims for Patent: 8,003,126

Title:Stable tablet formulation
Abstract: The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations.
Inventor(s): Jungles; Steven (Novato, CA), Henderson; Mark (Larkspur, CA), Sluzky; Victoria (Corte Madera, CA), Baffi; Robert (Moraga, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:10/563,418
Patent Claims: 1. A formulation, comprising about 100 mg of crystal form B of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride and about 5 mg of ascorbic acid in the form of a tablet.

2. The formulation of claim 1, further comprising crospovidone, dibasic calcium phosphate, D-mannitol, riboflavin and sodium stearyl fumarate.

3. The formulation of claim 1, further comprising crospovidone.

4. The formulation of claim 1, further comprising dibasic calcium phosphate.

5. The formulation of claim 1, further comprising D-mannitol.

6. The formulation of claim 1, further comprising riboflavin.

7. The formulation of claim 1, further comprising sodium stearyl fumarate.

8. A formulation, comprising crystal form B of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride and ascorbic acid in the form of a tablet, wherein the weight ratio of ascorbic acid to (6R)-L-erythro-tetrahydrobiopterin is about 1:5.5, about 1:6, about 1:6.5, about 1:7, about 1:7.5, about 1:8, about 1:8.5, about 1:9, about 1:9.5, about 1:10, about 1:10.5, about 1:11, about 1:11.5, about 1:12, about 1:12.5, about 1:13, about 1:13.5, about 1:14, about 1:14.5, about 1:15, about 1:15.5, about 1:16, about 1:16.5, about 1:17, about 1:17.5, about 1:18, about 1:18.5, about 1:19, about 1:19.5, about 1:20, about 1:20.5, about 1:21, about 1:21.5, about 1:22, about 1:22.5, about 1:23, about 1:23.5, about 1:24, about 1:24.5, about 1:25, about 1:25.5, about 1:26, about 1:26.5, about 1:27, about 1:27.5, about 1:28, about 1:28.5, about 1:29, or about 1:29.5.

9. The formulation of claim 8, further comprising crospovidone, dibasic calcium phosphate, D-mannitol, riboflavin and sodium stearyl fumarate.

10. The formulation of claim 8, further comprising crospovidone.

11. The formulation of claim 8, further comprising dibasic calcium phosphate.

12. The formulation of claim 8, further comprising D-mannitol.

13. The formulation of claim 8, further comprising riboflavin.

14. The formulation of claim 8, further comprising sodium stearyl fumarate.

15. The formulation of claim 8, wherein the weight ratio of ascorbic acid to (6R)-L-erythro-tetrahydrobiopterin is about 1:16.5, about 1:17, about 1:17.5, about 1:18, about 1:18.5, about 1:19, about 1:19.5, about 1:20, about 1:20.5, about 1:21, about 1:21.5, about 1:22, about 1:22.5, about 1:23, about 1:23.5, about 1:24, about 1:24.5, or about 1:25.

16. The formulation of claim 8, wherein the weight ratio of ascorbic acid to (6R)-L-erythro-tetrahydrobiopterin is about 1:19, about 1:19.5, or about 1:20.

17. A formulation, comprising crystal form B of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride and ascorbic acid in the form of a tablet, wherein the weight ratio of ascorbic acid to (6R)-L-erythro-tetrahydrobiopterin is about 1:2, about 1:3, about 1:4, or about 1:5.

18. The formulation of claim 17, further comprising crospovidone.

19. The formulation of claim 17, further comprising dibasic calcium phosphate.

20. The formulation of claim 17, further comprising D-mannitol.

21. The formulation of claim 17, further comprising riboflavin.

22. The formulation of claim 17, further comprising sodium stearyl fumarate.
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