Claims for Patent: 9,216,178
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Summary for Patent: 9,216,178
| Title: | Dry blend formulation of tetrahydrobiopterin |
| Abstract: | Dry blend powder formulations comprising a pharmaceutical formulation containing tetrahydrobiopterin, and methods of making and using the same, are disclosed herein. |
| Inventor(s): | Chou; Tianwei (El Cerrito, CA), Okhamafe; Augustus O. (Concord, CA) |
| Assignee: | BioMarin Pharmaceutical Inc. (Novato, CA) |
| Application Number: | 13/666,697 |
| Patent Claims: |
1. A pharmaceutical composition, comprising a dry blend powder that comprises about 32% by weight of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride, about 54% by weight
of mannitol, about 1.9% by weight of sucrolose, about 10.4% by weight of potassium citrate, and about 1.6% by weight of ascorbic acid; wherein at least 90% of the initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride in the pharmaceutical
composition remains after the pharmaceutical composition is stored at 40.degree. C. and 75% relative humidity for a period of three months.
2. The pharmaceutical composition of claim 1, wherein the initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride in the pharmaceutical composition is in a range from about 100 mg to about 500 mg. 3. The pharmaceutical composition of claim 1, wherein the initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride in the pharmaceutical composition is about 100 mg. 4. The pharmaceutical composition of claim 1, wherein the initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride in the pharmaceutical composition is about 500 mg. |
