Back to results
US 2019/0160070 A1Published application
Dry blend formulation of tetrahydrobiopterin
AssigneeBioMarin Pharmaceuticals
InventorsTianwei Chou, Augustus O. Okhamafe
Life of this patent
Estimating the term…
Abstract
Dry blend powder formulations comprising a pharmaceutical formulation containing tetrahydrobiopterin, and methods of making and using the same, are disclosed herein.
Claims72
A pharmaceutical composition, comprising a dry blend powder of a BH4 or BH4-related compound and an excipient.
A stable capsule dosage form comprising a pharmaceutical formulation comprising an initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride in a crystalline form designated polymorph B, and one or more pharmaceutically acceptable excipients, wherein:
- a. the capsule has a shell that is essentially free of pullulan, and
- b. at least about 98% of the initial amount of the tetrahydrobiopterin dihydrochloride remains after the capsule dosage form is stored in a container at about 40° C. and about 75% relative humidity for a period from about three months to about six months.
Dependencies are inferred from the claim text.