Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
AssigneeBiomarin Pharmaceutical Inc.
InventorsDaniel I. Oppenheimer, Alejandro Dorenbaum
Life of this patent
Estimating the term…
Abstract
The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.
Claims11
A method of treating hyperphenylalaninemia (HPA) comprising orally administering to a patient diagnosed with HPA a therapeutically effective amount of tetrahydrobiopterin (BH4) or a pharmaceutically acceptable salt thereof, at a daily dose of 5 to 20 mg/kg and for a duration of at least 3 weeks or longer, wherein said administering comprises (i) dissolving a tablet or capsule of said BH4 or pharmaceutically acceptable salt thereof in liquid, and separately (ii) taking the dissolved BH4 or pharmaceutically acceptable salt thereof orally with food, at the same time as the food or within approximately 30 minutes after the food.
A method of increasing absorption of tetrahydrobiopterin (BH4), comprising orally administering to a human in need thereof a therapeutically effective amount of BH4 or a pharmaceutically acceptable salt thereof dissolved in a liquid, at the same time as or within approximately 30 minutes after a high fat, high calorie meal, to increase absorption of BH4.
A method of treating hyperphenylalaninemia (HPA) comprising orally administering to a patient diagnosed with HPA a daily dose of 5 to 20 mg/kg of tetrahydrobiopterin (BH4) or a pharmaceutically acceptable salt thereof, wherein said administering comprises (i) dissolving a tablet or capsule of said BH4 or pharmaceutically acceptable salt thereof in liquid, and separately (ii) taking the dissolved BH4 or pharmaceutically acceptable salt thereof orally, at the same time as or within approximately 30 minutes after a high fat, high calorie meal.
Dependencies are inferred from the claim text.