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Claims for Patent: 7,612,073

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Claims for Patent: 7,612,073

Title:Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
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.
Inventor(s): Oppenheimer; Daniel I. (Castro Valley, CA), Dorenbaum; Alejandro (Mill Valley, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:12/329,838
Patent Claims: 1. 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.

2. The method of claim 1 further comprising informing said human that absorption of said BH4 or pharmaceutically acceptable salt thereof is increased when it is ingested with food.

3. The method of claim 1, further comprising informing the human that both the mean maximum plasma concentration (C.sub.max) and area under the plasma concentration-time curve (AUC) of BH4 are increased when the BH4 or pharmaceutically acceptable salt thereof is administered with a high-fat, high-calorie meal, compared to when the BH4 or pharmaceutically acceptable salt thereof is administered under fasted conditions.

4. The method of claim 3, wherein the increases in C.sub.max and AUC are increases of at least 30%.

5. The method of claim 1, wherein said BH4 is a crystalline polymorph, as a hydrochloride salt, that exhibits an X-ray powder diffraction pattern with the following characteristic peaks expressed in d-values (.ANG.): 8.7 (vs), 5.63 (m), 4.76 (m), 4.40 (m), 4.00 (s), 3.23 (s), 3.11 (vs), preferably 8.7 (vs), 6.9 (w), 5.90 (vw), 5.63 (m), 5.07 (m), 4.76 (m), 4.40 (m), 4.15 (w), 4.00 (s), 3.95 (m), 3.52 (m), 3.44 (w), 3.32 (m), 3.23 (s), 3.17 (w), 3.11 (vs), 3.06 (w), 2.99 (w), 2.96 (w), 2.94 (m), 2.87 (w), 2.84 (s), 2.82 (m), 2.69 (w), 2.59 (w), and 2.44 (w).

6. The method of claim 1, wherein the human has been diagnosed with HPA due to BH4-responsive phenylketonuria (PKU).

7. The method of claim 1, wherein the human has been diagnosed with HPA due to BH4 deficiency.

8. The method of claim 1, wherein the frequency of administering the BH4 or pharmaceutically acceptable salt thereof consists of once daily administration.

9. 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.

10. The method of claim 9, wherein the increase in absorption of said BH4 is characterized by increases in mean maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) of at least about 30%.

11. 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.
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