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Claims for Patent: 7,947,681

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Claims for Patent: 7,947,681

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), Okhamafe; Augustus (Concord, CA), Foehr; Erik (San Rafael, CA), Castillo; Sianna (San Francisco, CA), Kostel; Paul J. (Santa Rosa, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:12/577,509
Patent Claims: 1. A method of orally administering tetrahydrobiopterin (BH4), comprising separately administering to a human in need thereof (i) a therapeutically effective amount of BH4 or a pharmaceutically acceptable salt thereof and (ii) food, wherein the BH4 or pharmaceutically acceptable salt thereof is administered at the same time as or within 30 minutes after the food.

2. The method of claim 1, further comprising informing the human that Cmax and AUC are increased by approximately 30% 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 fasting conditions.

3. 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(A): 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).

4. The method of claim 1, wherein the BH4 or pharmaceutically acceptable salt thereof is administered at a daily dose of at least 5 mg/kg.

5. The method of claim 1, wherein the BH4 or pharmaceutically acceptable salt thereof is administered at a daily dose of at least 20 mg/kg.

6. The method of claim 1, wherein the human has been diagnosed with hyperphenylalaninemia, a neuropsychiatric disorder, a cardiovascular disease, anemia, or a combination thereof.

7. 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, compared to when ingested without food.

8. The method of claim 1, wherein said human suffers from one or more disorders selected from the group consisting of phenylketonuria, hyperphenylalaninemia, BH4 deficiency, dopa-responsive dystonia (DRD), sepiapterin reductase (SR) deficiency, or dihydropteridine reductase (DHPR) deficiency, Parkinson's disease, dystonia, pain, fatigue, depression, an affective disorder, schizophrenia, stroke, migraine headaches, Alzheimer's disease, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, other psychotic disorders, tardive dyskinesia, chronic fatigue syndrome, acute or chronic depression, chronic stress syndrome, fibromyalgia, attention deficit hyperactivity disorder, bipolar disease, and autism.

9. The method of claim 1, wherein the food comprises a high fat, high calorie meal.

10. The method of claim 1 or claim 8, further comprising dissolving the BH4 or pharmaceutically acceptable salt thereof in a liquid prior to administering to the human.

11. The method of claim 1 or claim 8, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as an intact tablet.

12. The method of claim 1 or claim 8, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as a solid dosage form.

13. The method of claim 1, wherein the BH4 or pharmaceutically acceptable salt thereof is administered once per day.

14. The method of claim 13, wherein the human suffers from hyperphenylalaninemia.

15. The method of claim 13, wherein the human suffers from one or more disorders selected from the group consisting of BH4 deficiency, dopa-responsive dystonia (DRD), sepiapterin reductase (SR) deficiency, and dihydropteridine reductase (DHPR) deficiency.

16. The method of claim 13, wherein the human suffers from one or more disorders selected from the group consisting of Parkinson's disease, dystonia, pain, fatigue, depression, an affective disorder, schizophrenia, stroke, migraine headaches, Alzheimer's disease, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, delusional disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, other psychotic disorders, tardive dyskinesia, chronic fatigue syndrome, acute or chronic depression, chronic stress syndrome, fibromyalgia, and bipolar disease.

17. The method of claim 13, wherein the human suffers from attention deficit hyperactivity disorder or autism.

18. The method of claim 13, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as a solid dosage form.

19. The method of claim 13, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as an intact tablet.

20. The method of claim 13, further comprising dissolving the BH4 or pharmaceutically acceptable salt thereof in a liquid prior to administering to the human.

21. A method of orally administering tetrahydrobiopterin (BH4) to a human suffering from hyperphenylalaninemia, comprising separately administering to said human (i) a therapeutically effective amount of BH4 or pharmaceutically acceptable salt thereof, once per day, and (ii) food, wherein the BH4 or pharmaceutically acceptable salt thereof is administered at the same time as or within 30 minutes after the food.

22. The method of claim 21, wherein the human suffers from phenylketonuria.

23. The method of claim 21, wherein the therapeutically effective amount of BH4 or pharmaceutically acceptable salt thereof is at least 5 mg/kg.

24. The method of claim 21, wherein the therapeutically effective amount of BH4 or pharmaceutically acceptable salt thereof is 1 mg/kg to 30 mg/kg.

25. The method of claim 21, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as a solid dosage form.

26. The method of claim 21, wherein the BH4 or pharmaceutically acceptable salt thereof is administered as an intact tablet.

27. The method of claim 21, further comprising dissolving the BH4 or pharmaceutically acceptable salt thereof in a liquid prior to administering to the human.

28. The method of claim 21, wherein the food comprises a high fat, high calorie meal.
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