Claims for Patent: 10,406,159

Summary for Patent: 10,406,159

Title:	Stable 5-methyltetrahydrofolate formulations to moderate methylenetetrahydrofolate reductase associated polymorphisms
Abstract:	Provided herein are methods for preparing stable solutions containing 5-methyltetrahydrofolate (MTHF). Also provided herein are stable compositions containing calcium 5-methyltetrahydrofolate (MTHF-Ca).
Inventor(s):	Hubers; Debra K. (Solana Beach, CA), Givant; Christine A. (Solana Beach, CA)
Assignee:	La Vita Compounding Pharmacy (San Diego, CA)
Application Number:	15/546,650
Patent Claims:	1. A method of preparing a solution containing 5-methyltetrahydrofolate retaining a potency of between about 90 to 110% for at least 1 month when stored between about 2.degree. C. and 8.degree. C., comprising the steps of: determining the weight of 5-methyltetrahydrofolate powder and sodium metabisulfite; determining the water content of the 5-methyltetrahydrofolate; adding an excess of 5-methyltetrahydrofolate powder of between about 5% and 25% of the determined weight of 5-methyltetrahydrofolate powder; adding approximately 75% of the total desired volume of sterile water and mixing while keeping the mixture cold; mixing an appropriate amount of preservative into the mixture while keeping the mixture cold; adding a suitable pH adjuster to adjust the pH to between approximately 3 and 9while keeping the mixture cold; and adding enough sterile water to bring the mixture to the desired volume while protecting the mixture from light and keeping the mixture cold, wherein 5-methyltetrahydrofolate or a mixture containing 5-methyltetrahydrofolate is protected from light. 2. The method of claim 1, wherein the excess of 5-methyltetrahydrofolate powder is about 15% of the determined weight of 5-methyltetrahydrofolate powder. 3. The method of claim 2, wherein the preservative comprises benzyl alcohol. 4. The method of claim 2, wherein the pH adjuster comprises sodium phosphate dibasic solution between about 1% to 20%. 5. The method of claim 4, wherein the preservative comprises benzyl alcohol. 6. The method of claim 1, wherein the preservative comprises benzyl alcohol. 7. The method of claim 6, wherein the preservative comprises benzyl alcohol. 8. The method of claim 6, wherein the pH adjuster comprises sodium phosphate dibasic solution between about 1% to 20%. 9. The method of claim 8, wherein the preservative comprises benzyl alcohol. 10. The method of claim 1, wherein the pH is adjusted to between approximately 4 and 8. 11. The method of claim 10, wherein the pH adjuster comprises sodium phosphate dibasic solution between about 1% to 20%. 12. The method of claim 11, wherein the preservative comprises benzyl alcohol. 13. The method of claim 1, wherein the pH is adjusted to between approximately 5 and 5.7. 14. The method of claim 13, wherein the preservative comprises benzyl alcohol. 15. The method of claim 13, wherein the pH adjuster comprises sodium phosphate dibasic solution between about 1% to 20%. 16. The method of claim 15, wherein the preservative comprises benzyl alcohol. 17. The method of claim 1, wherein the pH adjuster comprises sodium phosphate dibasic solution between about 1% to 20%. 18. The method of claim 17, wherein the preservative comprises benzyl alcohol. 19. The method of claim 1, further comprising adding one or more compounds selected from the group consisting of Methylcobalamin, Hydroxocobalamin, Adenosylcobalamin, Thiamine, Riboflavin-5-phosphate, Niacinamide, Pyridoxine, Dexpanthenol, Biopterin, Inositol, Choline, Methionine and Glutathione. 20. The method of claim 1, further comprising adding Methylcobalamin. 21. The method of claim 1, wherein the solution retains potentcy for at least 6 months.

Details for Patent 10,406,159

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2035-01-27