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US 2018/0000823 A1Published application
Stable 5-methyltetrahydrofolate formulations to moderate methylenetetrahydrofolate reductase associated polymorphisms
AssigneeLa Vita Compounding Pharmacy
InventorsDebra K. Hubers, Christine A. Givant
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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).
Claims38
A method of preparing a solution containing 5-methyltetrahydrofolate retaining a potency of between about 90 to 110% for up to 40 days when stored under refrigeration, 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 between about 5% and 25% 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 gentle pH adjuster to adjust the pH to between approximately 3 and 9 while 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.
5 more elements
A composition, comprising:
- (i) about 0.5 to 1.5 mg/mL of calcium L-5-methyltetrahydrofolate (L-5-MTHF Ca);
- (ii) about 11-15 mg/mL citric acid monohydrate,
- (iii) about 1 to 30 mg/mL ascorbic acid;
- (iv) about 0.1 to 10 mg/mL edetate disodium dehydrate;
- (v) about 1 to 30 mg/mL monothioglycerol;
- (vi) metacresol;
- and
- (vii) NaOH or HCl to adjust to pH of about 5 to 8.
5 more elements
Dependencies are inferred from the claim text.