Pharmaceutical composition effective in preventing the adverse effects associated with the prolonged use of dihydrofolate reductase inhibitors
AssigneeCompanion Supplements, LLC
InventorsJulio César Villamil Torres, Camilo Rey Ferro
Life of this patent
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Abstract
The present invention relates to pharmaceutical compositions containing a combination of reduced forms of folate, liver protectors, vitamins, and essential or non-essential amino acids, useful in preventing the adverse effects associated with prolonged use of dihydrofolate reductase inhibitors.
Claims21
A tablet or capsule, consisting essentially of:
- a. a reduced form of folate selected from the group consisting of 5-methyltetrahydrofolate, folinic acid, and pharmaceutically acceptable salts thereof;
- b. milk thistle (Silybum marianum) standardized extract;
- c. at least one B complex vitamin;
- and
- d. at least one amino acid selected from the group consisting of L-methionine, L-serine, and L-glycine;
A tablet or capsule, consisting essentially of:
- a. Folate (as 5-methyltetrahydrofolate), in an amount between 200.0 μg and 5.0 mg;
- b. Milk thistle (Silybum marianum) extract (standardized to 80% Silymarin), in an amount between 40.0 mg and 400.0 mg;
- c. Vitamin B12 as methylcobalamin, in an amount between 6.0 μg and 1,000.0 μg;
- d. Vitamin B6 as pyridoxine hydrochloride, in an amount between 2.0 mg and 100.0 mg;
- e. Vitamin B2 as riboflavin, in an amount between 1.7 mg and 100.0 mg;
- f. L-Methionine, in an amount between 25.0 mg and 400.0 mg;
- g. L-Serine, in an amount between 25.0 mg and 400.0 mg;
- and
- h. L-Glycine, in an amount between 25.0 mg and 400.0 mg.
A tablet or capsule, consisting essentially of:
- a. Folate (as 5-methyltetrahydrofolate), in an amount of 800.0 μg and 2.0 mg;
- b. Milk thistle (Silybum marianum) extract (standardized to 80% Silymarin), in an amount between 75.0 mg and 200.0 mg;
- c. Vitamin B12 as methylcobalamin, in an amount between 25.0 μg and 100.0 μg;
- d. Vitamin B6 as pyridoxine hydrochloride, in an amount between 5.0 mg and 50.0 mg;
- e. Vitamin B2 as riboflavin, in an amount between 2.5 mg and 50.0 mg;
- f. L-Methionine, in an amount between 50.0 mg and 250.0 mg;
- g. L-Serine, in an amount between 50.0 mg and 250.0 mg;
- and
- h. L-Glycine, in an amount between 50.0 mg and 250.0 mg.
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A method for preparing a pharmaceutical composition that prevents folate deficiency, comprising:
- a. sift 5-MTHF, vitamin B12 and colloidal silicon dioxide through a mesh #100;
- b. perform a geometric dilution of folate and vitamin B12 in colloidal silicon dioxide and mix for at least 5 minutes after each dilution;
- c. sift vitamins B6 and B2 through a mesh #40, add them to the premix obtained in step “b” and mix for at least 5 minutes;
- d. sift milk thistle extract through a mesh #30, add them to the preparation of step “c” and mix for at least 5 minutes;
- e. sift the amino acids L-methionine, L-serine and L-glycine through a mesh #20 and premix them for at least 5 minutes;
- f. place the premixes obtained in steps “d” and “e” in a “V” mixer and mix them for at least 10 minutes;
- g. sift microcrystalline cellulose through a mesh #30, add it to the “V” mixer and mix for at least 5 minutes;
- h. add vegetable magnesium stearate, previously sieved through a mesh #60, to the “V” mixer and mix for no more than 3 minutes;
- and
- i. fill hard gelatin capsules “#00” to reach an average weight of 700 mg per capsule, wherein the resulting capsule consists essentially of:
- a. a reduced form of folate;
- b. milk thistle (Silybum marianum) standardized extract
- c. at least one B complex vitamin;
- and
- d. at least one amino acid selected from the group consisting of methionine, serine, and glycine.
A tablet or capsule consisting essentially of milk thistle extract, colloidal silicon dioxide and magnesium stearate.
A tablet or capsule, consisting essentially of:
- a. at least one of 5-methyltetrahydrofolate, folinic acid, and pharmaceutically acceptable salts thereof;
- b. milk thistle (Silybum marianum) standardized extract;
- c. at least one of vitamins B2, B6, and B12;
- and
- d. at least one of L-methionine, L-serine, and L-glycine.
Dependencies are inferred from the claim text.