Vitamin b12 compound supplementation methods and compositions

Abstract

The invention described herein provides new combination products for the cyclical provision of a methylcobalamin compound and a steroid compound in a dosing regimen wherein the total amount of methylcobalamin administered during any one treatment cycle does not exceed 35 mcg. More specifically, the combination products described in this disclosure promote the prevention or treatment of a vitamin B12 deficiency, support the replenishment and or maintenance of healthy blood cell levels, or both, particularly in those experiencing a periodic physiological challenge which may compromise vitamin B12 status or result in an increased requirement for vitamin B12, such as the monthly blood loss experienced by a reproductively cycling human female.

1 . A combination product for administration to a female via a cyclic multiphase dosing treatment regimen, the combination product comprising: (a) a packaging component which comprises a plurality of individual storage elements, each of the storage elements being adapted to maintain a dosage unit of a medication and one or more indicators that relay information concerning one or more dosage units maintained in the product, (b) about 4-about 8 methylcobalamin dosage units that each comprise a therapeutically effective amount of a methylcobalamin compound, each of the methylcobalamin dosage units being contained in a separate storage element, wherein the collective amount of methylcobalamin compound in the combination product is 35 micrograms or less, and (c) about 20-about 24 dosage units of a steroid hormone, each of the steroid hormone dosage units comprising a therapeutically effective amount of one or more steroid hormones or combination thereof. 
     
     
         2 . The combination product of  claim 1 , wherein the steroid hormone comprises an estrogen, a progestogen, or both. 
     
     
         3 . The combination product of  claim 1 , wherein the total amount of methylcobalamin compound in any methylcobalamin dosage unit is less than about 3 mcg. 
     
     
         4 . The combination product of  claim 2 , wherein the total amount of methylcobalamin compound in any methylcobalamin dosage unit is less than about 2.5 mcg. 
     
     
         5 . The combination product of  claim 3 , wherein the total amount of methylcobalamin compound contained in the combination product is less than about 20 mcg. 
     
     
         6 . The combination product of  claim 2 , wherein the combination product comprises (1) a first collection of progestogen-estrogen dosage units of a first amount of a progestogen and an estrogen; (2) a second collection of progestogen-estrogen dosage units comprising a progestogen and an estrogen wherein the amount of the progestogen in the second collection of progestogen-estrogen dosage units is higher than that of the first collection of progestogen-estrogen dosage units; (3) a third collection of progestogen-estrogen dosage units comprising a progestogen and an estrogen wherein the amount of the progestogen in the third collection of progestogen-estrogen dosage units is higher than that of the second collection of progestogen-estrogen dosage units, wherein the amount of estrogen remains constant throughout the first, second, and third collection of progestogen-estrogen dosage units, and (4) a fourth collection of methylcobalamin dosage units, wherein the fourth collection of methylcobalamin dosage units comprises less than about 30 microgram units of methylcobalamin collectively. 
     
     
         7 . The combination product of  claim 6 , wherein the progesterone in the first, second, and third collections of dosage units is levonorgestrel, norgestimate, norethisterone, drospirenone, or dydrogesterone, or a precursor of any thereof. 
     
     
         8 . The combination product of  claim 7 , wherein the estrogen in the first, second, and third collections of dosage units is ethinyl estradiol, 17-beta-estradiol, mestranol, quinestranol, estradiol, estrone, estrin, estriol, estetrol, conjugated equine estrogens or precursors thereof. 
     
     
         9 . The combination product of  claim 6 , wherein all of the dosage units are adapted for oral administration. 
     
     
         10 . The combination product of  claim 6 , wherein the total amount of methylcobalamin compound in the package is less than about 17.5 mcg. 
     
     
         11 . The combination product of  claim 1 , wherein the methylcobalamin compound is added to the dosage form as part of an intermediate methylcobalamin composition comprising about 0.75-1.5 wt. % of the methylcobalamin compound. 
     
     
         12 . The combination product of  claim 1 , wherein the methylcobalamin compound is a salt of a naturally occurring form of methylcobalamin. 
     
     
         13 . The combination product of  claim 1 , wherein each dosage form in the combination product is a tablet having a weight of between about 50 and about 150 mg, and wherein the amount of methylcobalamin compound in each tablet comprising a methylcobalamin compound constitutes about 0.002-about 0.007 wt. % of the tablet. 
     
     
         14 . The combination product of  claim 13 , wherein the tablet further comprises about 0.25-about 0.75 wt. % magnesium stearate. 
     
     
         15 . The combination product of  claim 12 , wherein the methylcobalamin dosage units are free of iron, free of folic acid, free of gluten, is free of sugar, or any two or more thereof. 
     
     
         16 . The combination product of  claim 12 , wherein the methylcobalamin dosage units comprise iron, folic acid, or both. 
     
     
         17 . The combination product of  claim 14 , wherein the methylcobalamin dosage form is free of folic acid and iron. 
     
     
         18 . The combination product of  claim 8 , wherein the dosage units are stored in the package by blister pack.