Multi-vitamin and mineral supplement for pregnant women

Details Multi-vitamin and mineral supplement for pregnant women Multi-vitamin and mineral supplement for pregnant women

1997-05-07

2001-05-08

Harrison, Robert H. (Department: 1619)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C424S442000, C514S904000, C514S905000

Reexamination Certificate

active

06228388

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to multi-vitamin and mineral supplements, and particularly to a novel multi-vitamin and mineral supplement for administration during pregnancy.
2. Description of Related Art
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans. See, e.g., Diplock, “Antioxidant Nutrients and Disease Prevention: An Overview,”
Am. J. Clin. Nutr.,
53:189-193 (1991); Documenta Geigy Scientific Tables, 457-497 (Diem and Cemtuer eds., 7th ed., 1975).
It has further become recognized that various groups of the human population require different quantities and types of vitamins and minerals to prevent or alleviate diseases, as well as to maintain general good health. For example, it is known that pregnant women commonly require iron therapy to prevent or treat iron-deficiency anemia. Various prior patents have been directed to improving the efficacy of iron supplements for use during pregnancy. U.S. Pat. No. 4,994,283, for example, discloses nutritional mineral supplements which include iron and calcium compounds in combination with citrates or tartrates, ascorbates, and fructose. The tendency of calcium to inhibit the bioavailability of iron is said to be reduced in such compositions, so that the conjoint bioavailability of these two minerals is enhanced.
U.S. Pat. No. 4,431,634 maximizes the bioavailability of iron in prenatal iron supplements by maintaining the amount of calcium compounds in the supplement at 300 mg or less and the amount of magnesium compounds at 75 mg or less per dosage unit.
Another approach to the same problem is found in U.S. Pat. No. 4,752,479, wherein a multi-vitamin and mineral dietary supplement is provided which includes (a) one or more divalent dietary mineral components such as calcium or magnesium; and (b) a bioavailable iron component, present in a controlled release form and adapted to be released in a controlled manner in the gastrointestinal tract.
U.S. Pat. No. 4,710,387 discloses a nutritional supplement preparation for pregnant and breast-feeding women which contains 10-20% by weight of protein, 16-28% by weight of fat, 43-65% by weight carbohydrates, and at most 3.5% by weight of moisture, minerals, trace elements and vitamins.
Despite the foregoing efforts to improve vitamin and mineral supplementation for pregnant women, conventional prenatal supplements exhibit several deficiencies. One notable problem is that currently available prenatal vitamins are unitary formulations which do not differentiate the presence and levels of particular nutritional components depending upon the stage of fetal development. Such unitary formulations are wasteful of nutritional materials, and do not take into account the significant variations in the nutritional requirements for both the mother and the developing fetus depending upon the stage of fetal development.
Thus, conventional prenatal supplements typically provide inadequate levels of calcium and other essential nutrients during the third trimester of fetal development when such nutrients are most needed, and may provide excessive levels of other nutrients during the first and second trimesters when such dosage levels are unneeded and perhaps even harmful. For example, the excessive presence of iron in conventional prenatal supplements often produces stomach upset in the mother during the first trimester of fetal growth, when morning sickness is most pronounced.
It would therefore be desirable to provide a prenatal multi-vitamin and mineral supplement which overcomes the aforementioned deficiencies of the prior art.
SUMMARY OF THE INVENTION
The present invention overcomes the shortcomings of known unitary prenatal supplements by providing multi-vitamin and mineral supplements which are specifically tailored for administration during the first, second, and third trimesters of pregnancy. The formulations of the invention have been found to maximize the benefit of vitamin and mineral supplementation both for the developing fetus and the mother, while concurrently minimizing the undesirable side effects characteristic of known prenatal nutritional supplements.
The compositions of the invention include certain essential nutritional components in dosage levels which have been found to optimize fetal development and maintain the mother's health during each of the trimesters of pregnancy.
Thus, the invention provides a multi-vitamin and mineral supplement for administration to a pregnant woman during her first trimester of pregnancy, which comprises:
(a) from about 200 mg to about 300 mg of elemental calcium, dosed in the form of a pharmaceutically acceptable calcium compound;
(b) from about 350 I.U. to about 450 I.U. of vitamin D;
(c) from about 0.5 mg to about 1.5 mg of folic acid;
(d) from about 5 mcg to about 10 mcg of vitamin B
12
;
(e) from about 12 mg to about 20 mg of vitamin B
6
; and
(f) from about 1.0 mg to about 2.0 mg of vitamin B
1
.
A multi-vitamin and mineral supplement for administration to a pregnant woman during her second trimester of pregnancy is provided, which comprises:
(a) from about 275 mg to about 375 mg of elemental calcium, dosed In the form of a pharmaceutically acceptable calcium compound;
(b) from about 400 I.U. to about 500 I.U. of vitamin D;
(c) from about 0.5 mg to about 1.5 mg of folic acid;
(d) from about 7 mcg to about 12 mcg of vitamin B
12
;
(e) from about 14 mg to about 22 mg of vitamin B
6
; and
(f) from about 1.1 mg to about 2.1 mg of vitamin B
1
.
A multi-vitamin and mineral supplement for administration to a pregnant woman during her third trimester of pregnancy is also provided by the invention, wherein the formulation comprises:
(a) from about 450 mg to about 550 mg of elemental calcium, dosed in the form of a pharmaceutically acceptable calcium compound;
(b) from about 450 I.U. to about 550 I.U. of vitamin D;
(c) from about 0.5 mg to about 1.5 mg of folic acid;
(d) from about 9 mcg to about 14 mcg of vitamin B
12
;
(e) from about 16 mg to about 24 mg of vitamin B
6
; and
(f) from about 1.2 mg to about 2.2 mg of vitamin B
1
.
Each of the above prenatal nutritional formulations may be administered in any conventional pharmaceutical delivery system, with or without additional nutritional components as described in further detail below.
If desired, the products of the invention may be conveniently marketed as a prenatal multi-vitamin and mineral system which comprises the three distinct multi-vitamin and mineral supplements described above. The prenatal multi-vitamin and mineral system contemplated by the invention includes means for permitting the pregnant woman to differentiate between the formulations for administration during the first, second, and third trimesters.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The invention is based on the discovery that prenatal multi-vitamin and mineral supplements can be provided which are specifically tailored for administration during each of the trimesters of pregnancy. The products of the invention provide optimum nutritional components and amounts which have been found to benefit fetal growth and the mother's health throughout pregnancy, while concurrently minimizing the undesired side effects of conventional unitary formulations.
According to a first aspect of the invention, a multi-vitamin and mineral supplement for administration to a pregnant woman during her first trimester of pregnancy is provided, which comprises:
(a) from about 200 mg to about 300 mg of elemental calcium, dosed in the form of a pharmaceutically acceptable calcium compound;
(b) from about 350 I.U. to about 450 I.U. of vitamin D;
(c) from about 0.5 mg to about 1.5 mg of folic acid;
(d) from about 5 mcg to about 10 mcg of vitamin B
12
;
(e) from about 12 mg to about 2

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