Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-11-24
2002-12-03
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S474000, C424S464000
Reexamination Certificate
active
06488956
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to multi-vitamin and mineral supplements, and particularly to multi-vitamin and mineral supplements for administration to women. The go supplements are specifically tailored to meet nutritional requirements and maintain a woman s health during specific stages of life. The present invention also relates to methods of optimizing the health of women by providing multi-vitamin and mineral supplements which are specifically tailored to achieve optimal regulation of growth, maintenance and repair of body tissue during specific stages of life with minimal side effects. Methods of formulating multi-vitamin and mineral supplements for life stages are also encompassed by the present invention.
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); Document Geigy Scientific Tables, 457-497 (Diem and Cemtuer eds., 7th ed., 1975).
It has further become recognized that various life-stage 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 discloses maximization of iron bioavailability 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, presenting 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.
Multi-vitamin and mineral formulations which are directed specifically to woman have been disclosed in prior patents and in the medical literature.
The Physicians' Desk Reference (PDR) for Nonprescription Drugs, 9th Edition, 718-19 (1988) discloses a complete calcium/vitamin/mineral supplement program formulated for women. The program contains two specific formulas. One formulation is directed to woman between the ages of 14 and 40, and the other formulation is directed to woman over the age of 40. These formulations do not specifically distinguish between the varying physiological states experienced by women throughout the course of their lives. In fact, by providing one formulation for the broad category of woman aged 14-40, this disclosure highlights the need for more specific formulations.
The Handbook of Nonprescription Drugs, 9th Edition, 447-51, discloses amounts of vitamins and minerals which are optimum for pregnant and lactating women. However, no distinction is drawn between what amounts are optimum for pregnant versus lactating women. Further, there is no identification of specific amounts of vitamins and minerals correlating specifically to any other life stages of women. Moreover, the reference teaches that the prime criteria for optimum nutrition are age, weight, height and sex.
WO 95/35098 discloses multi-vitamin and mineral supplements for administration to lactating, non-lactating, and menopausal women which comprise specific regimens of critical nutritional agents. This reference teaches formulations containing high amounts of iron, zinc and vitamin B
12
, and low amounts of vitamin B
12
and vitamin B
6
.
Despite the foregoing efforts to improve vitamin and mineral supplementation for pregnant women, conventional prenatal supplements are not ideally suited for women during other phases of their lives. Moreover, the foregoing efforts to improve vitamin and mineral supplementation for women, in general, have lacked the specificity required for achieving formulations which are truly adapted to meet the physiological needs of woman at various times in their lives. For example, the nutritional needs of lactating women following a pregnancy differ from the nutritional needs of women during pregnancy. The vitamin and mineral requirements for non-lactating and menopausal women also differ from the requirements of pregnant women.
Conventional nutritional formulations are poorly designed for administration to women during various stages of life in which the physiological requirements of the women vary significantly. As such, the previously disclosed multi-vitamin and mineral formulations do not truly meet the specific needs of women. It would therefore be desirable to provide multi-vitamin and mineral supplements which obviate the deficiencies of known vitamin and mineral products while satisfying the long standing need for such supplements.
None of the above described references is admitted to be prior art.
SUMMARY OF THE INVENTION
The present invention overcomes the shortcomings of known nutritional supplements by providing multivitamin and mineral supplements which are specifically tailored for administration to woman during various stages of life, and more specifically to lactating, non-lactating, and menopausal women. The formulations of the invention have been found to maximize the benefits of vitamin and mineral supplementation for women by specifically formulating the products to meet the physiological requirements of women during these life stages.
Moreover, the bioavailability of each vitamin and mineral in a multi-vitamin formulation is affected by the presence of other vitamins and minerals in the formulation, as well as by the amounts of each vitamin and mineral present and the physiological state of the individual using said formulation. Use of the specific formulations of the present invention for the prescribed life stages unexpectedly results in a higher bioavailability of essential nutrients.
The compositions of the invention include certain essential nutritional components in dosage levels which have been found to optimize the maintenance of a woman's health during each of the noted stages of life. Minerals such as calcium, zinc and iron are dosed (i.e. provided in the supplement) in the form of a corresponding pharmaceutically acceptable compound.
According to a first aspect of the invention, a multi-vitamin and mineral supplement for administration to a lactating woman is provided. This supplement is specially designed to aid in fulfilling the dietary needs of women who are producing and secreting milk, that is, lactating women. The multi-vitamin and mineral supplement comprises:
(a) from about 350 mg to about 480 mg of elemental calcium dosed in the form of a pharmaceutically acceptable calcium compound;
(b) from about 400 I.U. to about 600 I.U. of vitamin D;
(c) from about 400 I.U. to about 8,000 I.U. of Beta carotene, or about 3600 I.U. to abo
Cuca Robert C.
Levinson R. Saul
Paradissis George N.
Vanek Patrick Paul
Drugtech Corporation
Nath Gary M.
Nath & Associates PLLC
Travers Russell
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