U.S. patent application number 10/207968 was filed with the patent office on 2002-12-12 for multi-vitamin and mineral supplements for women.
This patent application is currently assigned to K-V Pharmaceutical Company. Invention is credited to Cuca, Robert C., Levinson, R. Saul, Paradissis, George N., Vanek, Patrick Paul.
Application Number | 20020187205 10/207968 |
Document ID | / |
Family ID | 27383733 |
Filed Date | 2002-12-12 |
United States Patent
Application |
20020187205 |
Kind Code |
A1 |
Paradissis, George N. ; et
al. |
December 12, 2002 |
Multi-vitamin and mineral supplements for women
Abstract
Multi-vitamin and mineral supplements for administration to
non-lactating women, which comprise specific regimens of vitamins
and minerals tailored to meet the physiological needs of said
women. Methods for 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 for formulating a multi-vitamin and mineral
supplement that optimize the health of a woman and which comprise
identifying life stages which correlate to specific nutritional
requirements as a result of varying physiological conditions during
a lifetime and selecting specific types and optimal amounts of
vitamins and minerals for said life stages.
Inventors: |
Paradissis, George N.; (St.
Louis, MO) ; Levinson, R. Saul; (Chesterfield,
MO) ; Cuca, Robert C.; (Glen Carbon, IL) ;
Vanek, Patrick Paul; (Middletown, MD) |
Correspondence
Address: |
Gary M. Nath
NATH & ASSOCIATES PLLC
Sixth Floor
1030 Fifteenth Street, N.W.
Washington
DC
20005
US
|
Assignee: |
K-V Pharmaceutical Company
St. Louis
MO
|
Family ID: |
27383733 |
Appl. No.: |
10/207968 |
Filed: |
July 31, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10207968 |
Jul 31, 2002 |
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09448744 |
Nov 24, 1999 |
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09448744 |
Nov 24, 1999 |
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09128466 |
Aug 4, 1998 |
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09128466 |
Aug 4, 1998 |
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08474071 |
Jun 7, 1995 |
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5869084 |
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08474071 |
Jun 7, 1995 |
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08262515 |
Jun 20, 1994 |
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Current U.S.
Class: |
424/647 ;
424/682; 514/168; 514/251; 514/276; 514/458; 514/52; 514/725 |
Current CPC
Class: |
A23V 2250/156 20130101;
A23V 2250/70 20130101; A23V 2250/702 20130101; A23V 2250/705
20130101; A23V 2250/1578 20130101; A23V 2250/16 20130101; A23V
2250/705 20130101; A23V 2250/704 20130101; A23V 2250/71 20130101;
A23V 2250/704 20130101; A23V 2250/708 20130101; A23V 2250/71
20130101; A23V 2250/156 20130101; A23V 2250/1642 20130101; A23V
2250/70 20130101; A23V 2250/708 20130101; A23V 2250/156 20130101;
A23V 2250/1588 20130101; A23V 2250/1586 20130101; A23V 2250/705
20130101; A23V 2250/712 20130101; A23V 2250/702 20130101; A23V
2250/156 20130101; A23V 2250/712 20130101; A23V 2250/71 20130101;
A23V 2250/1592 20130101; A23V 2250/705 20130101; A23V 2250/71
20130101; A23V 2250/704 20130101; A23V 2250/708 20130101; A23V
2250/712 20130101; A23V 2250/712 20130101; A23V 2250/211 20130101;
A23V 2250/70 20130101; A23V 2250/708 20130101; A61K 2300/00
20130101; A23V 2250/211 20130101; A23V 2250/70 20130101; A23V
2250/1608 20130101; A23V 2250/704 20130101; A23V 2250/156 20130101;
A23V 2002/00 20130101; A23V 2002/00 20130101; A23V 2002/00
20130101; A23L 33/16 20160801; A23V 2002/00 20130101; A61K 33/30
20130101; A23V 2002/00 20130101; A61K 33/30 20130101; A23L 33/15
20160801; A23V 2002/00 20130101; A23V 2002/00 20130101 |
Class at
Publication: |
424/647 ;
424/682; 514/52; 514/168; 514/251; 514/725; 514/276; 514/458 |
International
Class: |
A61K 033/06; A61K
031/355; A61K 033/26; A01N 031/04; A61K 031/07; A61K 031/714; A61K
031/525; A61K 031/51 |
Claims
We claim:
1. A multi-vitamin and mineral supplement for administration to a
non-lactating woman, which comprises: (a) a total daily dosage of
about 160 mg to about 240 mg of elemental calcium dosed in the form
of a pharmaceutically acceptable calcium compound; (b) a total
daily dosage of about 320 I.U. to about 480 I.U. of vitamin D; (c)
a total daily dosage of about 2,000 I.U. to about 10,000 I.U. of
vitamin A or mixtures thereof; (d) a total daily dosage of about
0.006 mg to about 0.040 mg of vitamin B.sub.12; (e) a total daily
dosage of about 8 mg to about 30 mg of vitamin B.sub.6; (f) a total
daily dosage of about 10 mg to about 40 mg of vitamin B.sub.3; (g)
a total daily dosage of about 2.7 mg to about 5.0 mg of vitamin
B.sub.2; (h) a total daily dosage of about 2.6 mg to about 4.8 mg
of vitamin B.sub.1; (i) a total daily dosage of about 24 I.U. to
about 100 I.U. of vitamin E; (j) a total daily dosage of about 6 mg
to about 42 mg of elemental iron dosed in the form of a
pharmaceutically acceptable iron compound; and (k) a total daily
dosage of about 5 mg to about 30 mg of elemental zinc dosed in the
form of a pharmaceutically acceptable zinc compound.
2. The multi-vitamin and mineral supplement of claim 1, wherein the
pharmaceutically acceptable calcium compound is selected from the
group consisting of calcium carbonate, calcium phosphate, calcium
citrate, calcium sulfate, calcium oxide, calcium hydroxide, calcium
apatite, calcium citrate-maleate, calcium lactate, calcium
levulinate and the like.
3. The multi-vitamin and mineral supplement of claim 1, which
further comprises from about 100 mg to about 500 mg of a
pharmaceutically acceptable magnesium compound.
4. The multi-vitamin and mineral supplement of claim 3, wherein the
pharmaceutically acceptable magnesium compound is selected from the
group consisting of magnesium hydroxide, magnesium sulfate,
magnesium oxide, magnesium stearate, and magnesium carbonate.
5. The multi-vitamin and mineral supplement of claim 1, wherein the
pharmaceutically acceptable iron compound is selected from the
group consisting of ferrous fumarate, ferrous sulfate, carbonyl
iron, ferrous glucomate, ferrous chloride, ferrous lactate, ferrous
tartrate, ferrous succinate, ferrous glutamate, ferrous citrate,
ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate,
iron-sugar-carboxylate complexes and the like, coated with a
pharmaceutically acceptable film forming material which permits
release of the iron in the intestine of a woman administered the
supplement.
6. The multi-vitamin and mineral supplement of claim 5, wherein the
pharmaceutically acceptable iron compound is in the form of an
extended release iron to be released over a two to twenty-four hour
period of time.
7. The multi-vitamin and mineral supplement of claim 1, wherein a
nutrient selected from the group consisting of vitamin B.sub.1,
vitamin B.sub.3, vitamin B.sub.6, vitamin C, riboflavin and
mixtures thereof is formulated for release over an extended period
of time.
8. The multi-vitamin and mineral supplement of claim 1, wherein a
nutrient selected from the group consisting of folic acid,
niacinamide, vitamin A, vitamin E, vitamin D.sub.3, vitamin
B.sub.12, biotin, pantothenic acid, copper, zinc, magnesium and
mixtures thereof is formulated for immediate release.
9. The multi-vitamin and mineral supplement of claim 1, wherein the
vitamin is a lipid-soluble vitamin.
10. The multi-vitamin and mineral supplement of claim 1, wherein
the vitamin is a water-soluble vitamin.
11. The multi-vitamin and mineral supplement of claim 10, wherein
the water-soluble vitamin is formulated for release over an
extended period of time ranging from about six hours to about
twenty-four hours.
12. The multi-vitamin and mineral supplement of claim 1, wherein a
first nutrient selected from the group consisting of thiamine,
niacinamide, pyridoxine, ascorbic acid, folic acid, iron,
riboflavin and mixtures thereof is formulated for release over an
extended period of time ranging from about six hours to about
twenty-four hours, and wherein a second nutrient selected from the
group consisting-of vitamin A, vitamin D.sub.3, vitamin B.sub.12,
biotin, pantothenic acid, copper, zinc, magnesium, potassium iodine
and mixtures thereof is formulated for immediate release.
13. The multi-vitamin and mineral supplement of claim 1, wherein
the pharmaceutically acceptable zinc compound is selected from the
group consisting of zinc oxide, zinc sulfate, and zinc
chloride.
14. The multi-vitamin and mineral supplement of claim 1, further
comprising a total daily dosage of about 60 mg to about 300 mg of
vitamin C.
15. The multi-vitamin and mineral supplement of claim 1, further
comprising a pharmaceutically acceptable carrier material.
16. The multi-vitamin and mineral supplement of claim 1, which is
administered orally once per day.
17. The multi-vitamin and mineral supplement of claim 1, wherein
the total daily dosage is divided and administered in portions
during the day.
18. The multi-vitamin and mineral supplement of claim 1, wherein
the dosage form is in the form of a multi-layer tablet comprising
an extended-release layer and an immediate-release layer.
19. The multi-vitamin and mineral supplement of claim 1, wherein
the multi-layered tablet is coated for ease of administration or
enteric coated to reduce gastric irritation.
20. The multi-vitamin and mineral supplement of claim 1, wherein
the dosage form is enteric coated and compressed into a tablet or
filled into hard or soft gelatin capsules.
21. A multi-vitamin and mineral supplement for administration to a
non-lactating woman, which comprises: (a) a total daily dosage of
about 160 mg to about 240 mg of elemental calcium dosed in the form
of a pharmaceutically acceptable calcium compound; (b) a total
daily dosage of about 320 I.U. to about 480 I.U. of vitamin D; (c)
a total daily dosage of about 2,000 I.U. to about 10,000 I.U. of
vitamin A or mixtures thereof; (d) a total daily dosage of about
0.006 mg to about 0.030 mg of vitamin B.sub.12; (e) a total daily
dosage of about 8 mg to about 40 mg of vitamin B.sub.6; (f) a total
daily dosage of about 20 mg to about 30 mg of vitamin B.sub.3; (g)
a total daily dosage of about 2.7 mg to about 4.0 mg of vitamin
B.sub.2; (h) a total daily dosage of about 2.6 mg to about 4.8 mg
of vitamin B.sub.1; (i) a total daily dosage of about 24 I.U. to
about 100 I.U. of vitamin E; (j) a total daily dosage of about 10
mg to about 42 mg of elemental iron dosed in the form of a
pharmaceutically acceptable iron compound; (k) a total daily dosage
of about 12 mg to about 30 mg of elemental zinc dosed in the form
of a pharmaceutically acceptable zinc compound; and (l) a total
daily dosage of about 95 to about 300 mg of vitamin C.
22. The multi-vitamin and mineral supplement of claim 21, which
further comprises from about 0.040 mg to about 0.060 mg of a
pharmaceutically acceptable molybdenum compound.
23. The multi-vitamin and mineral supplement of claim 21, which
further comprises from about 0.080 mg to about 0.120 mg of a
pharmaceutically acceptable chromium compound.
24. A multi-vitamin and mineral supplement for administration to a
non-lactating woman, which comprises: (a) a total daily dosage of
about 160 mg to about 240 mg of elemental calcium dosed in the form
of a pharmaceutically acceptable calcium compound; (b) a total
daily dosage of about 320 I.U. to about 480 I.U. of vitamin D; (c)
a total daily dosage of about 2,000 I.U. to about 10,000 I.U. of
vitamin A or mixtures thereof; (d) a total daily dosage of about
0.006 mg to about 0.040 mg of vitamin B.sub.12; (e) a total daily
dosage of about 8 mg to about 40 mg of vitamin B.sub.6; (f) a total
daily dosage of about 20 mg to about 30 mg of vitamin B.sub.3; (g)
a total daily dosage of about 2.7 mg to about 4.0 mg of vitamin
B.sub.2; (h) a total daily dosage of about 1 mg to about 4.8 mg of
vitamin B.sub.1; (i) a total daily dosage of about 24 I.U. to about
100 I.U. of vitamin E; (j) a total daily dosage of about 6 mg to
about 42 mg of elemental iron dosed in the form of a
pharmaceutically acceptable iron compound; (k) a total daily dosage
of about 10 mg to about 30 mg of elemental zinc dosed in the form
of a pharmaceutically acceptable zinc compound; and (l) a total
daily dosage of about 60 to about 300 mg of vitamin C; and (m) from
about 160 mg to about 240 mg of a pharmaceutically acceptable
magnesium compound.
25. A method for optimizing the health of a woman, which comprises:
administering to said woman a multi-vitamin and mineral supplement
comprising vitamins and minerals in amounts adjusted according to
varying physiological conditions of said woman over a lifetime.
26. The method of claim 25, wherein the vitamins and minerals are
selected from the group consisting of a pharmaceutically acceptable
calcium compound, vitamin D, vitamin A, B complex vitamins, vitamin
E, a pharmaceutically acceptable iron compound, a pharmaceutically
acceptable zinc compound and mixtures thereof.
27. The method of claim 25, wherein said method is for achieving
optimal regulation of growth, maintenance and repair of body tissue
during specific stages of life with minimal side effects.
28. The method of claim 25, wherein the woman is a non-lactating
woman.
29. The method of claim 28, wherein the non-lactating woman has
never given birth.
30. The method of claim 28, wherein the non-lactating woman has
given birth at least once.
31. The method of claim 25, wherein the woman is a healthy, normal
woman.
32. The method of claim 25, wherein the woman has a physical
disorder.
33. The method of claim 32, wherein the physical disorder is a
nutritional disorder.
34. The method of claim 33, wherein the nutritional disorder is
caused by a vitamin deficiency selected from the group consisting
of vitamin A deficiency, hypervitaminosis A, vitamin D deficiency
and dependency, hypervitaminosis D, vitamin E deficiency and
toxicity, vitamin K deficiency, hypervitaminosis K, essential fatty
acid deficiency, thiamine deficiency, riboflavin deficiency, niacin
deficiency, vitamin B.sub.6 deficiency and dependency, biotin
deficiency and dependancy, pantothenic acid deficiency, carnitine
deficiency, vitamin C deficiency and mixtures thereof.
35. The method of claim 33, wherein the nutritional disorder is
caused by a mineral deficiency selected from the group consisting
of phosphate depletion, iodine deficiency, fluorine deficiency,
zinc deficiency, disturbances in copper metabolism, acquired copper
deficiency, acquired copper toxicosis, inherited copper deficiency,
inherited copper toxicosis and mixtures thereof.
36. The method of claim 28, wherein the multi-vitamin and mineral
supplement is administered to meet nutritional requirements of the
non-lactating woman while attaining minimal inducement of side
effects.
37. A method for optimizing the health of a non-lactating woman,
which comprises: administering to said non-lactating woman a
multi-vitamin and mineral supplement comprising: (a) a total daily
dosage of about 160 mg to about 240 mg of elemental calcium dosed
in the form of a pharmaceutically acceptable calcium compound; (b)
a total daily dosage of about 320 I.U. to about 480 I.U. of vitamin
D; (c) a total daily dosage of about 2,000 I.U. to about 5,400 I.U.
of vitamin A or mixtures thereof; (d) a total daily dosage of about
0.006 mg to about 0.040 mg of vitamin B.sub.12; (e) a total daily
dosage of about 8 mg to about 40 mg of vitamin B.sub.6; (f) a total
daily dosage of about 10 mg to about 30 mg of vitamin B.sub.3; (g)
a total daily dosage of about 2.7 mg to about 5.0 mg of vitamin
B.sub.2; (h) a total daily dosage of about 2.6 mg to about 4.8 mg
of vitamin B.sub.1; (i) a total daily dosage of about 24 I.U. to
about 100 I.U. of vitamin E; (j) a total daily dosage of about 6 mg
to about 42 mg of elemental iron dosed in the form of a
pharmaceutically acceptable iron compound; and (k) a total daily
dosage of about 5 mg to about 30 mg of elemental zinc dosed in the
form of a pharmaceutically acceptable zinc compound.
38. The method of claim 37, wherein the multi-vitamin and mineral
supplement is administered to meet nutritional requirements of a
non-lactating woman while avoiding inducement of side effects.
39. A method for optimizing the health of a non-lactating woman,
which comprises: administering to said non-lactating woman a
multi-vitamin and mineral supplement comprising: (a) a total daily
dosage of about 100 mg to about 500 mg of elemental calcium dosed
in the form of a pharmaceutically acceptable calcium compound; (b)
a total daily dosage of about 320 I.U. to about 480 I.U. of vitamin
D; (c) a total daily dosage of about 2,000 I.U. to about 10,000
I.U. of,vitamin A or mixtures thereof; (d) a total daily dosage of
about 0.006 mg to about 0.040 mg of vitamin B.sub.12; (e) a total
daily dosage of about 8 mg to about 40 mg of vitamin B.sub.6; (f) a
total daily dosage of about 10 mg to about 30 mg of vitamin
B.sub.3; (g) a total daily dosage of about 2.7 mg to about 5.0 mg
of vitamin B.sub.2; (h) a total daily dosage of about 2.6 mg to
about 4.8 mg of vitamin B.sub.1; (i) a total daily dosage of about
24 I.U. to about 100 I.U. of vitamin E; (j) a total daily dosage of
about 6 mg to about 42 mg of elemental iron dosed in the form of a
pharmaceutically acceptable iron compound; and (k) a total daily
dosage of about 5 mg to about 30 mg of elemental zinc dosed in the
form of a pharmaceutically acceptable zinc compound.
40. The method of claim 39, which further comprises from about 160
mg to about 240 mg of a pharmaceutically acceptable magnesium
compound.
41. The method of claim 39, further comprising a total daily dosage
of about 60 mg to about 300 mg of vitamin C.
42. A method for formulating a multi-vitamin and mineral supplement
which optimizes the health of a woman, which comprises: (a)
identifying a life stage of a woman which presents specific
nutritional requirements as a result of varying physiological
conditions over a lifetime; (b) selecting specific vitamins and
minerals according to the varying physiological conditions; (c)
determining optimal amounts of each vitamin and mineral according
to the varying physiological conditions of said woman over a
lifetime; and (d) preparing a multi-vitamin and mineral supplement
containing the determined optimal amounts of each vitamin and
mineral of step (c).
43. The method of claim 42, wherein the woman is a non-lactating
woman.
Description
RELATED APPLICATION
[0001] This application is a Continuation-in-Part application of
U.S. patent application Ser. No. 08/474,071 filed Jun. 7, 1995,
which is a Continuation-in-Part application of U.S. patent
application Ser. No. 08/262,515 filed Jun. 20, 1994, the entire
contents of which are incorporated herein in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to multi-vitamin and mineral
supplements, and particularly to multi-vitamin and mineral
supplements for administration to women. The 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.
[0004] 2. Description of Related Art
[0005] 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).
[0006] 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.
[0007] Various prior patents have been directed to improving the
efficacy of iron supplements for use during pregnancy.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] Multi-vitamin and mineral formulations which are directed
specifically to woman have been disclosed in prior patents and in
the medical literature.
[0013] 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.
[0014] 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.
[0015] 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.sub.1, and low amounts of vitamin
B.sub.12 and vitamin B.sub.6.
[0016] 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.
[0017] 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.
[0018] None of the above described references is admitted to be
prior art.
SUMMARY OF THE INVENTION
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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:
[0023] (a) from about 350 mg to about 480 mg of elemental calcium
dosed in the form of a pharmaceutically acceptable calcium
compound;
[0024] (b) from about 400 I.U. to about 600 I.U. of vitamin D;
[0025] (c) from about 400 I.U. to about 8,000 I.U. of Beta
carotene, or about 3600 I.U. to about 10,000 I.U. of vitamin A or
mixtures thereof;
[0026] (d) from about 9.6 mcg to about 14.4 mcg of vitamin B12;
[0027] (e) from about 8 mg to about 12 mg of vitamin B6;
[0028] (f) from about 15 mg to about 30 mg of vitamin B3;
[0029] (g) from about 2.7 mg to about 4.0 mg of vitamin B2;
[0030] (h) from about 3.2 mg to about 4.6 mg of vitamin B1;
[0031] (i) from about 24 I.U. to about 36 I.U. of vitamin E;
[0032] (j) from about 10 mg to about 30 mg of elemental iron, dosed
in the form of a pharmaceutically acceptable iron compound; and
[0033] (k) from about 20 mg to about 30 mg of elemental zinc, dosed
in the form of a pharmaceutically acceptable zinc compound.
[0034] A multi-vitamin and mineral supplement for administration to
a non-lactating woman is also provided by the invention. This
supplement is designed to aid in fulfilling the dietary needs of
women during the period after puberty and before menopause who are
neither pregnant nor lactating. This formulation comprises:
[0035] (a) a total daily dosage of about 160 mg to about 240 mg of
elemental calcium dosed in the form of a pharmaceutically
acceptable calcium compound;
[0036] (b) a total daily dosage of about 320 I.U. to about 480 I.U.
of vitamin D;
[0037] (c) a total daily dosage of about 2,000 I.U. to about 6,000
I.U. of vitamin A or mixtures thereof;
[0038] (d) a total daily dosage of about 0.006 mg to about 0.040 mg
of vitamin B.sub.12;
[0039] (e) a total daily dosage of about 8 mg to about 26 mg of
vitamin B.sub.6;
[0040] (f) a total daily dosage of about 10 mg to about 30 mg of
vitamin B.sub.3;
[0041] (g) a total daily dosage of about 2.5 mg to about 4.0 mg of
vitamin B.sub.2;
[0042] (h) a total daily dosage of about 2.6 mg to about 4.8 mg of
vitamin B1;
[0043] (i) a total daily dosage of about 24 I.U. to about 100 I.U.
of vitamin E;
[0044] (j) a total daily dosage of about 6 mg to about 42 mg of
elemental iron dosed in the form of a pharmaceutically acceptable
iron compound; and
[0045] (k) a total daily dosage of about 12 mg to about 30 mg of
elemental zinc dosed in the form of a pharmaceutically acceptable
zinc compound.
[0046] A multi-vitamin and mineral supplement for administration to
a menopausal woman is also provided. This supplement is specially
designed to aid in fulfilling the dietary needs of women during the
transitional period marked by the cessation of menses. Menopausal
women may be asymptomatic or experience a variety of symptoms
including hot flushes. See The Merck Manual of Diagnosis and
Therapy 15th edition, 1713-1715. Most menopausal women experience
hot flushes for over a year and 25 to 50% experience hot flushes
for more than five years. The supplement for menopausal women of
the present invention comprises:
[0047] (a) from about 320 mg to about 480 mg of elemental calcium
dosed in the form of a pharmaceutically acceptable calcium
compound;
[0048] (b) from about 320 I.U. to about 480 I.U. of vitamin D;
[0049] (c) from about 250 I.U. to about 5000 I.U. of Beta-carotene,
or from about 2,000 I.U. to 6,000 I.U. of vitamin A and mixtures
thereof;
[0050] (d) from about 20 mcg to about 30 mcg of vitamin B12;
[0051] (e) from about 2.4 mg to about 3.6 mg of vitamin B6;
[0052] (f) from about 16 mcg to about 24 mg of vitamin B3;
[0053] (g) from about 1.3 mg to about 2.0 mg of vitamin B2;
[0054] (h) from about 1.2 mg to about 2.8 mg of vitamin B1;
[0055] (i) from about 7 mg to about 11 mg of elemental iron dosed
in the form of a pharmaceutically acceptable iron compound;
[0056] (k) from about 16 mg to about 24 mg of elemental zinc dosed
in the form of a pharmaceutically acceptable zinc compound;
[0057] (l) from about 40 mcg to about 60 mcg of elemental
molybdenum in the form of a pharmaceutically acceptable molybdenum
compound;
[0058] (m) from about 80 mcg to about 120 mcg of elemental chromium
dosed in the form of a pharmaceutically acceptable chromium
compound.
[0059] A method for optimizing the health of a woman is also
included in the present invention. The method comprises
administering to said woman a multi-vitamin and mineral supplement
comprising vitamins and minerals in amounts adjusted according to
varying physiological conditions of said woman over a lifetime.
[0060] A method for formulating a multi-vitamin and mineral
supplement which optimizes the health of a woman is also provided.
This method comprises:
[0061] (a) identifying a life stage of a woman which presents
specific nutritional requirements as a result of varying
physiological conditions over a lifetime;
[0062] (b) selecting specific vitamins and minerals according to
the varying physiological conditions;
[0063] (c) determining optimal amounts of each vitamin and mineral
according to varying physiological conditions of said woman over a
lifetime; and
[0064] (d) preparing a multi-vitamin and mineral supplement
containing the determined optimal amounts of each vitamin and
mineral of step (c).
[0065] Thus, the invention provides the above-described
multi-vitamin and mineral supplements for administration to
lactating, non-lactating, and menopausal women, as well as methods
both for optimizing the health of women and for preparing
formulations for same. In contrast to conventional vitamin and
mineral products, the formulations of the invention comprise
specific regimens of critical nutritional agents, in order to
better meet the physiological requirements of women and maintain
good health throughout life.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0066] As used herein, "non-lactating woman" refers to a woman who
has experienced puberty, but has not experienced menopause, and who
is not lactating and not pregnant.
[0067] "Nutrient" refers to any substance in a human or other
living organism which regulates the growth, maintenance, and repair
of body tissue, as well as any substance which provides energy or
structural material to the body.
[0068] "Essential nutrient" refers to any nutrient which is not
produced by a human or other living organism and thus must be
obtained from an external source.
[0069] "Body tissue", refers to any substance in a human or other
living organism which is composed of the cells of said human or
other organism, respectively.
[0070] "Total daily dosage" refers to the amount of any nutrient
formulated for administration during any 24 hour period of
time.
[0071] "AM dose" refers to any dose of a multi-vitamin and mineral
supplement formulated for administration in the morning hours, and
likewise, "PM dose" refers to any dose of a multi-vitamin and
mineral supplement formulated for administration in the afternoon,
evening or nighttime hours.
[0072] "Life stage" refers to a specific period of time during the
course of an individual's life.
[0073] The invention provides multi-vitamin and mineral supplements
which are tailored for women at different life stages, and
specifically for administration to lactating, non-lactating, and
menopausal women. The formulations 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 these stages of life.
[0074] According to a first aspect of the invention, a
multi-vitamin and mineral supplement for administration to a
lactating woman is provided, which comprises:
[0075] (a) from about 320 mg to about 480 mg of elemental calcium
dosed in the form of a pharmaceutically acceptable calcium
compound;
[0076] (b) from about 400 I.U. to about 600 I.U. of vitamin D;
[0077] (c) from about 400 I.U. to about 8000 I.U. of Beta-carotene,
or about 3600 I.U. to about 10,000 I.U. of vitamin A or mixtures
thereof;
[0078] (d) from about 9.6 mcg to about 14.4 mcg of vitamin B12;
[0079] (e) from about 8 mg to about 12 mg of vitamin B6;
[0080] (f) from about 15 mg to about 30 mg of vitamin B3;
[0081] (g) from about 2.7 mg to about 4 mg of vitamin B2;
[0082] (h) from 3.2 mg to about 4.8 mg of vitamin B1;
[0083] (i) from about 24 I.U. to about 36 I.U. of vitamin E;
[0084] (j) from about 10 mg to about 30 mg of elemental iron dosed
in the form of a pharmaceutically acceptable iron compound; and
[0085] (k) from about 20 mg to about 30 mg of elemental zinc dosed
in the form of a pharmaceutically acceptable zinc compound.
[0086] A particularly preferred multi-vitamin and mineral
supplement for lactating women also includes from about 160 mg to
about 240 mg of a pharmaceutically acceptable magnesium compound
and about 95 mg to about 145 mg of vitamin C.
[0087] A multi-vitamin and mineral supplement for administration to
a non-lactating woman is also provided by the invention. This
supplement is designed to specifically aid in fulfilling the
dietary needs of women during the period after puberty and before
menopause who are neither pregnant nor lactating. The invention may
be used by a non-lactating woman who has never given birth or a
non-lactating woman who has given birth one or more times. The
formulation comprises:
[0088] (a) a total daily dosage of about 160 mg to about 240 mg of
elemental calcium dosed in the form of a pharmaceutically
acceptable calcium compound;
[0089] (b) a total daily dosage of about 320 I.U. to about 480 I.U.
of vitamin D;
[0090] (c) a total daily dosage of about 2,000 I.U. to about 5,400
I.U. of vitamin A or mixtures thereof;
[0091] (d) a total daily dosage of about 0.006 mg to about 0.040 mg
of vitamin B.sub.12;
[0092] (e) a total daily dosage of about 8 mg to about 26 mg of
vitamin B.sub.6;
[0093] (f) a total daily dosage of about 15 mg to about 30 mg of
vitamin B.sub.3;
[0094] (g) a total daily dosage of about 2.7 mg to about 4.0 mg of
vitamin B.sub.2;
[0095] (h) a total daily dosage of about 2.6 mg to about 4.8 mg of
vitamin B.sub.1;
[0096] (i) a total daily dosage of about 24 I.U. to about 100 I.U.
of vitamin E;
[0097] (j) a total daily dosage of about 10 mg to about 30 mg of
elemental iron dosed in the form of a pharmaceutically acceptable
iron compound; and
[0098] (k) a total daily dosage of about 12 mg to about 30 mg of
elemental zinc dosed in the form of a pharmaceutically acceptable
zinc compound.
[0099] Preferably, the multi-vitamin and mineral supplement for
non-lactating women also includes from about 160 mg to about 240 mg
of a pharmaceutically acceptable magnesium compound and about 95 mg
to about 300 mg of vitamin C, or more preferably from about 180 mg
to about 220 mg of a pharmaceutically acceptable magnesium
compound, from about 180 to about 220 mg of vitamin C, from about
0.040 mg to about 0.060 mg of a pharmaceutically acceptable
molybdenum compound, and from about 0.080 mg to about 0.120 mg of a
pharmaceutically acceptable chromium compound.
[0100] Even more preferably, the present invention includes a
multi-vitamin and mineral supplement for administration to a
non-lactating woman which comprises:
[0101] (a) a total daily dosage of about 180 mg to about 220 mg of
elemental calcium dosed in the form of a pharmaceutically
acceptable calcium compound;
[0102] (b) a total daily dosage of about 380 I.U. to about 420 I.U.
of vitamin D;
[0103] (c) a total daily dosage of about 4,500 I.U. to about 5,500
I.U. of vitamin A or mixtures thereof;
[0104] (d) a total daily dosage of about 0.010 mg to about 0.030 mg
of vitamin B12;
[0105] (e) a total daily dosage of about 16 mg to about 24 mg of
vitamin B6;
[0106] (f) a total daily dosage of about 17 mg to about 25 mg of
vitamin B.sub.3;
[0107] (g) a total daily dosage of about 3.0 mg to about 3.8 mg of
vitamin B.sub.2;
[0108] (h) a total daily dosage of about 2.7 mg to about 3.5 mg of
vitamin B.sub.1;
[0109] (i) a total daily dosage of about 64 I.U. to about 95 I.U.
of vitamin E;
[0110] (j) a total daily dosage of about 10 mg to about 30 mg of
elemental iron dosed in the form of a pharmaceutically acceptable
iron compound; and
[0111] (k) a total daily dosage of about 14 mg to about 25 mg of
elemental zinc dosed in the form of a pharmaceutically acceptable
zinc compound.
[0112] Most preferably, the present invention includes a
multi-vitamin and mineral supplement for administration to a
non-lactating woman which comprises:
[0113] (a) a total daily dosage of about 190 mg to about 210 mg of
elemental calcium dosed in the form of a pharmaceutically
acceptable calcium compound;
[0114] (b) a total daily dosage of about 395 I.U. to about 405 I.U.
of vitamin D;
[0115] (c) a total daily dosage of about 4,750 I.U. to about 5,250
I.U. of vitamin A or mixtures thereof;
[0116] (d) a total daily dosage of about 0.016 mg to about 0.024 mg
of vitamin B.sub.12;
[0117] (e) a total daily dosage of about 18 mg to about 22 mg of
vitamin B.sub.6;
[0118] (f) a total daily dosage of about 18 mg to about 22 mg of
vitamin B.sub.3;
[0119] (g) a total daily dosage of about 3.2 mg to about 3.6 mg of
vitamin B.sub.2;
[0120] (h) a total daily dosage of about 2.8 mg to about 3.2 mg of
vitamin B.sub.1;
[0121] (i) a total daily dosage of about 70 I.U. to about 80 I.U.
of vitamin E;
[0122] (j) a total daily dosage of about 15 mg to about 24 mg of
elemental iron dosed in the form of a pharmaceutically acceptable
iron compound; and
[0123] (k) a total daily dosage of about 14 mg to about 25 mg of
elemental zinc dosed in the form of a pharmaceutically acceptable
zinc compound.
[0124] A multi-vitamin and mineral supplement for administration to
a menopausal woman is also provided, which comprises:
[0125] (a) from about 320 mg to about 480 mg of elemental calcium
dosed in the form of a pharmaceutically acceptable calcium
compound;
[0126] (b) from about 320 I.U. to about 480 I.U. of vitamin D;
[0127] (c) from about 250 I.U. to about 750 I.U. of Beta-carotene
or from about 3,600 I.U. to about 5,400 I.U. of vitamin A and
mixtures thereof;
[0128] (d) from about 20 mcg to about 30 mcg of vitamin B12;
[0129] (e) from about 2.4 mg to about 3.6 mg of vitamin B6;
[0130] (f) from about 16 mg to about 24 mg of vitamin B3;
[0131] (g) from about 1.3 mg to about 2.0 mg of vitamin B2;
[0132] (h) from about 1.2 mg to about 1.8 mg of vitamin B1;
[0133] (i) from about 70 I.U. to about 110 I.U. of vitamin E;
[0134] (j) from about 7 mg to about 11 mg of elemental iron dosed
in the form of a pharmaceutically acceptable iron compound;
[0135] (k) from about 16 mg to about 24 mg of elemental zinc dosed
in the form of a pharmaceutically acceptable zinc compound;
[0136] (l) from about 40 mcg to about 60 mcg of element molybdenum
dosed in the form of a pharmaceutically acceptable molybdenum
compound; and
[0137] (m) from about 80 mcg to about 120 mcg of elemental chromium
dosed in the form of a pharmaceutically acceptable chromium
compound.
[0138] A particularly preferred multi-vitamin and mineral
supplement for menopausal women also includes about 160 mg to about
240 mg of a pharmaceutically acceptable magnesium compound.
[0139] A method for optimizing the health of a woman is also
provided in the present invention. The method comprises
administering to said woman a multi-vitamin and mineral supplement
comprising vitamins and minerals in amounts adjusted according to
varying physiological conditions of said woman over a lifetime.
[0140] Preferably, the method comprises administering to said
non-lactating woman a multi-vitamin and mineral supplement
comprising:
[0141] (a) a total daily dosage of about 160 mg to about 240 mg of
elemental calcium dosed in the form of a pharmaceutically
acceptable calcium compound;
[0142] (b) a total daily dosage of about 320 I.U. to about 480 I.U.
of vitamin D;
[0143] (c) a total daily dosage of about 2,000 I.U. to about 5,400
I.U. of vitamin A or mixtures thereof;
[0144] (d) a total daily dosage of about 0.006 mg to about 0.040 mg
of vitamin B.sub.12;
[0145] (e) a total daily dosage of about 8 mg to about 26 mg of
vitamin B.sub.6;
[0146] (f) a total daily dosage of about 20 mg to about 30 mg of
vitamin B.sub.3;
[0147] (g) a total daily dosage of about 2.7 mg to about 4.0 mg of
vitamin B.sub.2;
[0148] (h) a total daily dosage of about 2.6 mg to about 4.8 mg of
vitamin B.sub.1;
[0149] (i) a total daily dosage of about 24 I.U. to about 100 I.U.
of vitamin E;
[0150] (j) a total daily dosage of about 6 mg to about 42 mg of
elemental iron dosed in the form of a pharmaceutically acceptable
iron compound; and
[0151] (k) a total daily dosage of about 12 mg to about 30 mg of
elemental zinc dosed in the form of a pharmaceutically acceptable
zinc compound.
[0152] A method for formulating a multi-vitamin and mineral
supplement which optimizes the health of a woman is also included.
This method comprises:
[0153] (a) identifying a life stage of a woman which presents
specific nutritional requirements as a result of varying
physiological conditions over a lifetime;
[0154] (b) selecting specific vitamins and minerals according to
the varying physiological conditions;
[0155] (c) determining optimal amounts of each vitamin and mineral
according to the varying physiological conditions of said woman
over a lifetime; and
[0156] (d) preparing a multi-vitamin and mineral supplement
containing the determined optimal amounts of each vitamin and
mineral of step (c).
[0157] It will be noted that the formulations vary in the critical
nutritional agents included and amounts thereof. For example,
because calcium is essential for the production of milk, levels of
calcium are higher for administration to lactating women than in
the non-lactating and menopausal formulations. As menopausal women
do not lose iron like women with menstrual cycles, the amount of
iron in the menopausal formulation is reduced greatly in comparison
to the formulations for lactating and non-lactating women.
Molybdenum and chromium are added to the menopausal formulation
because these agents are believed to assist the immune system,
which is a useful therapy in older women.
[0158] Various side effects may be associated with the use of
certain vitamins and minerals at various times in some individuals.
For example, women who are pregnant and experiencing morning
sickness can not tolerate excessive levels of iron. However, women
who are not pregnant are able to tolerate higher levels of iron and
it may be advantageous for them to take a formulation with more
iron. Other side effects are experienced when using niacin,
magnesium and other such vitamins and minerals, without limitation.
By recognizing the correlation between different life stages of
women and the amount of each vitamin and mineral which may induce
side effects, the present invention addresses the problem of
providing optimal supplementation of vitamins and minerals while
eliminating or at least minimizing said side effects. Accordingly,
the present invention is designed to minimize adverse effects often
experienced by women when taking vitamin and mineral supplements
while providing the optimal amount of vitamins and minerals.
[0159] The present invention is contemplated for use by women of
varying physical conditions, without limitation, including normal,
healthy women and women with a physical disorder, vitamin or
mineral deficiency, or a nutritional disorder. Non-limiting
exemplary vitamin deficiencies include vitamin A deficiency,
hypervitaminosis A, vitamin D deficiency and dependancy,
hypervitaminosis D, vitamin E deficiency and toxicity, vitamin K
deficiency, hypervitaminosis K, essential fatty acid deficiency,
thiamine deficiency, riboflavin deficiency, niacin deficiency,
vitamin B.sub.6 deficiency and dependency, biotin deficiency and
dependency, pantothenic acid deficiency, carnitine deficiency and
vitamin C deficiency. Non-limiting exemplary mineral deficiencies
include phosphate depletion, iodine deficiency, fluorine
deficiency, zinc deficiency, disturbances in copper metabolism,
acquired copper deficiency, acquired copper toxicosis, inherited
copper deficiency and inherited copper toxicosis.
[0160] Useful pharmaceutically acceptable calcium compounds
include, without limitation, any of the well-known calcium
supplements such as calcium carbonate, calcium phosphate, calcium
citrate, calcium sulfate, calcium oxide, calcium hydroxide, calcium
apatite, calcium citrate-maleate, calcium lactate, calcium
levulinate and the like. Preferably, calcium compounds selected
from the group consisting of calcium carbonate, calcium sulfate,
and mixtures thereof are employed.
[0161] Useful pharmaceutically acceptable zinc compounds include,
without limitation, zinc sulfate, zinc chloride, and zinc oxide,
with zinc sulfate being preferred.
[0162] The pharmaceutically acceptable iron compound may be chosen
from any of the well-known iron II (ferrous) or iron III (ferric)
supplements, such as ferrous fumarate, ferrous sulfate, carbonyl
iron, ferrous glucomate, ferrous chloride, ferrous lactate, ferrous
tartrate, ferrous succinate, ferrous glutamate, ferrous citrate,
ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate,
iron-sugarcarboxylate complexes and the like, without
limitation.
[0163] Preferably, the iron compound comprises a pharmaceutically
acceptable iron compound contained in a pharmaceutically acceptable
film forming material which permits release of the iron in the
stomach of a woman administered the supplement. The iron may or may
not be coated. Suitable coatings include, without limitation, any
material known in the art for forming enteric, controlled release,
or sustained release coatings, such as cellulose ethers including
hydroxypropyl methylcellulose, methylcellulose, ethylcellulose, and
carboxymethylcellulose; cellulose esters such as cellulose acetate,
cellulose acetate phthalate, and cellulose nitrate; acrylate and
methacrylate copolymers; and the like. The coated iron compound has
been found to provide increased iron bioavailability by minimizing
interaction between the iron compound and divalent cations such as
calcium in the nutritional supplement. Release of the iron in the
intestine also minimizes stomach upset. More preferably, the iron
is in the coating and is released in the stomach.
[0164] It is also possible in the present formulations to combine
various forms of extended release particles or coatings along with
immediate release particles or coatings to deliver the various
vitamins and mineral supplements over various rates of release,
without limitation. For example, certain agents such as thiamine,
niacinamide, pyridoxine, ascorbic acid, folic acid, iron and
riboflavin could be released over an extended period of time from
two hours up to 24 hours while other agents such as beta-carotene,
vitamin A, vitamin D.sub.3, vitamin B.sub.12, biotin, pantothenic
acid, copper, zinc, magnesium, potassium, iodine, chromium,
molybdenum and selenium can be administered as immediate release.
The ability to obtain extended and immediate release
characteristics is performed using well known procedures and
techniques available to the ordinary skilled artisan.
[0165] The multi-vitamin and mineral supplements-of the invention
may include additional nutritional components well-known in the
art. For example, the supplements may include elemental magnesium
dosed in the form of one or more pharmaceutically acceptable
magnesium compounds, without limitation, such as magnesium
stearate, magnesium carbonate, magnesium oxide, magnesium
hydroxide, and magnesium sulfate. Magnesium stearate is a preferred
form of the compound. The formulations may also include vitamin C,
from about 0.1 mg to about 1 mg of folic acid, from 1 mg to about 3
mg of copper, and from about 0.05 mg to about 0.25 mg of iodine.
Other nutritional agents well-known in the art may be included as
desired.
[0166] In a preferred embodiment of the formulations, the optional
vitamin C and folic acid nutritional components are coated to
provide controlled release of these agents. The techniques and
materials discussed above that are utilized to coat iron are
preferred.
[0167] Pharmaceutically acceptable copper compounds include,
without limitation, cupric oxide, cupric sulfate, or cupric
gluconate, with cupric oxide being preferred. Preferred
pharmaceutically acceptable iodine compounds include sodium or
potassium iodide, with potassium iodide being most preferred.
[0168] The vitamins in the formulation may be provided in any
source, without limitation. The amounts shown for each vitamin and
mineral indicate the actual vitamin and mineral amounts, in
milligrams (mg), in the formulations regardless of source, except
where otherwise indicated. Vitamin A may be provided in any source,
such as a preformed vitamin A compound or a vitamin A precursor, or
any combination thereof. The amount of vitamin A in the
formulations is expressed as an International Unit (I.U.) which is
a measure of vitamin activity. Therefore, the indicated amounts for
vitamin A refer to any amount of any precursor or preformed vitamin
A compound, from any source whatsoever, which would result in the
indicated amount of vitamin A activity in the body. The ability to
determine such amounts and achieve formulations containing same is
performed using well known procedures and techniques available to
the ordinary skilled artisan.
[0169] The nutritional supplements of the invention may be provided
in any suitable dosage form known in the art, without limitation.
For example, the compositions may be incorporated into tablets,
powders, granules, beads, chewable lozenges, capsules, liquids, or
similar conventional dosage forms, using conventional equipment and
techniques known in the art. Tablet dosage forms are preferred.
[0170] Furthermore, the dosage form can be in the form of a
bi-layer tablet composed of at least one extended-release layer and
at least one immediate-release layer. Also, the bi-layer tablet can
be coated for ease of administration or can be enteric coated to
reduce any gastric irritation and the unpleasant "burping" produced
by the vitamins and minerals. Also, multi-particulate design of
extended release and immediate-release components can be enteric
coated and compressed into a tablet or filled into hard or soft
gelatin capsules.
[0171] When preparing dosage forms incorporating the compositions
of the invention, the nutritional components are normally blended
with conventional excipients such as binders, including gelatin,
pregelatinized starch, and the like; lubricants, such as
hydrogenated vegetable oil, stearic acid, and the like; diluents,
such as lactose, mannose, and sucrose; disintegrants, such as
carboxymethyl cellulose and sodium starch glycolate; suspending
agents, such as povidone, polyvinyl alcohol and the like;
absorbent, such as silicon dioxide; preservatives, such as
methylparaben, propylparaben, and sodium benzoate; surfactants,
such as sodium lauryl sulfate, polysorbate 80, and the like; and
colorants, such as F.D. & C dyes and lakes.
[0172] For preparing compositions from the compounds described by
this invention, inert, pharmaceutically acceptable carriers can be
used which are either solid or liquid. Solid form preparations
include powders, tablets, dispersible granules, capsules, and
cachets. A solid carrier can be one or more substances which may
also act as diluents, flavoring agents, solubilizers, lubricants,
suspending agents, binders or tablet disintegrating agents; it can
also be encapsulating material. In powders, the carrier is a finely
divided solid which is in admixture with the finely divided active
compounds. In the tablet the active compound is mixed with carrier
having the necessary binding properties in suitable proportions and
compacted in the shape and size desired. The powders and tablets
preferably contain from 5 or 10 to about 90 percent of the active
ingredient. Suitable solid carriers are magnesium carbonate,
magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch,
gelatin, tragacanth, methylcellulose, sodium
carboxymethylcellulose, a low melting wax, coca butter, and the
like. The term "preparation" is intended to include the formulation
of the active compounds with encapsulating material as carrier
providing a capsule in which the active component (with or without
other carriers) is surrounded by carrier, which is thus in
association with it. Similarly, cachets are included. Tablets,
powders, cachets, and capsules can be used a solid dosage forms
suitable for oral administration. Liquid form preparations include
solutions, suspensions, and emulsions. As an example, water or
water/propylene glycol solutions for parenteral injection may be
used. Liquid preparations can also be formulated in solution in
aqueous polyethylene glycol solution. Aqueous solutions suitable
for oral use can be prepared by dissolving the active component in
water and adding suitable colorants, flavors, stabilizing and
thickening agents as desired. Aqueous suspensions suitable for oral
use can be made by dispersing the finely divided active component
in water with viscous material, i.e., natural or synthetic gums,
resins, methylcellulose, sodium carboxymethylcellulose, and other
well-known suspending agents.
[0173] Also included are solid form preparations which are intended
to be converted, shortly before use, to liquid form preparations
for either oral or parenteral administration. Such liquid forms
include solutions, suspensions, and emulsions. These particular
solid form preparations are most conveniently provided in unit dose
form and as such are used to provide a single liquid dosage unit.
Alternately, sufficient solid may be provided so that after
conversion to liquid form, multiple individual liquid doses may be
obtained by measuring predetermined volumes of the liquid form
preparation as with a syringe, teaspoon, or other volumetric
container. When multiple liquid doses are so prepared, it is
preferred to maintain the unused portion of said liquid doses at
low temperature (i.e., under refrigeration) in order to retard
possible decomposition.
[0174] The solid and liquid forms may contain, in addition to the
active addition to the material, flavorants, colorants,
stabilizers, buffers, artificial and natural sweeteners,
dispersants, thickeners, solubilizing agents, and the like. The
liquid utilized for preparing the liquid form preparation may be
water, isotonic water, ethanol, glycerine, propylene glycol, and
the like as well as mixtures thereof. Naturally, the liquid
utilized will be chosen with regard to the route of administration,
for example, liquid preparations containing large amounts of
ethanol are not suitable for parenteral use.
[0175] Preferably, the preparations are in unit dosage form. In
such form, the preparation is subdivided into unit doses containing
appropriate quantities of the active components. The unit dosage
form can be a packaged preparation, the package containing discrete
quantities of preparation, for example, packeted tablets, capsules,
and powders in vials or ampoules. The unit dosage form can also be
a capsule, cachet, or tablet itself or it can be the appropriate
number of any of these in packaged form.
[0176] The quantity of active compound in a unit dose of
preparation may be varied according to the particular application
and the potency of the active ingredients.
[0177] Determination of the proper dosage for a particular
situation is well within the skill of the art. For convenience, the
total daily dosage may be divided and administered in portions
during the day if desired or at one time, morning, afternoon, or
night as well as biphasic, triphasic, etc. Moreover, the portion
administered in one dose during a day need not be equal to all or
any other doses administered during a day.
[0178] For example,, if the total daily dosage is divided into two
different doses, such as an AM and a PM dose, then one vitamin,
such as vitamin B.sub.6, may be present in a lesser amount in the
AM dose than in the PM dose. Several or all of the vitamins and/or
minerals may be treated in such a manner. The amount of a vitamin
and mineral in each dose is determined as the amount which will
achieve optimal or maximal efficacy with minimal side effects. The
use of such unequal doses during the course of a day may apply to
the entire formulation, or any individual vitamin or mineral in
said formulation. Moreover, it is believed that the use of unequal
doses increases the bioavailability of some or all of the nutrients
provided in the formulations.
[0179] Controlled and uncontrolled release formulations, as well as
sustained release, extended release, timed release, delayed release
and other such formulations, without limitation, are contemplated
for use with the present invention.
[0180] Although the products of the invention are preferably
intended for administration to humans, it will be understood that
the formulation may also be utilized in veterinary therapies for
other animals.
[0181] The following examples are given to illustrate the invention
but are not deemed to be limiting thereof. All amounts specified in
the application are based on milligrams (mg) unless otherwise
indicated. The term "I.U." represents International Units.
EXAMPLE 1
[0182] Preparation of Multi-Vitamin and Mineral Supplements
[0183] The following compositions were used to prepare
multi-vitamin and mineral supplements for administration to
lactating, non-lactating, and menopausal women:
1TABLE I Component Lactating Non-Lactating Menopausal Calcium, mg
320-480 160-240 320-480 Vitamin D, I.U. 400-600 320-480 320-480
Vitamin B12, mg 0.006-0.015 0.006-0.040 0.020-0.030 Vitamin B6, mg
8-40 8-40 8-40 Vitamin B3, mg 18-30 15-30 10-40 Vitamin B2, mg
2.7-5.0 2.7-5.0 2.7-5.0 Vitamin B1, mg 3.2-4.8 2.6-4.8 1-3 Vitamin
E, I.U. 20-40 24-100 70-110 Iron, mg 28-43 6-42 7-11 Zinc, mg 20-30
12-30 10-30 Vitamin C, mg 60-300 60-300 60-300 Molybdenum, mg
0.020-0.030 0.040-0.060 0.040-0.060 Chromium, mg 0.040-0.060
0.080-0.120 0.080-0.120 Vitamin A, I.U. 2,000-10,000 2,000-10,000
2,000- 10,000 Potassium, mg. 40-60 40-60 64-96 Pantothenic 12-18
8-12 8-12 Acid, mg Folic Acid, mg 0.8-1.2 0.8-1.2 0.8-1.2 Biotin,
mcg 0.040-0.060 0.240-0.360 0.240-0.360 Copper, mg 1.6-2.4 1.6-2.4
1.6-2.4 Iodine, mg 0.120-.180 0.120-0.180 0.120-0.180 Magnesium, mg
160-240 160-240 160-240
[0184] Tablets incorporating the above formulations were prepared
using conventional methods and materials known in the
pharmaceutical art. The resulting nutritional supplement tablets
were recovered and stored for future use.
EXAMPLE 2
[0185] The following compositions were used to prepare
multi-vitamin and mineral supplements for administration to
lactating, non-lactating and menopausal women.
2TABLE II Component Lactating Non-Lactating Menopausal Calcium, mg
400 200 400 Vitamin D, I.U. 500 400 400 Vitamin B12, mg 0.012 0.020
.025 Vitamin B6, mg 10 20 3 Vitamin B3, mg 25 20 20 Vitamin B2. mg
3.4 3.4 1.7 Vitamin B1, mg 4.0 3.0 1.5 Vitamin E. I.U. 30 75 90
Iron, mg 36 18 9 Zinc, mg 25 15 20 Vitamin C, mg 120 200 240
Potassium, mg -- 25 80 Pantothenic Acid, mg 15 10 10 Folic Acid, mg
1.0 1.0 0.5 Biotin. mg 0.050 0.03 0.300 Cooper, mg 2 2 2 Iodide, mg
0.150 0.150 0.150 Magnesium, mg 200 200 200
[0186] The invention being thus described, it will be apparent that
the same may be varied in many ways. Such variations are not to be
regarded as a departure from the spirit and scope of the invention,
and all such modifications are intended to be within the scope of
the appended claims.
* * * * *