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Formulation for menopausal women

a menopausal woman and formulation technology, applied in the field of formulation for menopausal women, can solve the problems of increased bone fractures, fatigue and irritability, increased bone fractures, and vertebral column collapse, so as to reduce the possibility of premature menopause and reduce the risk of premature menopaus

Inactive Publication Date: 2009-03-12
DRAGTEK CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a composition for administration to menopausal women that addresses the deficiencies of current nutritional supplements. The composition contains a combination of essential fatty acids, calcium, folic acid, and optionally other components in specific ratios. The weight ratio of the essential fatty acids to the calcium compound is about 1:0.4 to 2500. The composition is designed to provide optimal nutritional support for women during the menopausal transition period."

Problems solved by technology

Lack of sleep due to disturbance by recurring hot flashes contributes to fatigue and irritability.
Menopause is also characterized by osteoporosis, or loss of bone density, resulting in increased bone fractures and vertebral column collapse.
However, estrogen therapy is not without its limitations.
In some instances the side effects of estrogen therapy can be quite severe.
These side effects include increased risk of certain cancers, such as breast cancer.
Although treatments with progestin have been shown to counter these adverse side effects, postmenopausal women treated with such an estrogen-progestin regimen frequently experience undesirable uterine bleeding.
Further, hormone therapy alone is insufficient to meet the varied and heightened nutritional requirements of a woman during this phase in her life.
However, while vitamin and mineral supplements providing calcium for women is known in the art, conventional supplements fail to meet other nutritional requirements of menopausal women.
Specifically, conventional supplements lack certain fatty acids which are especially useful to treat symptoms of fatigue or tiredness commonly experienced by a woman undergoing menopause.
However, conventional nutritional supplements fail to include these two fatty acids.
Further, the oil vehicle is high in glycerides of polyunsaturated fatty acids.
However, the previously disclosed formulations are deficient for various reasons.
In particular, none of the previously disclosed formulations contain critical components, such as essential fatty acids or calcium, in amounts specifically tailored to meet the needs of premenopausal and menopausal women.
Moreover, the previously disclosed formulations fail to disclose the significance of the proportion of the various components to one another.

Method used

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  • Formulation for menopausal women

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0173]The following formulations are used to prepare compositions for administration to premenopausal and menopausal women:

ComponentDoseUnitsVitamin A (Beta Carotene)5,000I.U.Vitamin D400I.U.Vitamin E400I.U.Vitamin C100I.U.Vitamin B120mg.Vitamin B220mg.Vitamin B625mg.Vitamin B1250mcg.Vitamin B3100mg.Folic Acid1.0mg.Calcium Carbonate1,200mg.Copper2mg.Zinc15mg.Selenium65mcg.DHA / Linolenic / Linoleic Acid50 / 25 / 25mg.

[0174]It would be anticipated that upon administration of the above composition, an average normal menopausal woman would be expected to have reduced incidence of nutritional deficiency and reduced menopausal-related symptoms or disorders when compared to an average normal menopausal woman following a conventional nutritional regimen.

example 2

[0175]The following compositions are for administration to premenopausal women and menopausal women in accordance with the regimen indicated below:

RegimenComponentDoseFirst MorningCalcium Carbonate350mgTablet (orange):B Complex55mgSecond MorningCalcium Carbonate350mgTablet (white):Vitamin A3,000IUVitamin C100IUVitamin D400IUSelenium65mcgZinc15mgCooper2mgEvening TabletCalcium Carbonate350mgB Complex110mgVitamin A2,000IUFolic Acid1mgEvening CapsuleVitamin E400IUDHA50mgLinolenic Acid25mgLinoleic Acid25mgCalcium Carbonate150mg

[0176]It would be anticipated than upon following the above regimen, an average normal menopausal woman would be expected to have reduced incidence of nutritional deficiency and reduced menopausal-related symptoms or disorders when compared to an average normal menopausal woman following a conventional nutritional regimen.

example 3

[0177]A soft gelatin supplement in accordance with the compositions of Examples 1 and 2 above, may be prepared, by first combining mineral oil and soybean oil in a first vessel and blending it to form a uniform oil mixture, heating the oil mixture to 45 degrees Celsius, and then adding propylene glycol. In a second vessel preheated to 70 degrees Celsius, yellow beeswax and soybean oil are added and blended until a uniform wax mixture is formed. The wax mixture is cooled to 35 degrees Celsius and then added to the oil mixture. To this combined oil and wax mixture, folic acid, vitamin B6, iron, magnesium, and calcium are then added and blended together to form a uniform biologically active mixture. The mixture is then cooled to 30 degrees Celsius to form a viscous biologically active core composition, after which time the composition is ready for encapsulation in a soft gelatin shell.

[0178]A soft gelatin shell is prepared by heating purified water in a suitable vessel and then adding ...

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Abstract

The present disclosure relates to novel compositions which provide improved nutritional support for premenopausal and menopausal women and / or relief from systems associated with menopause, as well as prophylactic effects, and methods for using same.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation application of co-pending U.S. patent application Ser. No. 11 / 023,871 filed Dec. 22, 2004, said application being a continuation of U.S. patent application Ser. No. 10 / 131,236, filed Apr. 25, 2002; said application being a continuation of U.S. patent application Ser. No. 09 / 409,059, filed Sep. 30, 1999 now issued as U.S. Pat. No. 6,479,545, the entire contents of which are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]The present invention is directed to novel compositions for use by premenopausal women and menopausal women for the purpose of providing improved nutritional support and / or relief from the symptoms of menopause, as well as to methods for using same.[0003]Menopause, the transition from the reproductive stage to the non-reproductive stage of a woman's life, is characterized primarily by the cessation of menstruation. However, menopause has come to signify...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K33/06A61K31/202A61P3/02A23L1/30A61K9/10A23L1/304A23L33/15A61K9/16A61K9/20A61K9/48A61K31/07A61K31/138A61K31/194A61K31/198A61K31/201A61K31/355A61K31/375A61K31/4168A61K31/4415A61K31/51A61K31/525A61K31/565A61K31/566A61K31/567A61K31/57A61K31/59A61K31/616A61K31/663A61K31/714A61K33/04A61K33/10A61K33/18A61K33/24A61K33/26A61K33/30A61K33/32A61K33/34A61K35/32A61K35/56A61K35/618A61K38/23A61K45/06A61P1/08A61P1/10A61P1/12A61P5/30A61P5/34A61P9/00A61P15/00A61P15/12A61P19/02A61P21/00A61P25/02A61P25/20A61P25/22A61P25/24A61P29/02
CPCA23L1/3008A23L1/302A23L1/304A23V2002/00Y10S514/899A61K45/06A23V2250/211A23V2250/70A23V2250/156A23V2250/1868A23V2250/1874A23V2250/1872A23V2250/71A23V2250/712A23V2250/708A23V2250/704A23V2250/1578A23V2250/1588A23V2250/1642A23V2250/1626A23V2250/18A23V2250/30A23V2250/1592A23V2250/161A23V2200/224A23V2250/5432A23L33/12A23L33/15A23L33/16A61P1/08A61P1/10A61P1/12A61P15/00A61P15/12A61P19/02A61P21/00A61P25/02A61P25/20A61P25/22A61P25/24A61P29/02A61P3/02A61P5/30A61P5/34A61P9/00A61K33/06
Inventor LEVINSON, R. SAULHERMELIN, MARC S.KIRSCHNER, MITCHELL I.
Owner DRAGTEK CORP
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