Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-09-30
2002-11-12
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S899000, C424S484000
Reexamination Certificate
active
06479545
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
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.
2. Description of the Related Art
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 much more than simply the loss of reproductive capability, as it is also associated with a number of acute and chronic conditions. Menopausal syndrome consists of a number of varying and often highly distressing symptoms resulting from hormonal imbalance and nutritional deficiency in the female body.
Hot flashes and sweating secondary to vasomotor instability affect 75% of women. Psychologic and emotional symptoms of fatigue, insomnia, irritability and nervousness are common. Lack of sleep due to disturbance by recurring hot flashes contributes to fatigue and irritability. Dizziness, parenthesis and cardiac symptoms of palpitations and tachycardia may also occur; the incidence of heart disease increases. Other common symptoms include nausea, constipation, diarrhea, arthralgia and myalgia.
The Merck Manual,
1793 (16
th
Ed. 1992).
Menopause is also characterized by osteoporosis, or loss of bone density, resulting in increased bone fractures and vertebral column collapse. Bone loss begins around age 35. This loss accelerates during menopause, which generally occurs around age 45 to 55. Bone mass losses average 1-2% each year after menopause. Primary sites are the vertebrae, which show anterior collapse resulting in stooping and backache, the hips and the wrist.
The Merck Manual
1793(16
th
Ed. 1992). Osteoporosis develops over decades and is related to peak bone mass, as well as to the degree of bone loss.
Estrogen replacement therapy has been used to relieve the symptoms of menopause.
The Merck Manual
1793(16
th
Ed. 1992). 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. Estrogen has also been implicated in certain endometrial cancers. 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. Adequate nutritional intake is also necessary.
Appropriate nutritional intake is increasingly important to menopausal women. For example, adequate calcium intake prevents osteoporosis. Moreover, certain vitamins and minerals enhance calcium absorption and utilization. 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. Fatty acids are essential in supporting life's activities as the body derives most of its energy from triglycerides, a molecule of glycerol with three fatty acids. Linoleic acid and linolenic acid, in particular, are two fatty acids which are indispensable to body functions. The inclusion of these two fatty acids in nutritional supplements is of particular significance because they are not produced by the body and must be supplied through food. However, conventional nutritional supplements fail to include these two fatty acids.
The use of fatty acids in various forms and for various purposes has been previously disclosed. Horrobin et al. disclose a method of prevention or treatment of endometriosis wherein effective amounts of one or both gamma-linolenic acid and/or dihomo-gamma-linolenic acid are administered to women. Specifically, the fatty acids may be administered in the form of the acid itself or as an ester, amide, salt or any other functional derivative capable of being converted to the acid within the body and may be from natural or synthetic sources.
Maxson et al., U.S. Pat. No. 4,900,734, disclose a pharmaceutical composition containing estradiol and progesterone for oral administration. Specifically, the pharmaceutical composition comprises estradiol dissolved in an oil vehicle containing a suspension of micronized progesterone. Further, the oil vehicle is high in glycerides of polyunsaturated fatty acids. Specifically, linoleic and linolenic acids are disclosed as particularly effective polyunsaturated fatty acids. The combined administration of these steroids is disclosed as being useful for replacement hormone therapy in the treatment of menopausal women.
Cohen, U.S. Pat. No. 4,945,103, discloses a method for treating women who suffer from premenstrual syndrome (PMS) which comprises administration of melatonin in sufficient doses to relieve symptoms associated with PMS. Specifically, Cohen discloses that progestogen can be administered in combination with melatonin. Further, melatonin can be administered to women orally, parenterally or in the form of an implant. Cohen specifically discloses that PMS may be linked to a nutritional deficiency in either vitamin B-complex, especially vitamin B6 (pyroxidine), or essential fatty acids, especially linolenic acid.
Horrobin, U.S. Pat. No. 5,380,757, discloses a method of treatment of vulvar dystrophy and/or vaginal dryness, which medicament comprises gamma-linolenic (GIA) and/or dihomo-gamma-linolenic acid (DGIA), optionally in association with other essential fatty acids of the n-6 or n-3 series. Horrobin discloses that deficiency of linoleic acid in the diet may produce atrophy and hyperkeratosis of the skin.
Miyamoto et al., U.S. Pat. No. 5,461,170, disclose a glyceride preparation having a branched saturated fatty acid and/or myristic acid residues for use in liquid oils and/or solid cosmetics of the same. Specifically, Miyamoto et al. disclose a polyol fatty-acid ester having mixed acid group produced by reacting a partial ester of a polyol and a branched fatty acid with a straight chain fatty acid or a lower alcohol ester thereof in the presence of a lipase. The obtained glyceride mixture contains a large amount of diglyceride having a branched, saturated fatty acid group and a straight chain, fatty acid group. The reference does not specifically disclose either linoleic or linolenic acid and/or menopause.
Sultenfuss, U.S. Pat. No. 5,514,382, discloses a daily vitamin and mineral supplement for women comprising vitamin A, beta-carotene, niacin, riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, biotin, paraaminobenzoic acid, inositol, choline, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, selenium, zinc, and bioflavonoid. For women over 40 years of age, iron is optionally included.
Shylankevich, U.S. Pat. No. 5,569,459, discloses compositions containing various vitamins, minerals and herbal extracts that can be used for alleviation of premenstrual syndrome, menopausal disorders, and stimulating estrogen production. Specifically, the invention relates to such pharmaceutical compositions and dietary supplements that contain natural soybean phytoestrogens of the isoflavone group.
Vitamins For Women disclose a Calcium/Vitamin/Mineral supplement program for women over forty. Specifically, the “over forty” formula discloses a composition containing ingredients which come in day and/or night formulas that “assure better utilization and absorption.”
Physicians's Desk Reference for Nonprescription Drugs,
(9
th
Ed., 1988) 718.
However, the previously disclosed formulations are deficient for various reasons. In particular, none of the previously disclose
Hermelin Marc S.
Kirschner Mitchell I.
Levinson R. Saul
Drugtech Corporation
Goldberg Joshua B.
Nath Gary M.
Nath & Associates PLLC
Webman Edward J.
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