Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2000-03-07
2001-06-19
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S464000, C424S474000, C424S489000, C424S195110
Reexamination Certificate
active
06248307
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a composition having at least one herbal compound and at least one homeopathic drug that is useful for treating symptoms associated with menopause. Methods of preparing the composition and methods of treating, alleviating or otherwise mitigating the menopausal symptoms are the subject of the present invention.
BACKGROUND AND SUMMARY OF THE INVENTION
Menopause is the termination of the menstrual cycle in woman, and is caused by the changes in hormone levels that occur naturally over time. Estrogen and progesterone are the key hormones involved in these changes, but other factors may be involved as well.
The onset of menopause is associated with many symptoms will vary between women, but will generally include one or more of the following symptoms: hot flashes, numbness, tingling, insomnia, nervousness, depression, vertigo, fatigue, arthralgia, myalgia, headaches, palpitations, and formication. Osteoporosis is another condition associated with the onset of menopause, and leads to decreased bone density and an increase in fractures and breaks.
Menopausal symptoms are related primarily to the change in estrogen levels, and estrogen replacement therapy, either with or without progesterone, is a common method of providing some relief from menopausal symptoms. However, hormone replacement therapy is associated with many adverse effects, potentially leading to problems are potentially more troublesome than the menopausal symptoms themselves. Calcium may be added to the regimen to combat or prevent the effects of osteoporosis.
Other, methods for treating the symptoms associated with menopause are known. For instance, there are several herbal remedies that are used to alleviate menopausal symptoms; homeopathic remedies are known as well. Presently available formulations consist of either herbs or homeopathics; combination formulations of herbal and homeopathics are not presently believed to be available. One example of a commercially available homeopathic remedy for treatment of menopausal symptoms is Hyland's Menopause Tablets, which contains a specific combination of Amyl Nitrosum,
Sanguinaria Canadensis
and
Lachesis Mutus
in a lactose base. Other known homeopathic products useful in treating various conditions are described in the Homeopathic Pharmacopeia of the United States(HPUS).
Despite the advances in the art, there is a need for improved therapies for treating menopausal symptoms. Thus, it is an object of the present invention to provide improved formulations for the treatment and prevention of menopausal symptoms.
It is also an object of the present invention to provide improved methods for preparing formulations, particularly oral solid dosage forms, useful in treating menopausal symptoms.
It is also an object of the present invention to provide improved methods of treating, preventing or otherwise mitigating the symptoms associated with menopause.
These objects and others are achieved by the present invention, which related in part to an oral solid dosage form that includes from about 1 to about 99 wt. % of a therapeutically effective amount of at least one herb that renders a therapeutic effect on menopausal symptoms, and from 1 to about 99 wt. % of at least one homoeopathic component that renders a therapeutic effect on menopausal symptoms, wherein the weight percent is based on the total amount of the homeopathic and herbal components. For purposes of this invention, rendering a therapeutic effect on menopausal symptoms is defined as reducing the severity or incidence, preventing, or otherwise alleviating at least one symptom associated with menopause. In preferred embodiments, the herbal component will include
Cimicifuga Racemosa
, and the homeopathic component will include Amyl Nitrate. In other preferred embodiments, the oral solid dosage form provides a sustained release of one or more active components in vivo for a time period of from 6 to about 24 hours.
In a preferred embodiment, the oral solid dosage form also contains a calcium salt, e.g. calcium citrate. When calcium is present, it is preferred that at least 200 mg calcium ion be provided by the dosage form. Preferred dosage forms include tablets and capsules.
The present invention also relates to a method of preparing an oral dosage form for the treatment of menopausal symptoms. The dosage forms may be prepared by admixing the requisite amounts of homeopathic drug and herbal components, together with the calcium salt any pharmaceutical excipients, and dividing the mixture into unit doses containing an appropriate amount of the admixture to treat menopausal symptoms when administered to a patient in need of such treatment.
The present invention also relates to a method of treating menopausal symptoms by administering a unit dose of the combination of the present invention to a patient in need of treatment for menopausal symptoms.
The invention is described in more detail in the description that follows.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The oral solid dosage forms of the present invention are a therapeutically active blend of herbs and homeopathic drugs that provide relief for patients suffering from menopausal symptoms. The herbal component preferably comprises from about 1 to about 99% by weight of the combined weight of the herbal and homeopathic components form, and preferably between about 25 to 75% by weight.
Any herb that is capable of providing relief from menopausal symptoms may be included in the dosage form, provided it is not incompatible with the other ingredients. A non-limiting list of suitable herbs that may be used in accordance with the present invention include wild yams, black cohosh, and the like. The herb will be present in an amount ranging from 1 to about 99 wt % of the combined weight of the herb(s) and homeopathics, preferably between about 25 and 75% by weight.
It is preferred that black cohosh is included as one of the herbal components. Also known as black snakeroot and actaeae racemosae radix, black cohosh consists of the dried roots and rhizomes of
Cimicifuga racemosa
. Pharmacologic studies have shown that black cohosh contains several compounds which may contribute to its activity, including triteipene glycosides, aglycones, isofalvones, and aromatic acids. It has been demonstrated that black cohosh may exert its effect on menopausal woman by reducing the serum concentration of the pituitary hormone luteinizing hormone (LH) (Duker, E. M. et al., Effects of extract from
Cimicifuga racemosa
on gonadotropin release in menopausal women and ovariectomized rats.
Planta Medica,
57:420-424.) It is preferred that from about 40 to about 3000 mg of the dried root and rhizome be provided, daily, preferably from 100 to 400 mg. Alternatively, a sufficient amount of black cohosh is provided to deliver between 2 and 10 milligrams of triterpene glycosides and preferably from about 3 to about 5 mg daily. Thus, an equivalent amount of black cohosh extract may be included. Most preferably, a sufficient amount of black cohosh or equivalent is provided to provide 4 mg tritrerpene glycosides per day. The dosage form preferably contains 2 mg triterpene glycoside, and two dosage forms will be administered per day. In another preferred embodiment, the dosage form provides 1 mg triterpene glycosides and four dosage forms are administered daily.
The homeopathic drug included in the dosage form will comprise from about 1 to about 99% by total weight of the herbal component and the homeopathic component. Suitable homeopathics that may be included in the oral solid dosage form of the present invention include Amyl Nitrate,
Sanguinaria Canadensis, Lachesis Muta,
and the like. Amyl nitrate (amyl nitrosum) is a mixture of the nitrite esters of 3-methyl-1-butanol and 2-methyl- 1-butanol which has been reported to provide relief from certain menopausal symptoms, including hot flashes. It contains not less than 85% and not more than 103% C
5
H
11
NO
2
. The dosage form will typically include from about 2× (10
−2
M) to 10&
Borneman John P.
Phillips Mark S.
Fulbright & Jaworski LLP
Page Thurman K.
Pulliam Amy E
Standard Homeopathic Company
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