Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2002-09-30
2004-08-03
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S434000, C424S435000, C518S721000
Reexamination Certificate
active
06770263
ABSTRACT:
TECHNICAL FIELD
This invention relates to compositions and methods for treating aches and/or pains, and more particularly to herbal compositions for pain relief associated with headaches.
BACKGROUND
Aches, pains, and discomfort are common problems for the sick, aged, and injured. For example, headaches are a common problem worldwide with the most severe being associated with migraine headaches. Women are three times more likely to be affected by migraine headaches than men. Migraine headaches occur in approximately 12% of the world's population. Thus, in the United States there are approximately 30 million people who suffer from this affliction each year. Current treatments for migraines and headaches in general utilize oral compositions that make their way through the gastrointestinal tract to the circulatory system and ultimately across the blood brain barrier. Such a traversal of the various organs in the body results in a depletion of the active ingredients in such medications through metabolism in the liver and breakdown in the stomach and intestine by acids and enzymes. Other treatments include subcutaneous injections and nasal sprays. Subcutaneous injections are painful and difficult to administer. The use of some migraine treatments such as “triptans”, which are selective seratonin agonists, may cause serious side effects and are contra-indicated with certain conditions such as hypertension (Bartleson, J D, Mayo Clin. Proc., 74:702-708, 1999; Pauwels and John, Clin. Neuropharmacol., 22(3):123-136, 1999). In addition, the acute treatment of migraines with many abortive therapies may result in a “rebound effect” (Pauwels and John, Clin. Neuropharmacol., 22(3):123-136, 1999). Furthermore, migraine headaches are typically treated after they have become painful, i.e., the treatment is often ineffective in eliminating and/or in preventing the onset of the migraine headache.
The exact cause of migraine headaches is unknown. Symptoms associated with such headaches include recurring unilateral throbbing headaches, only partially preceded by a warning visual aura, nausea, vomiting, and photosensitivity. It is believed that migraines may be at least partially caused by cerebral arterial vasospasms and general cerebral inflammation. Serotonergic circuitry in the brainstem may also be involved along with activation of the trigeminovascular pain system.
SUMMARY
The invention provides a composition comprising an aqueous medium having dispersed or dissolved therein an herbal medicinal agent and/or an analgesic agent, wherein the composition is effective when delivered to the mucosal membrane.
The invention provides a composition comprising an aqueous medium having dispersed or dissolved therein an analgesic such as, for example, white willow bark, aspirin, ibuprofen, naproxen, and any combination thereof in an amount of from about 0.001% to about 0.35% by weight; and feverfew dried plant (e.g., leaf) particles dispersed or dissolved in the aqueous medium having a concentration of about 0.001 to 2.0% in the aqueous medium. In one aspect, the feverfew is present at a concentration of about 0.01% to 0.35%. Typically the aqueous medium will comprise water. The composition may further comprise an agent selected from the group consisting of butterbur extract, goldenseal extract, dandelion extract, polyporous extract, ascorbic acid, potassium sorbate, and any combination thereof, as well as a material selected from the group consisting of a surfactant, a vitamin, a vitamin derivative, a wetting agent, a preservative, and an emulsifier (e.g., glycerin).
The invention also provides a method of treating a subject disposed to a headache, toothache, earache, joint pain, backache, abdominal cramps, and the like comprising administering a composition as provided above.
The invention provides a method of treating as subject disposed to a disorder of aches and/or pains by administering to a mucus membrane of the subject a composition comprising an aqueous medium; an analgesic such as, for example, white willow bark, aspirin, ibuprofen, and naproxen in an amount of from about 0.001% to about 0.35% by weight; and feverfew dried plant (e.g., leaf) particles dispersed or dissolved in the aqueous medium having a concentration of about 0.001 to 2.0% in the aqueous medium, wherein the composition is administered in an amount effective to treat or reduce the severity of the aches and/or pains. The method includes administering the composition to the mucus membrane of the sinus cavity and the mouth (e.g., the sublingual space). Thus, the invention can be used to treat headaches (including migraines), pre-menstrual syndrome (PMS), back pain, earaches, toothaches, and sports-associated pains or aches.
The invention further provides a composition comprising a sprayable aqueous medium having dispersed or dissolved therein an analgesic such as, for example, white willow bark, butterbur extract, aspirin, ibuprofen, and naproxen in an amount of from about 0.001% to about 0.35% by weight of the aqueous carrier, wherein the sprayable aqueous medium is tolerant to mucus membranes.
Other features, objects, and advantages of the invention will be apparent from the description and from the claims.
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Krivoy et al., “Effect of Salicis Cortex Extract on Human Platelet Aggregation”,Planta Med., 67 (2001), pp. 209-212.
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Fish & Richardson P.C.
Haghighatian Mina
NatureWell, Incorporated
Page Thurman K.
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