Pain reliever and method of use

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...

Reexamination Certificate

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C514S825000, C514S887000, C424S077000, C424S078050

Reexamination Certificate

active

06812254

ABSTRACT:

BACKGROUND OF THE INVENTION
In one aspect, this invention relates to a composition of matter useful for treating bodily pains and discomforts. In another aspect, this invention relates to a method for treating bodily pains and discomforts. In yet another aspect, this invention relates to formulating a pain and discomfort reliever.
Arthritis is medically termed as an inflammation of a joint or joints and is one of a number of diseases and disorders of the skeleton and body system. Arthritis arises from many causes, some well-defined, some still unknown, and it is treated in many different ways. There are two common types, the first of which is inflammatory, of which rheumatoid arthritis is the most commonly acknowledged and a non-inflammatory, second type, most commonly represented by degenerative joint disease, or wear and tear arthritis. Inflammatory arthritis is a disease not of the joints alone but of the whole bodily system, in particular, the connective tissues of the body. It is an auto-immmune disease, where the body's immune system attacks its own host (i.e. itself) and produces inflamation. Degenerative joint disease is a chronic joint disease, often occurring in more elderly people. In both cases many manifestations are similar. The joints, whether singly or in multiples, are affected. The joints may become swollen, warm, deformed, gnarled, and in many instances present grotesque deformities. In many cases it also affects the adjacent muscles and tendons, as well as other connective tissues of the body. The primary disease produces symptomatic swelling, pain and stiffness.
Various new and old drugs have been developed for the treatment of arthritis, anywhere from non-steroidal anti-inflammatory drugs to cortisone. Many of these systemic drugs have dangerous side effects. Their dosage must be carefully prescribed and administered under controlled conditions and circumstances to avoid unpleasant and dangerous side effects.
Several topical agents (creams, ointments, liniments, lotions and the like) have been utilized for the relief of the pains and aches of arthritis. Most of these have provided a little, but only temporary, relief to persons suffering from pain. Many combinations of varying ointments, creams, aqueous solutions, liniments and the like for the treatment of arthritis are known. The most efficacious of these contains as its active ingredient the vegetable products derived from the seed and pods of the capsicum plant, commonly known as red pepper. Capsicum-derived ointment is devised for external application to the affected area of the body by applying to the area adjacent to the muscle, joint or tendon and rubbing it into the skin. The active ingredient is capsaicin. With initial as well as persistent application, capsaicin is effective to relieve the aches and pains of various muscle or skeletal origin, such as arthritis, muscle strains, tendonitis, bursitis and soft tissue diseases.
Capsacin is also effective to relieve the various musculoskeletal pains, itching, neuropathic pains, dysesthesias caused by shingles, post herpetic neuralgia, post mastectomy pain, and peripheral neuropathies. It is further commonly prescribed to reduce the pain of neuropathies produced by diabetes (burning pain, discomfort, often at night) and other diseases that are neuropathic in origin including the discomfort and odd sensations of shingles (post herpetic neuralgia, which can be extremely painful), as well as dysesthesias that can occur with thoracotomies and post surgical scars.
Unfortunately, although capsaicin is often the most effective agent available, the active ingredient is a potent skin irritant, producing a burning, uncomfortable sensation to the skin. Although prescribed frequently, it is used to only a limited extent due to this unpleasant side effect.
The burning side effect has also discouraged the use of capsaicin to treat other types of discomfort, such as pruritus or itching. Pruritus or itching can be caused by many stimuli, such as poison ivy, hemorrhoids, or athlete's foot. The unpleasant side effects of capsaicin have discouraged its use to treat such types of discomfort Also, the burning that occurs when the skin is exposed to sunlight that has been treated with capsaicin or exposed to water has discouraged the use of capsaicin.
A capsaicin based pain reliever which does not irritate the skin or cause a burning discomfort even when exposed to water and sunlight, would be extremely desirable and acceptable to patients and people in general who are experiencing the types of pain or discomfort outlined above.
Prior attempts to produce such an invention can be seen in U.S. Pat. No. 5,134,166 and U.S. Pat. No. 4,997,853, which use anesthetics in association with capsaicin, effectively numbing sites. The present invention does not attempt to numb the site, but instead permits continued use of the hand or foot, with sensory input remaining in tact, rather than simply blocking all sensory input to the area while warming with capsaicin.
OBJECTS OF THE INVENTION
It is an object of this invention to provide a capsaicin based pain reliever, which can be applied transdermally.
It is another object of this invention to provide a method for formulating a no-burn capsaicin-based pain reliever for tendons, muscles and joints in which the capsaicin is fully functional, one, which provides analgesic and anesthetic properties.
Another object of the invention is to provide a topical formulation, which can be used for blows and strains to muscles.
SUMMARY OF THE INVENTION
In accordance with one aspect of the invention, there is provided a composition comprising a carrier, capsaicin, an encapsulation agent, an ester of amino acid and a light-diffusing compound.
In accordance with another aspect of the invention, there is provided a method for treating a victim of pain or discomfort. The treatment comprises applying the above-described composition topically to the skin of the victim near an area affected by the pain or discomfort.
In accordance with a further aspect of the invention, there is provided a method for making a composition useful for topical application to treat pain or discomfort. The method is carried out by mixing a carrier to form an aqueous solution, adding an encapsulation agent to reduce burning of the capsaicin, adding an amount of esters of amino acids and finally adding a light refractive element having an ability to stop secondary burning effect by the capsaicin due to the suns rays. The resulting aqueous solution preferably has a cream-like viscosity.


REFERENCES:
patent: 4546112 (1985-10-01), LaHann et al.
patent: 4963591 (1990-10-01), Fourman et al.
patent: 5856361 (1999-01-01), Holt et al.
patent: 6074652 (2000-06-01), Ishiwatari et al.
patent: 6197823 (2001-03-01), Barr et al.
patent: 6221915 (2001-04-01), McCleane
patent: 6248763 (2001-06-01), Scivoletto
patent: 6348501 (2002-02-01), Holt et al.

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