Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-08-17
2002-05-21
Pryor, Alton (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S273000, C514S345000, C514S359000, C514S396000, C514S397000, C514S497000, C514S570000, C514S723000
Reexamination Certificate
active
06391879
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to therapeutic preparations using dimethyl sulfoxide (DMSO) and polyglycol as a transport mechanism to deliver active agents to infected areas. In particular, the present invention relates to therapeutic preparations using DMSO and polyglycol to deliver anti-fungal agents to infected areas that are relatively inaccessible to conventional therapeutic compounds in order to prevent and/or delay future infections.
BACKGROUND OF THE INVENTION
Infections on the exterior of the human body are caused by a variety of micro-organisms, including bacteria, fungi, and molds. Many micro-organisms living on or within the body are beneficial, but others multiply rapidly and may form infections if left untreated. Some organisms such as microscopic plants or fungi can live on the skin and obtain nourishment from dead tissues such as hair, nails, and outer skin layers. When fungi growing on the body grows out of control, an infection can result with detrimental effects to living tissue. In addition, fungal infections are communicable and individuals who frequent swimming pools, gyms, shower rooms, and other humid and/or wet environments are susceptible to being infected with various types of fungal infections as other infected individuals visit these public areas.
One class of external fungi is Onychomrycosis, commonly referred to as nail fungus, Onychomycosis is an infection of the nail (i.e. unguis) and nail bed caused by pathogenic fungi, among other microorganisms, and while not life threatening the disease can cause chronic discomfort and embarrassment. The disease attacks the nails and their growth centers making them appear cracked, yellow, and highly disfigured. In acute cases, Onychomycosis can cause the nail to become thick and yellow in color, making it vulnerable to easy damage and from which subungual hemorrhages can result.
Onychomrycosis is caused by a variety of micro-organisms such as dermatophytes, yeast, and molds. However, the majority of Onychomycosis cases are caused by fungi such as Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, and Epidermophyton floccosum. Once these microorganisms establish subcutaneous growth, eradication with current over the counter treatment is difficult and recurrences of the disease can be costly and time consuming.
In recent years Onychomycosis has spread to a higher percentage of adults due in part, to its contagious nature and the lack of effective medications that can quickly cure the disease once established within the nail bed. Current treatments include long term (
3
-
9
months) application of topical fungicidal creams and/or solutions in combination with systemic fungal treatment drugs such as griseoflilvin, terbinafine, and itraconazole. Some of the systemic treatments have undesirable side effects such as nausea, headache, photosensitivity, gastrointestinal intolerance, elevated liver enzymes, and undesirable drug interactions, making the process of eradication difficult and troublesome.
It is also noted that systemic fungal treatments are expensive. A treatment program using terbinafine tablets (250 mg) can cost over $600.00 and a therapy using itraconazole can cost between $600.00 and $1,200.00. Conversely, the instant invention contemplates a non-systemic treatment program costing under $50.00.
Part of the difficulty of quickly curing Onychomycosis is the inability to deliver effective anti-fungal agents to the pathogenically active areas such that all of the pathogenic fungus is eradicated. Without full eradication, reoccurrence is likely necessitating a new cycle of combined topical and/or systemic treatments, with the aforementioned systemic effects. Treatment is complicated by the fact that the cutaneous nail shell is not easily penetrated and treatments of infected areas often require thinning of the nail to allow better penetration of anti-fungal agents. The nail acts as a protective barrier under which fungus can grow unhindered and even acts as a vessel for spreading the disease. Current topical anti-fungal ointments and solutions used to treat Onychomycosis do not penetrate in to nail bed easily and tend to leave some portion of the fungus alive after treatment causing reoccurrence of the disease. Heretofore, the medical industry has not produced a topical treatment having the necessary chemical properties to effectively pass through the hard cutaneous nail shell and penetrate into the nail bed for rapid and complete destruction of the fungal infection.
A second class of external fungi is tinea pedis commonly referred to as “athlete's foot.” Tinea pedis is the most common infection of all fungal infections. It is also the most persistent. Like onychomycosis, Tinea pedis is caused by dermatophytes such as Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton tonsurans, and Epidermphyton floccosum. These types of fungi live on the dead tissue of the nails, hair, and outer skin layers. Also like onychomycosis, Tinea Pedis is very contagious, Tinea Pedis thrives in warm, moist areas. Public areas like bathrooms, gyms, and pools are ideals place where tinea pedis can be contacted.
Tinea pedis can be treated with the application of topical anti-fungal medications and with self-care. Tinea pedis can be prevented when certain anti-fungal medications are applied to the areas susceptible to tinea infections. By using anti-fungal medications on a daily basis in a vehicle that can deliver the medication to the site of contact, the majority of tinea pedis cases can be prevented.
Therefore, there is a need for a topical solution that quickly and thoroughly penetrates the nail shell, underlying nail bed, and surrounding nail tissue to deliver an effective anti-fungal agent that will kill the causes of Onychomycosis and Tinea pedis.
SUMMARY OF THE INVENTION
It is the object of the present invention to provide a topical solution containing effective anti-fungal agents that will penetrate the hard cutaneous shell to kill the cause of Onychomycosis.
A further object of the present invention is to provide a method of making the penetrating topical solution.
An even further object of the present invention is to provide for a therapeutic treatment procedure for curing Onychomycosis without the advent of systemic drugs.
In summary, the invention provides for a combination of an anti-fungal agent with the combination of DMSO and an anhydrous solution of polyglycol. The combination of DMSO and polyglycol act as a delivery vehicle so that active anti-fungal agents such as Tolnaftate can be delivered directly to fungal infected areas under and around the nail. The Tolnaftate and DMSO are dissolved in a viscous solution of polyglycol so that the combined ingredients may be applied directly to the affected nails in a topical solution. The therapeutic solution is created by dissolving the Tolnaftate into a portion of the DMSO until dissolution takes place. Then combining the two liquids and adding the balance of the polyglycol until the desired volume is reached. Repeated applications of the resulting solution on Onychomycosis infected nails over a period of 12-16 weeks yields an 85% to 90% satisfactory result rate without augmenting the topical treatments with systemic drugs. Most versions of the preferred solution may be sold over-the-counter and should cost far less than current methods of Onychomycosis eradication.
Another object of the invention is to provide a topical solution containing effective anti-fungal agents that will prevent future episodes of tinea pedis and onychomycosis when used on a daily basis. Daily applications of the resulting solution to areas of skin, nails, and scalp that are susceptible to tinea infections can help prevent and/or delay any future episodes of tinea infections.
Other features and objects and advantages of the present invention will become apparent from a reading of the following description.
REFERENCES:
patent: 4073922 (1978-02-01), Wyburn-Mason
patent: 4608249 (1986-08-01), Otsuka et al.
patent: 4652557 (1
Astan, Inc.
Bush Kenneth M.
Gache' Russell C.
Pryor Alton
Sirote & Permutt P.C.
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