Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2001-06-04
2003-12-16
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S858000, C514S724000
Reexamination Certificate
active
06664292
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods for treating pathological conditions of the nail and compositions useful therefor. In a particular aspect, the invention relates to methods for treating conditions resulting from bacterial or fungal infections of the nail, and compositions useful therefor.
BACKGROUND OF THE INVENTION
In the field of dermatology, topical administration of pharmaceutically active agents has often been employed for treating pathological conditions. Many of the concerns associated with other types of administration can often be avoided by topically administering an active agent to a subject in need thereof. For example, reliable delivery of a pharmaceutically active agent to organs or tissues in need thereof via oral administration is often difficult due to variable rates of absorption and metabolism associated with oral delivery. In contrast, topical administration of a pharmaceutically active agent can provide high doses of the active agent directly to the infected area, and often minimizes side effects.
Although maladies of the skin can often be effectively treated by topical administration of pharmaceutically active agents, successful treatment of conditions of the nail has remained elusive. Due to the hyperkeratotic nature of the nail, pharmaceutical formulations in the form of creams, gels, and lotions are unable to penetrate the nail plate. Thus, it has proven quite difficult to effectively deliver a pharmaceutically active agent into and beneath the nail plate, where the cause of the pathological condition originates.
A particular condition of the nail which remains ineffectively treated is onychomycosis. This condition is a fungal infection of the nail most frequently caused by dermatophytes and molds. Indeed, onychomycosis refers to any dermatophyte infection of the nail plate and includes infection of nails by any fungus, such as yeast, molds, and the like. Onychomycosis results in a discoloration of the finger nails and toe nails which is often accompanied by pain when pressure is applied to the infected nail.
A number of attempts have been made to effectively treat nail fungus, each meeting with limited success. For example, surgical removal of the nail or drilling holes in the nail to allow penetration of anti-fungal topical treatments results in considerable patient discomfort; systemic administration of anti-fungal drugs suffers from the inherent difficulties involved with parenteral administration and may also result in undesirable side-effects; and anti-fungal lacquers (painted on the nail) lack the necessary penetrating power to directly reach the fungal infection.
Accordingly, there remains a need for effective treatment of pathological conditions of the nail.
BRIEF DESCRIPTION OF THE INVENTION
In accordance with the present invention, there are provided methods for treatment of pathological conditions of the nail. Invention methods comprise topically applying to the affected area an effective amount of a composition comprising an optionally substituted lower alcohol and an optionally substituted lower carboxylic acid. Invention methods effectively treat bacterial or fungal infections of the nail by utilizing a low viscosity composition having the ability to penetrate through and underneath the nail plate, thereby attacking the infection at its source.
Further provided by the present invention are compositions consisting essentially of an optionally substituted lower alcohol and an optionally substituted lower carboxylic acid. Invention compositions kill on contact all types of microbes, including fungi and bacteria. Thus, these compositions are extremely effective in combating pathological conditions of the nail, such as, for example, onychomycosis.
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Foley & Reiter
Kim Vickie
Reiter Stephen E.
Weddington Kevin E.
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