Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2000-08-03
2001-10-09
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C424S401000, C424S725000
Reexamination Certificate
active
06300326
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to compositions for treating cutaneous inflammation by topical application of a corticosteroid containing formulation and, more particularly, to a sprayable composition amenable to treat cutaneous inflammation syndromes such as chronic, non-responsive allergic dermatitis, and a method to treat the dermal areas of mammals with such composition. The composition has the surprising and unexpected benefit of incorporating lower concentrations of active ingredient, allowing longer term use as well as use over larger skin surface areas of afflicted patients with reduced risks to the patients.
BACKGROUND OF THE INVENTION
Many individuals are affected by eczema or inflammation of the skin. A topic dermatitis is the most severe and chronic form of eczema, although there are several other skin conditions that are eczemas including seborrheic dermatitis, irritant contact dermatitis, and allergic contact dermatitis. Skin inflammations may be triggered by any number of factors. For example, irritant contact (such as by solvents, chemicals, detergents, etc.) may trigger eczema. Eczema may also be triggered by allergens, for example by dermal exposure to plant species such as poison ivy, poison oak and poison sumac. Individuals with severe eczema such as a topic dermatitis are often prone to secondary skin infections such as by Staphylococcus bacteria or Herpes virus.
It is known in the art to treat inflammatory and pruritic manifestations of dermatitis syndromes topically with corticosteroids. The mechanism of anti-inflammatory actions of topical corticosteroids has not been completely elucidated. However, it is thought that corticosteroids act by inducing phospholipase A
2
inhibitory proteins called lipocortins. Lipocortins may control synthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Heretofore, corticosteroid treatments for dermatitis have been topical applications in the form of creams gels, or lotions. These medicamentous vehicles tend to leave a greasy layer on the treated area which can be unpleasant to the recipient. Additionally, the task of preparing the appropriate suspension of active ingredients in a cream, lotion, or gel form can be laborious. Thus, the prior compositions of active medicaments, dispersed in their related delivery media, do not provide an ideal solution for treating dermal inflammation and irritation.
More importantly, corticosteroid treatments for dermatitis have traditionally incorporated higher concentrations of steroid, typically 0.1 percent by weight or higher, to provide beneficial effects. For example, U.S. Pat. No. 4,343,798 teaches use of corticosteroids in combination with C
5
-C
12
fatty acids for topical treatment of inflammatory skin conditions. Typical concentrations of corticosteroid taught in the '798 patent include 0.5 percent by weight beclomethasone dipropionate, 0.1 percent by weight hydrocortisone butyrate, 1 percent by weight hydrocortisone with urea, and 0.1 percent by weight triamcinolone acetonide. Similarly, U.S. Pat. No. 4,107,161 teaches use of a triamcinolone isomer at concentrations ranging from 0.1 percent to 0.5 percent by weight.
There are significant disadvantages to prior compositions which utilize corticosteroids in higher concentrations. Systemic absorption of topical corticosteroids may produce a reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may also occur in some patients by systemic absorption of topical corticosteroids during treatment. Pediatric patients, patients receiving treatment with superpotent corticosteroids, patients applying topical steroids over a large skin surface area, and patients applying corticosteroids to areas under occlusion are at particular risk. Due to potentially harmful side effects, current formulations employing corticosteroids for topical treatment of skin inflammation are often limited in terms of the size of the skin area which may be treated and the length of time over which treatment may occur.
Often, however, eczemas (such as allergic contact dermatitis) which are of uncertain origin and chronic in nature manifest in patients, necessitating longer-term treatments and treatments over large skin areas. There is thus need in the art for a corticosteroid treatment for chronic dermatitis which incorporates lower concentrations of corticosteroid and is therefore suitable for longer periods of treatment. There is also need for such a corticosteroid treatment which may be conveniently applied over large skin surface areas without the disadvantages associated with cream or lotion carriers. One such means for avoiding cream or lotion formulations is a dip treatment. However, dipping is unsuitable for larger patients such as humans or large animals due to difficulties in application and the large quantities of medicament required. In response to the need in the art, the applicant has developed a new and improved spray formulation that successfully treats skin conditions such as chronic, non-responsive allergic dermatitis which incorporates reduced concentrations of corticosteroid.
SUMMARY OF THE INVENTION
It is therefore a primary object of the present invention to provide a composition that is effective in treating the inflammation and irritation associated with skin disorders such as dermatitis with pruritic activity.
A further object of the present invention is to provide a composition that is effective in treating inflammation and irritation associated with skin disorders such as dermatitis which incorporates a lower concentration of active ingredient, allowing longer-term treatment with reduced risk to the patient.
Another object of the present invention is to provide a composition that is of an appropriate liquid character to facilitate application in spray form.
Yet another object of the present invention is to provide a composition that is sprayable for topical application and in which the liquid carrier evaporates and leaves the active medicaments in the treated area as a dry film.
Still another object of the present invention is to provide a method of treating dermal areas of mammals that is both pleasant and easy in application and effective in result.
Additional objects, advantages and other novel features of the invention will be set forth in part in the description that follows and in part will become apparent to those skilled in the art upon examination of the following or may be learned with the practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
To achieve the foregoing and other objects, and in accordance with the purposes of the present invention as described herein, an inventive composition is disclosed having ingredients which, in combination, result in an effective formulation for topically treating the inflammation and irritation associated with such skin conditions as allergic contact dermatitis. The composition preferably contains a range of from about 5.0 percent to about 80.0 percent by volume anti-infective solvent, and from about 10.0 percent to about 90.0 percent by volume water. Denatured lower alcohols such as isopropyl alcohol and ethyl alcohol are desirably used as the solvents. These components when mixed together provide a medium for active medicaments resulting in a sprayable liquid that is used for topical application.
In the particular preferred formulation, the composition includes from about 50 percent to about 80 percent by volume water. Furthermore, the anti-infective solvent ranges from about 5 percent to about 30 percent by volume.
The inventive composition is also contemplated to include from about 5.0 percent to about 40.0 percent by volume emollient agent. It has been determined that the most desired volumetric composition r
Dobbs Michael R.
McArthur T. Reid
Henley III Raymond
King and Schickli PLLC
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