Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
2001-05-02
2004-05-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S401000
Reexamination Certificate
active
06740330
ABSTRACT:
BACKGROUND OF THE INVENTION
Acne vulgaris is an inflammatory disease of the sebaceous glands characterized by an eruption of the skin, often pustular in nature but not suppurative. Acne is a common affliction of the adolescent and affects a small but significant percentage of the adult population. Acne involvement results in unsightly lesions, particularly on the face, and in some cases results in severe scarring.
There are a variety of methods for treating acne vulgaris including administering various agents either orally or topically to the skin. Nevertheless, acne vulgaris is seldom cured and only can be controlled with difficulty.
One of the most common agents utilized to topically treat acne is benzoyl peroxide. Benzoyl peroxide is contained in a variety of over-the-counter and prescription acne products which take the form of lotions, creams or gels. The exact mode of action of benzoyl peroxide is unknown, but the best evidence suggests an antibacterial effect against an organism Propionibacterium acnes.
Tubes and bottles of acne medicines are the most common ways of packing such topical agents. However, tubes and bottles are inconvenient for patients to carry with themselves to school, camp, office, etc. Consequently, over the last decade a new method of delivering anti-acne agents has evolved based on incorporating active anti-acne ingredients into small cloth towelettes called pledgettes. These pledgettes can then be packaged in a sealed pouch that can be conveniently opened at the time of use. Additionally, since only one dose is opened at a time, several patients can “share” a box of such pledgettes without exposure to one another's germs, dirt, etc. Topical antibiotics are another popular prescription treatment for acne. Today, pledgettes containing topical antibiotics such as clindamycin and erythromycin are widely used for both their convenience, as well as their safety and efficacy.
While benzoyl peroxide would also be an ideal agent to incorporate into pledgettes for the treatment of acne, numerous attempts to incorporate benzoyl peroxide into pledgettes have been unsuccessful until the current invention. Since the benzoyl peroxide was not completely soluble in any of the vehicles tried, a considerable amount of the benzoyl peroxide was selectively “trapped” in the pledgette fibers, rendering the delivery of benzoyl peroxide to the skin uncertain. The applicant of this patent application had himself trial to produce benzoyl peroxide pledgettes several times in the 1980's and early 1990's without success for the very reason given above. However, surprisingly, the applicant has recently discovered a way or producing pledgettes such that the benzoyl peroxide is not selectively trapped in the pledgette material. I have found that by solubilizing benzoyl peroxide in vehicles containing moderate to high concentrations of acetone (from about 30% to 100%), pledgettes containing benzoyl peroxide in acetone compositions can be prepared such that the benzoyl peroxide is not selectively trapped in the pledgette. Consequently, the pledgette delivers the concentration of benzoyl peroxide contained in the acetone composition.
DETAILED DESCRIPTION OF THE INVENTION
In the following detailed description of the invention and in the claims, all percentage amounts are stated in terms of weight percent (% w/w).
In accordance with this invention, compositions are provided whereby benzoyl peroxide is incorporated in vehicles containing about 30% to about 100% acetone so that the benzoyl peroxide is solubilized. Cloth pledgettes made of cotton, wool, nylon, rayon or other synthetic fabrics are then impregnated with such compositions and the resulting individual benzoyl peroxide pledgettes preferably are packaged in individual pouches, such as foil or plastic. Individual benzoyl peroxide pouches are then opened, the pledgette removed, and the pledgette rubbed across the surface of the face or other acne bearing area which the patient intends to treat for acne. Following use in this fashion, individual pledgettes are then discarded.
The instant invention thus relates to an article for use in the treatment of acne vulgaris, the article comprising a fiber pledgette impregnated with a composition comprising benzoyl peroxide and an amount of acetone sufficient to solubilize the benzoyl peroxide. Preferably, the pledgettes are packaged in individual pouches. The instant invention also comprises the method of manufacturing an article for use in the treatment of acne vulgaris comprising impregnating fiber pledgettes with a composition comprising benzoyl peroxide and an amount of acetone sufficient to solubilize the benzoyl peroxide, preferably packaging the pledgettes in individual pouches. The pouches can comprise known flexible, impermeable, sealable non-reactive materials such as aluminum foil, plastic film, or combinations of such materials.
The composition used to impregnate the cloth pledgette comprises benzoyl peroxide in the range of about 2-10%, and most preferably about 4.0-10%. Purified water is optionally present in an amount ranging from 0% to about 65%. Other optional ingredients include polyethylene glycol 400, which can be present in the range of about 0-15%, and glycerin which can be present in the range of about 0-20%. The balance of the composition is acetone. In a preferred embodiment the composition will comprise at least about 30% acetone.
The composition is prepared by blending the selected ingredients at ambient temperature until solubilization of the benzoyl peroxide is complete. Pledgettes of a desired fabric are then impregnated with the composition. Preferably, the pledgettes are packaged in individual pouches.
REFERENCES:
patent: 4749080 (1988-06-01), Toohey
patent: 5116670 (1992-05-01), Suzuki et al.
patent: 04275316 (1992-09-01), None
patent: WO009320796 (1993-10-01), None
Howard S.
Jones Day
Page Thurman K.
Sirius Laboratories, Inc.
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