Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1997-03-31
1998-06-16
Spivack, Phyllis G.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514714, 514859, A61K 3171, A61K 31075
Patent
active
057670986
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to a method and pharmaceutical composition useful for the topical treatment of acne.
Acne is a common inflammatory disease which is very common at puberty and which occurs in skin areas where sebaceous glands are largest, most numerous, and most active. In its milder forms, acne is a superficial disorder which is evidenced by slight, spotty irritations, and which can be treated satisfactorily by ordinary skin hygiene. However, pilosebaceous follicles occurs and results in the formation of pustules, infected cysts and, in extreme cases, canalizing inflamed and infected sacs, which may become extensive and leave permanent, disfiguring scars.
Therapeutic methods for treating acne include the systemic and topical administration of anti-acne agents such as antibiotics or derivatives of Vitamin A acid. In all but the severest of cases, systemic treatment of acne is not desirable because of side effects. However, systemic methods have been extensively used to treat acne because there has not been available a topical formulation which possess the level of therapeutic effectiveness desirable to relieve the unsightly symptoms of the acne disease condition.
One aspect of the present invention relates to an improved topical anti-acne composition.
REPORTED DEVELOPMENTS
Topical anti-acne preparations include, for example, sulfur, resorcinol, salicylic acid, benzoyl peroxide, and/or antibiotics. Exemplary antibiotics incorporated in compositions are disclosed in U.S. Pat. No. 3,969,516 (lincomycin family); BR Publication No. 1,594,314 (erythromycin); and U.S. Pat. No. 3,952,099 (tetracycline). Compositions containing a peroxide are reported in U.S. Pat. Nos. 3,535,422; 4,056,611; 4,387,107, and British Publication No. 1,594,314 and U.S. Pat. No. 4,497,794. Antibiotic-containing compositions which also include anti-inflammatory steroids are disclosed in U.S. Pat. No. 4,132,781.
Attempts to improve the effectiveness of topical antibiotic compositions for use in the treatment of acne have taken a number of approaches. One approach is reported in U.S. Pat. Nos. 3,989,815; 3,989,816; 3,991,203; 4,122,170; 4,316,893; 4,444,762; and EP 27,286, which disclose skin-penetrating vehicle compositions that reportedly increase the transdermal absorption of any physiologically active substance, including antibiotics. However, not all penetrating agents in combination with antibiotics are effective for the treatment of acne. For example, the aforesaid '781 patent discloses that the use of a skin-penetrating vehicle results in an effective anti-acne composition with erythromycin, but not with tetracycline.
A further approach relates to the use of a composition which utilized two different active agents, such as erythromycin, Vitamin A acid or benzoyl peroxide. Compositions including mixtures of a peroxide and erythromycin are reported in British Publication No. 1,594,314 and U.S. Pat. No. 4,497,794.
The reported topical anti-acne methods and compositions exhibit the disadvantages of limited effectiveness and frequent excessive adverse skin reactions.
SUMMARY OF THE INVENTION
This invention relates to a method for the treatment of acne comprising the topical administration, to a patient afflicted therewith, of a topically effective amount of a peroxide and an antibiotic from the lincomycin or tetracycline families.
As noted above, the prior art discloses compositions which include separately benzoyl peroxide or an antibiotic of the lincomycin or tetracycline family. Another aspect of the present invention relates to a composition which is effective in the treatment of acne, and which includes, as essential ingredients, a peroxide and an antibiotic from the lincomycin or tetracycline families or a pharmaceutically acceptable salt or ester thereof.
Another aspect of this invention is the provision of a stable anti-acne composition by adjusting the pH of the composition to an effective stabilizing pH and/or by incorporating an effective stabilizing amount of docusate salts, such as dioctyl
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Klein Robert W.
Packman Albert M.
Dermik Laboratories Inc.
Oehler Ross J.
Spivack Phyllis G.
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