Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2002-03-08
2003-02-11
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S404000, C424S078020, C424S078030, C424S078060, C514S772000, C514S859000, C514S563000, C514S886000, C514S871000, C514S887000
Reexamination Certificate
active
06517847
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to a composition for treating a skin disorder in a human, and a method of administering and preparing such composition.
2. Background
Skin disorders are a common problem in childhood, adolescence and adulthood. Skin disorders can include, for example, acne, inflammatory diseases such as atopic eczema, or rosacea.
Acne vulgaris is a follicular disease characterized by pilosebaceous inflammations such as comedones, papules, pustules, cysts and nodules. Chiefly a disease of adolescence (and often a cause of emotional distress), acne originates endogenously and stems for multifactorial influences. Major progressive factors in the development acne include hyperkeratosis of the follicular epithelium, increased sebum production, and proliferation of
Propionibacterium acnes
. These factors are primarily responsible for hyperkeratosis of the follicle lining, including retention of keratin and sebum, as well as the free fatty acid by-products of
P.acnes
metabolization which can lead to inflamed acne papules and pustules.
Although acne may also be influenced by exogeneous and hormonal factors., research has been centered around eliminating
P.acnes
, the most common cause of inflammation. To date the pathogenesis of acne is not fully understood, and there is currently no cure for the disease. Many systemic and topical medications, such as tetracycline, have been used to manage and control acne. None, however, is universally successful.
Acne treatment is typified by “polypharmacy”, whereby physicians employee simultaneous treatment with a variety of modalities. The search for improved acne treatments has been widespread and continuous during the past several decades. Enhanced cosmetic properties to encourage user compliance, the use of topical therapies in place of systemic drugs to reduce toxicity and side effects, and the introduction of new drugs and formulations represent the forefront of acne treatment advances.
The first use of a topical antibiotic, erythromycin, for the treatment of acne was reported by Fulton (Fulton, J. E. Jr. and Pablo, G.
Topical antibacterial therapy for acne
. Study of the family of erythomycins. Arch. Dermatol. 110:83-86, 1974). Topical administration of these potent agents has the advantage of reduced side effects, particularly those caused by systemic drug effects, e.g., nausea, gastrointestinal upset, diarrhea, and vaginal yeast overgrowth.
Lincomycin antibiotics have been employed in the topical treatment of acne (U.S. Pat. No. 3,969,516). Lincomycin was commercialized by Upjohn Co. (now Pharmacia & Upjohn) as Cleocin T Solution, Gel, Lotion and Pledgets. Cleocin T Gel was an improvement over Cleocin T Solution because of the elimination of alcohol and the ease of application to the facial skin for the treatment of acne. This gel is based on carbomer 934, NF.
Atopic dermatitis is a polygenic disease with an inherited predelection and strongly influenced by environmental factors. The condition affects infants, children, adolescents and adults and is allergic in nature. The distribution is symmetrical, typically involving the face, neck and flexural areas. Atopic dermatitis is chronic, relapsing and usually pruritic. Topical treatment frequently includes topical corticosteroids, such as desonide, hydrocortisone valerate, fluocinolone acetonide, triamcinolone acetonide, betamethasone valerate, hydrocortisone butyrate, halobetasol propionate, betamethasone dipropionate, clobetasol propionate, difloransone diacetate, fluticasone propionate, budesonide or the like.
Rosacca is a chronic inflammatory eruption of the nose, face and other flushing areas of the skin. The disease is most common in middle aged women and is characterized by erythema, papules, pustules, telangiectasia and enlarged sebaceous glands. The cause etiology is not totally clear; however vasomotor lability and menopause are predisposing factors. The organism Demodex folliculorum is found frequently in the contents of inflamed pustular follicles, and has a possible role in this skin disorder. Treatments include topical metronidazole and oral tetracycline type antibiotics.
SUMMARY OF THE INVENTION
One aspect of this invention is a composition having a pH of about 3.0 to about 9.0 and a viscosity of less than about 15,000 centipoise (cP) for treating a skin disorder in a human subject. The composition comprises (a) a therapeutically-effective amount of at least one compound useful for treating such disorder, (b) a pharnaceutically-acceptable polyacrylic acid polymer compatible with the compound, (c) optionally a water miscible solvent, (d) optionally a preservative, (e) optionally an oil phase and surfactant, and (f) water.
Another aspect of the invention is a composition described above in combination with a container that accurately administers a portion of the composition for topical administration to a patient.
Another aspect of the invention is a composition described above in combination with labeling instructions for use in treating the skin disorder.
Still another aspect of the invention is a method for treating a skin disorder in a human subject, which method comprises administering a composition described above to an affected area of the subject's skin having such disorder in an amount and for a period of time sufficient to improve the skin disorder.
Still another aspect of the invention is a method for preparing a composition of this invention by combining water with a therapeutically-effective amount of a suitable compound and the polymer and optionally a water-miscible solvent and preservative. If a lotion is desired an oil phase is formed for integration with the aqueous phase.
Other aspects of the invention may be apparent upon further reading the specification and claims of the patent application.
SPECIFIC DESCRIPTION
This invention provides a novel topical gel or lotion delivery system for the treatment of skin diseases, particularly acne vulgaris. One unique aspect of the system is the use of a polymeric material that provides a gel material that has a very low viscosity but which is cosmetically elegant and aids in the administration process by providing a pourable composition that flows through a dropper tip easily.
The Composition
One aspect of this invention is a composition having a pH of about 3 to about 9 and a viscosity of less than about 15,000 cP for treating a skin disorder in a human subject. The composition comprises a therapeutically-effective amount of at least one compound useful for treating such disorder, a pharmaceutically-acceptable, lightly cross-linked polyacrylic acid polymer compatible with the therapeutically-effective compound, optionally a water miscible solvent, optionally a preservative, and water. The composition may include a solution of the active compound or a suspension. A lotion will also include a pharmaceutically-acceptable oil phase emulsified with one or more surfactants.
The composition is useful to treat skin disorders, e.g. acne, rosacea, or inflammatory skin diseases such as atopic dermatitis. The composition will include an active agent that will be one compound alone or two or more compounds in combination. The active agent can be an antibiotic, a corticosteroid, a retinoid, an anti-inflammatory imidazole, a non-steroidal anti-inflammatory agent (NSAID), or a combination.
An antibiotic is generally viewed as a drug that inhibits the growth of an unwanted microorganism. Representative examples of topical antibiotics include lincomycins, (e.g. clindamycin), erythromycin, minocycline, and tetracycline, and the pharmaceutically-acceptable salts, esters, or prodrugs thereof. Preferred is clindamycin phosphate.
A “retinoid” is a keratolytic drug related to retinoic acid and generally includes chemical entities such as retinol and its esters and closely related naturally-occurring derivatives and structurally-related synthetic analogs. This includes, for example, retinol, retinal, tretinoin (all-trans retinoic acid), isotretinoin, adapalene (6-[3-(1-adama
Dow Debra A.
Dow Gordon J.
Lathrop Robert W.
Bennett Rachel M.
Cooley & Godward LLP
Dow Pharmaceutical Sciences
Moran Tom M.
Page Thurman K.
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