Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2001-09-24
2002-08-06
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S588000, C514S859000
Reexamination Certificate
active
06429231
ABSTRACT:
FIELD OF THE INVENTION
This present disclosure relates to novel compositions containing antimicrobial agents and urea as components for the treatment of dermatological disorders.
BACKGROUND OF THE INVENTION
There is a need to provide antimicrobial agent compositions, which are easily and economically prepared, which have a smooth texture appropriate for cosmetic products, and which are enhanced by exhibiting greater keratolytic and antimicrobial effects. Compositions containing antimicrobial agents and urea as components and particularly compositions containing sulfacetamide and urea, or sulfacetamide, urea, and sulfur as components might satisfy such a need. Yet such compositions are not currently available.
SUMMARY
The present invention relates to a topical composition that combines the benefits of urea and antimicrobial agents. In one embodiment the topical composition comprises an antimicrobial agent, urea, and a dermatologically acceptable carrier. In another embodiment, the topical composition comprises sulfacetamide or a salt thereof, urea, and a dermatologically acceptable carrier. In yet another embodiment, the topical composition comprises sulfacetamide or a salt thereof, urea, sulfur, and a dermatologically acceptable carrier.
The topical composition of the invention can be useful in treating dermatological disorders. Examples of dermatological disorders that can be treated by the composition include disorders due to microbial infection or changes in normal keratinization, epidermal formation or pilosebaceous function, such as acne, psoriasis, seborrhea, rosacea, ingrown hairs and pseudofolliculitis barbae, and hyperpigmented skin, and cutaneous infection.
In one embodiment, the invention provides a method for treating a dermatological disorder comprising administering to a subject in need thereof a topical composition of the invention. In another embodiment, the invention provides a method for treating acne.
DETAILED DESCRIPTION OF THE INVENTION
Antimicrobial agents and urea are pharmacological agents useful for the treatment of dermatological disorders. However, compositions comprising dermatologically effective amounts of a combination of antimicrobial agents and urea are not currently available. Additionally, compositions comprising dermatologically effective amounts of a combination of sulfacetamide or a salt thereof and urea, and sulfacetamide or a salt thereof and urea optionally with sulfur are not currently available. The current disclosure describes such novel compositions.
Topical Composition
The invention provides topical compositions comprising antimicrobial agents and urea. In one embodiment, the invention provides topical compositions comprising sulfacetamide or a salt thereof and urea. In another embodiment, the invention provides topical compositions comprising sulfacetamide or a salt thereof, urea, and sulfur. The desired amount of active ingredient can vary from composition to composition depending on the particular disorder or disorders being treated, the severity of the disorder, the duration of the treatment, the other specific components of the composition being used, and like factors.
In one embodiment, the antimicrobial agent can be present in the composition at a concentration from about 0.001% to about 20% by weight. In another embodiment, the antimicrobial agent can. be present at a concentration of about 10% by weight.
In one embodiment, the urea can be present in the composition at a concentration from about 0.1% to about 40% by weight, relative to the weight of the composition. In another embodiment, the urea can be present in the composition at a concentration from about 10 to about 40% by weight. In yet another embodiment, the urea can be present in the composition from about 10% to about 20% by weight.
One or more antimicrobial agent agents can be included in the compositions of the invention. As used herein, “antimicrobial agent” or “antimicrobial agent” means an agent that can inhibit the growth of a microorganism or kill a microorganism. Antimicrobial agent agents can have microbial-static effects and/or microbial-cidal effects. Antimicrobial agents can be synthetic compounds, semisynthetic compounds, and naturally produced compounds. As used herein, “antimicrobial agent” refers to both an antimicrobial agent compound and salts thereof. Preferably the antimicrobial agents are dermatologically absorbable. Suitable dermatologically absorbable antimicrobial agents include erythromycin, bacitracin, zinc bacitracin, polymycin, neomycin, chloramphenicol, tetracycline, sulfacetamide, minocycline, clindamycin, doxycycline, undecylenic acid and salts thereof, propionic acid and salts thereof, caprylic acid and salts thereof, ciprofloxacin, cephlasporins, benzoic. acid, ciclopiroxolamine, clotrimazole, econazole nitrate, metronizadole, miconazole nitrate, ketacanazole, oxiconazole, tolnaftate.
In one embodiment, the composition comprises sulfacetamide or a salt thereof and urea. The sulfacetamide salt can be, for example, sodium sulfacetamide. In one embodiment, the composition comprises sulfacetamide or a salt thereof at a concentration in the range of about 5% to 20% by weight, relative to the weight of the composition. In another embodiment, the composition comprises sulfacetamide or a salt thereof at about 10% by weight. In yet another embodiment, the composition comprises urea in the range of about 1% to about 40% by weight, relative to the weight of the composition. In still another embodiment, the composition comprises about 10% to about 40% urea by weight. In another embodiment, the composition comprises urea in a concentration in the range of about 10 to about 20% by weight. In addition to sulfacetamide or a salt thereof and urea, the composition can further comprise sulfur. In one embodiment, the sulfur can be present in the composition at a concentration from about 1% to about 10% by weight, relative to the weight of the composition. In another embodiment, the sulfur can be present at a concentration of about 5% by weight, relative to the weight of the composition.
Any dermatologically acceptable carrier can be used in the compositions of the invention. As used herein, “dermatologically acceptable carrier” refers to vehicles, diluents, carries, which can include adjuvants, additives, or excipients, known for use in dermatological compositions. The compositions of the invention include, but are not limited to, creams, ointments, solutions, lacquers, sticks, pledgets, wipes, cleansers and/or gels.
In one embodiment, the composition is a solution that can be used as a cleanser. In another embodiment, the composition can be used as a lotion.
In yet another embodiment, the topical composition is a semi-solid at room temperature but is easily absorbed into the stratum corneum. The semi-solid composition can be a cream. Such a composition can include petroleum-based liquids and solid fractions as skin protectants. The solid skin protectant can be semi-solid. The solid skin protectant can be present in about 5.5% to about 20% in the composition and includes petrolatum or a synthetic or semi-synthetic hydrocarbon of the same nature as petrolatum. Mixtures of such ingredients can also be used. Liquid skin protectants can be petrolatum and contained in the composition in about 10% to about 20% and include any synthetic or semi-synthetic oleaginous liquid fraction. The liquid skin protectant can be mineral oil, which is a liquid mixture of hydrocarbons obtained from petroleum.
The compositions of the invention can include propylene glycol. Propylene glycol can be present in the composition up to about 10%. In one embodiment, propylene glycol is present in the composition at about 1% to about 5%.
The compositions can contain conventional preservatives, such as methyl paraben, propyl and butyl imidazolidinylurea, diazolidinylurea, methylchloroiso-thiazolinone and methylisothiazolinone. Although not to be held by theory, it is believed that the antimicrobial properties of the urea and antimicrobial agents and propylene glycol allow the compos
Bhagwat Dileep
Glassman Bradley P.
Glassman Daniel
Bradley Pharmaceuticals, Inc.
Jarvis William R. A.
Kim Vickie
Merchant & Gould P.C.
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