Cosmetic skin care compositions containing alpha interferon

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants

Reexamination Certificate

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C424S078030, C424S059000

Reexamination Certificate

active

06328987

ABSTRACT:

BACKGROUND OF THE INVENTION
Maintaining a youthful appearance is of great importance to many people, particularly in an aging population. Several of the visible signs of aging result from its effects on the skin. The passage of time is reflected in the appearance of wrinkles and fine lines; by a slackening of tissue; a loss of cutaneous elasticity; a leathery or dry appearance; and by the yellowing of the skin which becomes duller and loses its radiance. Skin that has been consistently exposed to sunlight throughout life, particularly the face and hands, may show pigmentation marks, telangiectasia and elastosis. At the histological level, skin damage from photoaging is shown in tangled, thickened, abnormal elastic fibers, decreased collagen and increased glycosaminoglycan content. The aging process also results in thinning and deterioration of the skin. There is a reduction in cells and in blood supply, and a flattening in the junction between the dermis and epidermis.
Treatments designed to prolong or promote youthful appearance include topical applications of cosmetic preparations, lotions and moisturizer, electrical stimulation, collagen injections and cosmetic surgery. However, there is still a serious need for skin care compositions that treat wrinkles and fine lines, and restore the youthful appearance of the skin.
Relevant Literature
The use of alpha interferon in antiviral topical creams is reviewed by Foldvari et al. (1999)
Biotechnol Appl Biochem
30 (Pt 2):129-37. The creams utilize liposome encapsulated, and or fatty acid acylated derivatives in the formulations. For example, palmitoyl derivatives of interferon alpha2b (p-IFNalpha) were prepared by covalent attachment of the fatty acid to lysine residues in the protein through a reaction with N-hydroxysuccinimide palmitate ester (Foldvari et al. (1998)
J Pharm Sci
87(10):1203-8). Descriptions of the liposome compositions may be in found in U.S. Pat. No. 5,853,755, issued Dec. 29, 1998.
SUMMARY OF THE INVENTION
The present invention features novel cosmetic skin care compositions for treating wrinkles and fine lines; firming skin tissue; and reviving the radiance of the skin. The skin care compositions comprise an alpha interferon and a cosmetically acceptable vechile.
This invention also features methods for the treatment of wrinkles and fine lines; firming skin tissue; and reviving the radiance of the skin, comprising topically applying thereto a cosmetic skin care composition containing an alpha interferon at a concentration of from about 0.5 to 500 U/ml.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Topical compositions are provided for the treatment of wrinkles and fine lines; firming skin tissue; and reviving the radiance of the skin. The skin care compositions comprise an alpha interferon at a concentration of from about 0.5 to 500 U/ml, and a cosmetically acceptable vehicle. The alpha interferon in the composition is preferably free of liposomal encapsulation, and is preferably free of covalently bonded fatty acids not present in native forms of the protein. In a preferred embodiment, the interferon is the human alpha 2b subtype.
The compositions of the invention find use in improving the appearance of fine lines and wrinkles. The compositions may also be used in the treatment of irritated skin, e.g. minor rashes and burns. Further examples of minor skin irritations include acne, cold sores, dry skin, sunburn, cuts, insect bites, laser bums such as those resulting from cosmetic surgery, pruritic lesions and other inflammatory and non-inflammatory lesions of the skin.
Alpha Interferon
Human alpha interferons comprise a family of about 30 protein species, encoded by at least 14 different genes and about 16 alleles. Some of these alpha interferon protein species have been shown to have potent biological activities, including antiviral, antigrowth and immunoregulatory activity. Family members of particular interest include the alpha 2 interferons, e.g. IFN-&agr;2a, IFN-&agr;2b, IFN-&agr;2c. Other alpha interferons that may find use in the present invention include &agr;4a; &agr;4b; &agr;8a; &agr;4a; &agr;8c; &agr;8b; &agr;14c; &agr;10a; &agr;16; &agr;1a; &agr;17a; &agr;1b; &agr;17b; &agr;17c; &agr;14a; &agr;17d; &agr;7a; &agr;21a; &agr;7c; &agr;7a; &agr;21b; and &agr;6.
The sequences of all of these interferon species are available on a variety of commercially available databases, including Genbank database, as well as by reference to the art (see, for example, Goeddel et al (1981) Nature 290:20-26; Nagata et al. (1980)
Nature
284:3126-32; Bowden et al (1984)
Gene
27:87-99; and Ohara and Teraoka (1987)
FEBS Letters
211(1):78-82.
Products containing recombinant interferons are commercially available. For example, IFN-&agr;2b is also available from U.S. Biologics; and is also the recombinant human alpha interferon protein species in the commercially available products, INTRON® A (Schering Plough); and ROFERON® A (Hoffman-La Roche).
The alpha interferon is combined with a cosmetically acceptable vehicle at a concentration of at least about 0.5 U/Ml., and not more than about 500 U/Ml., usually at a concentration of from about 1 U/mi. to not more than about 50 U/mi., and preferably at about at a concentration of from about 2.5 U/ml. to not more than about 10 U/Ml., where the units are based on a standard viral resistance assay as known in the art, e.g. bovine MBDK cells with vesicular stomatitis virus. For example, the IFN-&agr;2b recited in the examples is based on an activity of 10
6
units in 3 &mgr;g of recombinant protein.
The alpha interferon in the composition is preferably unencapsulated, ie. is free of liposomal encapsulation. The alpha interferon is preferably free of covalently attached fatty acids, which not present in native forms of the protein.
Optional Skin Benefit Materials and Cosmetic Adjuncts
The compositions of the invention may optionally comprise other skin benefit materials. These include estradiol; progesterone; pregnanalone; coenzyme Q10; methylsolanomethane (MSM); copper peptide (copper extract); plankton extract (phytosome); transforming growth factor beta 1 (TGF-&bgr;1); glycolic acid; kojic acid; ascorbyl palmitate; all-trans-retinol; azaleic acid; salicylic acid; broparoestrol; estrone; adrostenedione; androstanediols; etc. The steroids will generally present at a concentration of less than about 2% of the total by weight of the composition, while the other skin benefit materials may be present at higher levels, for example as much as 10 to 15%.
The compositions may further comprise sunscreens to lower skin's exposure to harmful UV rays. Sunscreens include those materials commonly employed to block ultraviolet light Illustrative compounds are the derivatives of PABA, cinnamate and derivatives of salicylate (other than ferulyl salicylate). For example, octyl methoxycinnamate and 2-hydroxy-4-methoxy benzophenone (also known as oxybenzone) can be used. Octyl methoxycinnamate and 2-hydroxy-4-methoxy benzophenone are commercially available under the trademarks, Parsol MCX and Benzophenone-3, respectively. Dermascreen may also be used. The exact amount of sunscreen employed in the compositions can vary depending upon the degree of protection desired from the sun's UV radiation.
Cosmetically Acceptable Vehicle
The compositions of the invention comprise a cosmetically acceptable vehicle to act as a dilutant, dispersant or carrier for alpha interferon, so as to facilitate its distribution when the composition is applied to the skin. Vehicles other than or in addition to water can include liquid or solid emollients, solvents, humectants, thickeners and powders.
The cosmetically acceptable vehicle will usually form from 5% to 99.9%, preferably from 25% to 80% by weight of the composition, and can, in the absence of other cosmetic adjuncts, form the balance of the composition.
The compositions may be in the form of aqueous, aqueous/alcoholic or oily solutions; dispersions of the lotion or serum type; anhydrous or lipophilic gels; emulsions of liquid or semi-liquid consistency, which ar

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