Silicone gel containing salicylic acid

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ortho-hydroxybenzoic acid or derivative doai

Reexamination Certificate

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Reexamination Certificate

active

06384023

ABSTRACT:

BACKGROUND OF THE INVENTION
Acne is a condition of the human skin characterized by the excess flow of sebum from sebaceous glands. Excess sebum (e.g., skin oil) on the person's skin inhibits the flow of sebum from hair follicles, causing it to thicken and form a solid plug within the follicle known as a comedone. The formation of comedones stimulates hyperkeratinization, resulting in a closing of the follicle opening. The closed follicle usually results in either a papule, a pustule, or a cyst that becomes infected with bacteria such a p-acnes. This infection is known as acne, or in lesser severity, seborrhea.
Salicylic acid is a known keratolytic agent that has the ability to both penetrate and dissolved comedones as well as kill bacteria (e.g., p. acnes). Salicylic acid, however, has very limited solubility in water and, thus, has typically been formulated in oil-in-water pigmented cosmetic formulations. The use of the oil-in-water formulations, however, does not assist in the absorption of oil from the skin but, rather, just adds more oil to the person's skin.
The present invention relates a topical silicone gel or a topical composition containing the gel (e.g., a water-in-silicone cosmetic foundation). The gel comprises salicylic acid for the treatment of acne and seborrhea. The gel also provides the additional benefit of oil absorbing properties. The oil absorbing properties both assist in the treatment of acne and seborrhea by absorbing excess sebum. In addition, the gel produces a desirable smooth matte finish on the skin treatment area.
SUMMARY OF THE INVENTION
In one aspect, the invention features a silicone gel comprising a volatile liquid, a silicone polymer, and salicylic acid. In one embodiment, the silicone polymer is polysilicone-11. In one embodiment, the volatile liquid is a silicone fluid (e.g., cyclomethicone). In one embodiment, the silicone gel further comprises a second liquid (e.g., dimethicone or a solvent of oalicylic acid). In one embodiment, the solvent is a non-alcohol solvent such as ester, e.g., neopentyl glycol dioctanoate/diisostearate, octyl salicylate, and octyl methoxycinnamate). In one embodiment, the silicone gel further comprises a porous silica (e.g., having a pore volume of 0.1 to about 1 ml/g, a particle diameter of between 1-20 microns, and/or an oil absorbence of between 10-500 ml/100 g). In one embodiment, the gel further comprises petrolatum. In one embodiment, the gel further comprises additional dermatologically active agents such as the anti-acne agents (e.g., benzoyl peroxide, resorcinol, sulfur, sodium borate, thymol, a retinoid, zinc sulfide, or zinc oxide), &agr;-, &bgr;-, and poly-hydroxy acids (e.g., lactic, glycolic, malic, tartaric, and citric acids) and/or anti-microbial or anti-inflammatory agents (e.g., alpha-bisabolol).
In one embodiment, the silicone gel comprises by weight: (a) about 1% to about 99% (e.g., about 10% to about 80%) of the volatile liquid (e.g., cyclomethicone); (b) about 1% to about 90% (e.g., about 10% to about 50%) of the silicone polymer (e.g., polysilicone-11); and (c) about 0.001% to about 50% (e.g., about 1% and about 30%) of the salicylic acid. In a further embodiment, the silicone gel further comprises by weight: (d) about 0.001% to about 50% (e.g., about 0.001% to about 30%) of dimethicone; (e) about 0.001% to about 50% (e.g., about 0.001% to about 30%) of neopentyl glycol dioctanoate/diisostearate; (f) about 0.001% to about 50% (e.g., about 0.001% to about 30%) of porous silica; and/or (g) about 0.001% to about 20% (e.g., about 0.001% to about 5%) of alpha-bisabolol.
In another aspect, the present invention features a composition comprising: (a) the above described silicone gel; and (b) a cosmetically acceptable carrier. In one embodiment, the cosmetically acceptable carrier comprises one or more of the members selected from the group consisting of acidifying agents, alkalizing agents, aerosol propellants, antimicrobial agents, antioxidants, buffering agents, chelating agents, coloring additives, dermotologically active agents, dispersing agents, emollients, emulsifying agents, humectants, fragrances, preservatives, sugars, sunscreen agents, surfactants, suspending agents, thickening agents, and vehicles.
In one embodiment, the composition is a water-in-silicone emulsion comprising by weight: (a) about 0.001% to about 90% (e.g., about 1% to about 50%) of the silicone gel; (b) about 0.001% to about 50% (e.g., about 5% to about 50%) of liquid silicone (e.g., cyclomethicone, dimethicone, or mixtures thereof); and (c) water, e.g., q.s. to 100%, by weight, once all the other ingredients have been added. In a further embodiment, the composition further comprises by weight: (d) about 0.001% to about 50% (e.g., about 0.001% to about 20%) of a humectant (e.g., dipropylene glycol); and (e) about 0.001% to about 50% (e.g., about 0.001% to about 20%) of sunscreen (e.g., titanium dioxide).
In another aspect, the present invention features method of treating (e.g., reducing or eliminating) or preventing acne and seborrhea (e.g., on the skin of a human), the method comprising applying to the skin of a subject an effective amount of the above mentioned silicone gel or composition. In one embodiment, the gel or composition is applied to the skin one to three times daily. When used in treating acne, the composition may be applied until the acne has been successfully treated (e.g., eliminated). When used as a prophylactic for acne, the composition may be applied daily until the risk of acne has subsided. The gel and composition may also be used to treat wrinkles, psoriasis, and hyperpigmentation, smooth skin, reduce skin lines, improve skin clarity and tone, and treat dandruff and seborrheic dermatitis (e.g., in a scalp cream, shampoo, or hair conditioner).
Other features and advantages of the present invention will be apparent from the detailed description of the invention and from the claims.
DETAILED DESCRIPTION OF THE INVENTION
It is believed that one skilled in the art can, based upon the description herein, utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Also, all publications, patent applications, patents, and other references mentioned herein are incorporated by reference.
The present invention relates to a novel silicone gel that both delivers salicylic acid while simultaneously possessing oil-absorbing properties. The present invention also features a cosmetic composition containing the gel (e.g., the gel is dispersed throughout the composition). The silicone gel is made, in one embodiment, by dispersing oil swellable silicone polymer (e.g., polysilicone-11) in a volatile liquid (e.g., silicone fluid such as cyclomethicone) or a volatile liquid mixed with other ingredients (e.g., dimethicone). Salicylic acid is then dispersed in the silicone gel, e.g., by either (i) adding salicylic acid powder to the silicone gel and milling the mixture to ensure homogeneous distribution of the salicylic acid in the gel or (ii) dissolving the salicylic acid in a solvent (e.g., an ester such as neopentyl glycol dioctanoate/diisostearate) and then uniformly dispersing the salicylic acid solution in the silicone gel. Salicylic acid is available from a number of commercial sources such as Spectrum Chemical, Gardena, Calif.
Upon spreading on skin (e.g., facial skin), the silicone gel releases the volatile liquid, delivers salicylic acid to the skin, and absorbs non-volatile excess skin oil present on the skin (e.g., the oil is absorbed by the oil-swellable silicone polymer and, if present, porous silica). The composition's ability to absorb sebum helps the skin maintain an environment that is less conducive to clogged pores, thereby, inhibiting the formation of com

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