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Preparations for topical skin use and treatmentRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Cosmetic, Antiperspirant, DentifricePreparations for topical skin use and treatment description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070148199, Preparations for topical skin use and treatment. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCES TO RELATED APPLICATIONS [0001] The present application is a divisional of U.S. patent application Ser. No. 10/660,101 filed Sep. 10, 2003, which claims priority to U.S. patent application Ser. No. 10/385,213, filed Mar. 10, 2003, which claims priority to U.S. Provisional Patent Application No. 60/363,386, filed Mar. 11, 2002 and U.S. Provisional Patent Application No. 60/439,862, filed Jan. 14, 2003. BACKGROUND OF THE INVENTION [0002] The present invention relates in general to preparations for topical skin treatment and, more particularly, to preparations comprising silicone matrices and hydrophilic carriers that provide sustained release of active agents. [0003] Silicones are compounds based on alkylsiloxane or organosiloxane chemistry and include polydimethylsiloxane materials that have been used as excipients and process aids in pharmaceutical applications. Some of these materials have attained the status of pharmacopoeial compounds. Known in the art is the use of such silicone compounds in controlled drug delivery systems, especially in applications where the association of specific properties is critical to meet the requirements of product design, i.e., biocompatibility and versatility. New long lasting drug delivery applications including implant, insert, mucoadhesive, transdermal, and topical forms draw on the unique and intrinsic properties of silicone. These delivery systems allow controlled release of active molecules with biologically appropriate kinetics to a targeted area, and prevent the adverse effects, such as peak dosages, low compliance, and drug degradation, commonly observed with traditional oral and parenteral medication. [0004] Transdermal drug delivery systems consist of drug containing adhesive patches, which adhere to intact skin up to 7 days. The patch design controls the release of the active agent, which is then carried through the organism by the circulatory system for a systemic activity. Using the skin as an entry point, the topical forms, which consist of an adhesive plaster or a film-forming and substantive material (e.g., cream or gel), are used for local treatment (muscle or skin disease). However, these transdermal drug delivery systems have not been incorporated into topical dressing applications such as wound dressings and ointments, wherein a biochemical agent dispersed within a silicone matrix is released onto skin or a wound to accelerate healing. [0005] Accordingly, the need remains in the relevant art for preparations that take advantage of the beneficial properties of silicone, and can provide sustained release of active agents. SUMMARY OF THE INVENTION [0006] The present invention meets that need by providing topical preparations comprising a silicone matrix, a hydrophilic carrier, and at least one active agent for release from the preparation. The active agents may be proteins, particularly enzymes such as hydrolases and glucose oxidase. The silicone matrix can comprise high Mw polydimethylsiloxanes, loosely or lightly cross-linked silicone elastomers, cross-linked silicone elastomers such as gels (fillerless elastomers), silica reinforced rubbers or foam, in which the cross-linking is achieved using addition and condensation cure systems, silicone pressure sensitive adhesives, and silicone-organic copolymers such as silicone polyamide. The preparations may be used to form dressings, ointments, and the like. [0007] In accordance with one aspect of the present invention, the preparation may comprise a thin film dressing that can be applied over the skin, including damaged tissue. In accordance with another aspect of the present invention, the preparation comprises a patch dressing. In accordance with still another aspect of the present invention, the preparation comprises a spread-on bandage dressing. In accordance with another aspect of the present invention, the preparation comprises an ointment. The thin film, the patch, the spread-on bandage, and the ointment can all be applied to the skin, over a surgical incision, a wound, or other skin lesion, abrasion, scrape, scratch, or other damaged tissue. The preparations may be occlusive to liquids and are effective in blocking microorganisms that cause infection from the skin surface. In one embodiment, active agents, such as protease, can be released from the preparations at the site of a wound for enzymatic debridement, clotting formation and clot removal, as well as in situ peroxide and/or peracid generation to accelerate wound healing at different stages thereof. [0008] In a preferred embodiment, the topical preparation comprises a mixture of a hydrophilic carrier containing an active agent that is dispersed throughout a silicone matrix. The mixture together with the silicone matrix forms the topical preparation of this embodiment of the present invention. The hydrophilic carrier is, for example, a solution of propylene glycol, which may be mixed with a water soluble or hydrophilic component such as, for example, polyvinyl alcohol ("PVA") or polyvinylpyrrolidone ("PVP"). The hydrophilic carrier and active agent mixture may form an internal phase that is an emulsion or dispersion, and this internal phase is disposed within the silicone matrix (external phase). Consequently, a silicone-based surfactant can be added to disperse or emulsify the internal phase into very small droplets and enhance the release of active agent. [0009] Accordingly, it is a feature of the present invention to provide topical preparations that are effective in providing controlled release of active agents to the skin. This and other features and advantages of the present invention will become apparent from the following detailed description of the invention. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0010] The following detailed description of the preferred embodiments of the present invention can be best understood when read in conjunction with the following drawings in which: [0011] FIG. 1 is a chart of the sustained release of protease from a preparation in accordance with an embodiment of the present invention. [0012] FIGS. 2A and 2B are charts showing the release/delivery of protease and lipase from a preparation in accordance with an embodiment of the present invention. [0013] FIGS. 3A-3C are charts showing the release of proteases from preparations having varying amounts of hydrophilic components. [0014] FIG. 4 is a chart showing the release rate of protease from preparations having varying silicone matrices. [0015] FIG. 5 is a chart showing the release rate of protease from preparations having a varying patch thickness. [0016] FIG. 6 is a chart showing the release of protease from an ointment formulation in accordance with an embodiment of the present invention. [0017] FIG. 7 is a chart showing the stability of protease in preparations in accordance with an embodiment of the present invention. [0018] FIG. 8 is a chart showing the stability of protease in preparations in accordance with another embodiment of the present invention. [0019] FIG. 9 is a chart showing the stability of protease in preparations in accordance with yet another embodiment of the present invention. [0020] FIG. 10 is a chart showing the stability of protease in preparations in accordance with an embodiment of the present invention. Continue reading about Preparations for topical skin use and treatment... 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