Drug – bio-affecting and body treating compositions – Manicure or pedicure compositions
Reexamination Certificate
2001-04-10
2003-07-01
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Manicure or pedicure compositions
C424S443000, C514S946000
Reexamination Certificate
active
06585963
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to nail compositions and methods of administering such compositions. Accordingly, this invention covers the fields of pharmaceutical sciences, medicine, cosmetics, and related sciences.
BACKGROUND OF THE INVENTION
The health and overall physical appearance of fingernails and toenails may affect a person's ability to perform certain tasks, as well as their desire to engage in certain activities.
Unhealthy nails may be attributed to a variety of conditions, such as bacterial infection, improper grooming, neglect, and aging. Unhealthy nails may also be caused by fungal infections such as onychomycosis, a condition recognized by discoloration beneath toenails and fingernails along with pain when pressure is placed near or at the site of discoloration.
The disadvantage of systemic drug administration to treat localized peripheral conditions such as nail diseases are well known to include general ineffectiveness, and impact on other bodily systems. Because of ease in administration and comfort, topical treatments that treat nail conditions by imparting an active agent through the nail to the nail bed and other surrounding tissues are highly preferable to oral administration or to surgery.
Human nails, however, with respect to chemical composition and permeability, are more like hair than to stratum corneum of the skin. Nitrogen is the major component of the nail attesting to the nail's proteinaceous nature. The total lipid content of mature nail is 0.1 to 1.0%, while the skin stratum corneum lipid is about 10% w/w, and the level of hydration of the nail is considerably lower than the stratum corneum. The nail plate is about 100-200 times thicker than the stratum corneum and has a very high affinity for and capacity for binding and retaining many drugs. In fact, topical nail therapy has generally been ineffective for many conditions.
The nail plate is therefore too thick and too dense for a drug to penetrate at a practical rate. Although nail is similar to stratum corneum of the skin in that it is derived from epidermis, it is mainly composed of hard keratin (highly disulfide-linked) and is approximately 100-fold thicker than strateum corneum. For this reason, in order to deliver a sufficient amount of a drug into the nail plate, the permeability of the nail plate to the drug needs to be enhanced.
Several enhancers have been taught in the prior art to overcome the presence of high sulfide bonds in the nail plate. These enhancers include kerolytic agents such as urea and salicylic acid, to soften the nail plates, as disclosed in Konno et al. (EP 152281) and Sun et al. (U.S. Pat. No. 5,696,164), and reducing agents such as cysteine and its derivatives, which can break the disulfide bonds in keratin to increase the ability of the nail to hydrate, as disclosed in Olthoff et al. (EP 440298) and Sun et al. (U.S. Pat. No. 6,042,845). The prior art also teaches combining kerolytic agents and reducing agents to improve nail penetration.
Other reducing agents such as ammonium thioglycolate are also taught in the prior art. Puri (WO 86/00013) discloses that the condition of hair, skin and nails is improved by treatment with an aqueous ammonium thioglycolate solution, followed by treatment with a protein hydrolyzate. Rothman (WO 89/070793) discloses a protein-containing composition comprising reducing agents such as ammonium thioglycolate for treating kerotinous tissues.
Compounds with vasodilating action are also taught by the prior art. Bohn et al. (U.S. Pat. No. 6,007,798) discloses a nail varnish comprising a compound having a vasodilator action and a water-insoluble film-forming agent for treating growth disturbances of the nail.
Most of the inventions, as described above, have not been commercially successful. It is believed that compositions and methods for enhancing penetration of a nail agent and methods for treating nail conditions according to the present invention would be a significant advancement in the art.
SUMMARY OF THE INVENTION
The present invention provides nail compositions comprising a non-cellulosic polymeric carrier, a nail agent and an enhancer. These compositions are free of urea, sulfhydryl-containing amino acids, and vasodilators.
The present invention also provides methods for enhancing nail penetration of a nail agent using an enhancer of the present invention.
The present invention also provides methods of treatment of a nail condition comprising applying to the affected nails a nail composition of the present invention.
In one aspect of the present invention, the nail agent may include substances such as drugs, cosmetics, cosmeceuticals, or any mixtures thereof.
In a further aspect of the present invention, the nail agent is a drug, which is an azole, an allyl compound, or any combinations thereof.
In one aspect of the present invention, the composition may be in the form of a liquid, a solution, a suspension, a varnish, or a lacquer.
In another aspect of the present invention, the enhancer used in the composition may include, but not limited thereto, triacetin, lauramide diethanolamine, 1,8-epoxy-p-menthane, caproic triglyceride, cineole, dimethylsulfoxide (DMSO), dimethyl formamide (DMF), N,N-dimethylacetamide (DMA), propylene glycol, sorbitan, sorbitan monooleate, and N-methyl pyrrolidone, and any mixtures thereof.
In another aspect of the present invention, the non-cellulosic polymeric carrier may be a vinyl polymer or copolymer, including vinyl acetate and vinyl acetate copolymers, and vinyl ether polymers and copolymers.
In a further aspect of the invention, the polymeric carrier may be a copolymer of methylvinyl ether and maleic anhydride or a copolymer of methylvinyl ether and maleic acid.
The present invention also provides a nail composition as described herein that may be directly applied or used in connection with a bandage, which is adapted to topically administer the composition.
The present invention also provides a composition which may be used as a component of a nail kit, or a nail treatment kit, which may also include a pre-treatment composition comprising an enhancer of the present invention, including but not limited thereto propylene glycol, sorbitan monooleate, and N-methyl pyrrolidone, or any mixtures thereof.
There has thus been outlined, rather broadly, various features of the invention so that the detailed description thereof that follows may be better understood, and so that the present contribution to the art may be better appreciated. Other features of the present invention will become clearer from the following detailed description of the invention, taken with the accompanying claims, or may be learned by practice of the invention.
DETAILED DESCRIPTION
Definitions
Before the composition and methods are disclosed and described herein, it is understood that this invention is not limited to the particular process steps and materials disclosed herein, but is extended to the equivalents thereof as would be recognized by those ordinarily skilled in the relevant arts. It should be understood that the terminology employed herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention.
In describing and claiming the present invention, the following terminology will be used.
The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a drug” includes reference to one or more drugs, and reference to “an enhancer” includes reference to one or more of such enhancers.
The term “formulation” and “composition” may be used interchangeably herein.
The term “nail agent” refers to an agent, which exerts a desirable effect on a nail condition. The desirable effect may be a reduction of symptoms of a nail disease or condition, or treatment or cure, or both, of a nail disease or condition, or improving the appearance of a nail. Examples of nail agents include, but not limited thereto, drugs, cosmetics, and cosmeticeuticals.
The terms “
Quan Danyi
Ruiz Ana
Howard S.
Page Thurman K.
Thorpe North & Western LLP
Watson Pharmaceuticals, Inc.
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