Method and plaster for preventing and/or treating the cases of finger-nail dysfunction and/or growth disorders

FIELD: medicine.

SUBSTANCE: method involves applying plaster having sealing protection layer and contact layer attached to mentioned protection layer. The contact layer is directly engageable with nail and optionally with surrounding skin areas. The contact layer is manufactured from adhesive material, agent for stimulating penetration through skin and/or nail, therapeutically effective quantity of pharmaceutically active antifungal agent and permissible additives.

EFFECT: enhanced effectiveness of treatment.

21 cl

 

The technical field to which the invention relates.

The present invention relates to the use of patches as a means for the prevention and/or treatment of disorders or abnormalities of nail growth and methods of prophylaxis and/or treatment of disorders and/or disorders of the nail growth using the patches.

The level of technology

Patches for the prevention and/or treatment of a dysfunction or disorders of the nail growth is not described in the literature, although there are patches for the treatment of, for example, onychomycosis (fungal onihei). For example, in the application WO-A-99/40955 described the patch-based sensitive to pressure adhesive matrix for the treatment of onychomycosis. The specified device for the treatment of fungal infections of the nails of the hands and feet includes a hermetic protective layer and a layer sensitive to pressure matrix in which is distributed evenly effective amount of an antifungal agent, in particular in a mixture with a chemical amplifier. Layer matrix includes a first surface bonded to the protective layer, and a second surface, intended for the diffusion contact with the infected nail and surrounding skin.

Treatment of onychomycosis is described in U.S. patent US-A-5464610, which describes a method of obtaining a sample of the patch using salicylic acid or her with the and, ether or mixtures thereof. The above sample patch attached to the carrier and contains salicylic acid, the content of which in the patch is from 10 to 80%, based on the mass of the sample.

Compositions and methods for pulling out the nails with the subsequent treatment of infections of the nail and the nail bed is described in U.S. patent US-A-5993790. The patent pending composition of nail Polish local actions, including nail Polish water-based preservative, urea and natural Supplement. Mentioned composition of nail Polish suitable for the treatment of fungal, yeast and bacterial infections of the nail and the nail bed.

In U.S. patent US-A-5753256 described the patch for the treatment of fungal infections of the nails, and the patch includes a flexible protective film, a layer of matrix on the basis of acrylate polymer, which is firmly attached to the above-mentioned protective film and which includes an active compound selected from the group: miconazole, econazole, isoconazole, tioconazole, terconazole, oxiconazole, ketoconazole, Itraconazole, tolciclate, Albertin, haloprogin, griseofulvin, ciclopirox, terbinafine and salts of these compounds.

In the patent RU 2076754, which is the closest analogue of the present invention, described is a method of treatment of onychodystrophy, namely, that the affected nail plate remove the pulsed emission of CO2-laser.

The objective of the present invention is to develop a new more simple, effective, painless, non-invasive method of prophylaxis and/or treatment of disorders or abnormalities in the structure and/or nail growth, not only caused by onychomycosis is carried out by applying a patch.

This task is achieved by applying the patch described in the independent claims, and method of prevention and/or treatment using the above patch. Other advantages and characteristics, aspects and details are disclosed in the dependent claims, the description and the examples of this application.

Disclosure of inventions

The present invention is directed to application of the patch, which includes a contact layer made with the possibility of direct (close) contact with the nail and optionally with the surrounding skin, containing an adhesive, at least one amplifier penetration through the skin and/or nail, a therapeutically effective amount of at least one pharmaceutically active agent included in the composition mentioned contact layer, and at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants as a means for the prevention and/or treatment of onychodystrophy, except onychomycosis.

In another embodiment from which retene patch has a protective layer, and the contact layer attached to the above-mentioned protective layer.

In a preferred embodiment, the aforementioned protective layer of plaster is sealed with a protective layer.

Mentioned power of penetration through the skin and/or nails, preferably selected from the group comprising fatty acids, esters of fatty acids, amides of fatty acids, fatty alcohols, 2-(2-ethoxyethoxy)ethanol, esters of glycerin, monolaurate glycerin, propylene glycol, polyethylene glycols, unsaturated poliglecaprone glycerides, saturated polyglycolide, partial glycerides of ricinoleic acid, α-hydroxy acid, a sulfoxide, decylmethacrylate, pyrrolidone, salicylic acid, lactic acid, myristol, isopropylmyristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipids and proteolytic enzymes. However, the contents of the amplifier penetration through the skin and/or nail in the composition of the contact layer is from 0.7 to 6% based on the weight of the contact layer, and the content of additives in the composition of the contact layer is from 15 to 20% based on the weight of the contact layer.

Pharmaceutically active agent in the composition of the patch is chosen from the group including fluconazole (Diflucan), butoconazole, enilconazole, fenticonazole, sulconazole, naftopidil, clioquinol, iodoquinol, imaplogin, griseofulvin is h, terbinafine (Lamisil), clotrimazole, Itraconazole (Sempera), tioconazole, miconazole, tolnaftate, pyragollole, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin b, nystatin, tolciclate, Albertin, ketoconazole, ciclopirox (Batrafen), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents. The content mentioned pharmaceutically active agent in the adhesive is from 0.01 to 5 mg/cm2patch.

In one embodiment of the invention the adhesive composition of the patch selected from the group including acrylic adhesives, rubber adhesives and silicone adhesives, with a preferred content of the adhesive 80 to 90% based on the weight of the contact layer.

The invention also relates to a method for prevention and/or treatment of onychodystrophy, except onychomycosis carried out in accordance with the above-described application. According to the claimed method, the above-mentioned adhesive paste to the nail and not necessarily to others the nail to the skin.

In another embodiment of the invention the use of this patch is carried out in combination with systemic treatment of ingrown nails, nail psoriasis, melanonychia striped bodies, diseases of the white bands (spots), neurodermatitis, eczema, chronic onihei, discolored nails, thickened nails, Rosmalen and peeling nails, bending nails, koilonychia, sclerenchyma, onychogryposis, hyperonymy, onycholysis, anarctica, trachyonychia and other forms of onychodystrophy, except onychomycosis.

The implementation of the invention

The present invention relates to patches for the prevention and/or treatment of disorders or abnormalities in the structure and/or nail growth. The patches according to the invention, include a contact layer made with the possibility of direct contact with the nail and optionally with the surrounding skin.

The said layer contains:

a) an adhesive

b) at least one amplifier penetration through the skin and/or nail,

b) a therapeutically effective amount of at least one pharmaceutically active agent included in the composition mentioned contact layer

g) at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants.

The invention also includes patches containing two or more layers. In a preferred variant embodiment of the present invention described layer, which is divided into a protective layer and a contact layer, and a contact layer attached to the protective layer and is made with the possibility of direct contact with the nail and optionally with the surrounding phase is mi skin. Mentioned contact layer includes:

a) an adhesive

b) at least one amplifier penetration through the skin and/or nail,

b) a therapeutically effective amount of at least one pharmaceutically active agent included in the composition mentioned contact layer

g) at least one additive selected from the group comprising binders, softeners, plasticizers, solvents, fillers and/or antioxidants.

An elastic protective layer captures and secures the patch to the nail and the skin to enhance migration of the contact layer in the nail, nail bed and surrounding skin areas. Moreover, the protective layer protects the contact layer from contamination. In a preferred embodiment of the invention, the above patch includes colorless protective layer or a protective layer of an amber color. In another preferred variant of embodiment of the invention uses an elastic and/or sealed with a protective layer. The patch is characterized by sufficient flexibility to completely cover the affected nail, even if the nail is characterized by a rough surface.

Another variant embodiment of the invention includes a contact layer, which is divided into Central (middle) layer and the layer containing the drug. The Central layer is designed to direct kontaktierung the protective layer and the layer containing the drug, and the Central layer does not contain a pharmaceutically active component, and a layer containing a medicinal product, includes a therapeutically effective amount of pharmaceutically active agent, which is described below. The protective layer preferably made of polyethylene such as low density polyethylene, LDPE, Plastotrans), polypropylene, polyurethane, complex, polyester (such as Revatrans, TriconGmbH, Freiburg), polyvinylchloride foil Guttagena PVC NBR (such as Guttagena WK 68, Kalle Pentaplast, Germany), cotton, cotton/viscose, silk, polyethylene terephthalate (such as Hostaphan RN 36 sil; Hostaphan RN 100 sil, Loparex, Apeldorn, the Netherlands), copolymers of ethylene and methacrylic acid and/or mixtures of these materials. Most preferred are organosilicon polymers and/or copolymers.

The term "contact layer", used in this context, means a biocompatible adhesive containing the aforementioned pharmaceutically active agent, and optional additional components and/or additives with specific biological functions, provide and maintain at a constant level migration and penetration of pharmaceutically active agent into the nail, nail bed and surrounding skin areas. A contact layer is firmly connected with the protective layer, preferably with elastic GE is metonym protective layer.

In the above-mentioned adhesive can contain a large enough number mentioned pharmaceutically active agent, and the adhesive preferably is a gel-like or similar rubber adhesives adhesive, and the adhesive provides and maintains a continuous flow of pharmaceutically active agent through the skin and nail over an extended period of time, preferably within one week.

The patch of the present invention can be made in any suitable shape, for example round, oval, rectangular or square. The preferred dimensions of the patch are 0.5 cm2to 0.85 cm2, 1.5 cm2, 2.3 cm2, 2.5 cm2and 4.0 cm2.

Suitable therapeutically effective amount mentioned pharmaceutically active agent is 0.005 to 10 mg/cm2patch, preferably 0.01 to 5 mg/cm2patch, more preferably 1-4 mg/cm2and most preferably 1-2 mg/cm2patch.

Such antifungal agents can be divided into 5 groups, including the polyene, such caomparison b and nystatin; azoles, and, above all, the imidazoles, such as miconazole and sertaconazole; triazoles, such as Itraconazole, fluconazole, and voriconazole; allylamine, such as naftifine and terbinafine; morpholines such as amorolfine, and benzofuro is s, such as griseofulvin.

The patch of the present invention contains a pharmaceutically active amount of at least one pharmaceutically active agent such as fluconazole (Diflucan), butoconazole, enilconazole, fenticonazole, sulconazole, naftopidil, clioquinol, iodoquinol, imaplogin, griseofulvin, terbinafine (Lamisil, Novartis Pharma), clotrimazole, Itraconazole (Sempera, Janssen Pharmaceutical), tioconazole, miconazole, tolnaftate, pyragollole, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin b, nystatin, tolciclate, Albertin, ketoconazole, ciclopirox (Batrafen, Aventis Pharma), amorolfine, bifonazole, the sodium pyrithione, salicylic acid and/or salts of these agents.

In the art these pharmaceutical agents used for bandages and medicines patches used in the treatment of fungal nail infections, i.e. onychomycosis. In the present invention is first described using the aforementioned pharmaceutically active agents for the prevention and/or treatment of disorders or abnormalities of the structure of nails and/or nail growth and destruction of the structure of the nail, not related to kanamitsu. First of all described the prevention and/or treatment of onychodystrophy not related to onychomycosis.

Onychomycosis, as an infectious disease of the nails, is a subgroup onychodystrophy way fungal infections are excluded from the scope of the present invention.

Onychodystrophy includes a number of dysfunctions and disorders of the structure of the nail, such as ingrown nails, melanonychia striped bodies, disease, white stripes, chronic paronychia, discolored nails, alasannya nails, bending nails, koilonychia, sclerenchyma, onychogryposis, hypertrophy of the nail, onycholysis, anaorexic, trachyonychia, delamination and splitting nails.

Onychodystrophy, which may be caused or mediated by fungal infections (onychomycosis)are excluded from the scope of the present invention.

The most famous group of onychodystrophy, except caused by onychomycosis-mediated skin diseases such as atopic dermatitis (atopic eczema) and psoriasis. Moreover, onychodystrophy can cause or mediate bacterial or viral infection.

Onychodystrophy can also cause medicines, such as antibiotics, anticoagulants, ACE inhibitors, beta-blockers, thiazides, cytostatics, etc. Another reason for onychodystrophy are systemic diseases, such as beriberi, renal and cardiac failure. Another cause of onychodystrophy may be contact with chemical compounds such as acids, bases, oxidizing agents, etc. which leads to burns Ave is Ghanem, and physical effects that lead to mechanical damage to the nail plate. Finally, there are unknown factors that cause dysfunction and/or disrupting the structure of the nails.

The term "nail", as used in the present description, means the nails on the hands and feet mammals, in particular humans.

In a preferred variant embodiment of the present invention, the above patch includes a contact layer that is designed to almost completely seal the damaged nail, which leads to the almost complete exclusion of air. Moreover, the patch of the present invention may, in particular, contain additional oxygen scavenger. Suitable oxygen scavengers include chelate compounds or complexes of transition compounds, for example, salicylic acid, and/or a salicylate, and/or polycarboxylic acids, or oxidizing organic acids or alcohols in combination with a catalyst.

Suitable power of penetration through the skin and/or nail is well known to experts in the art and may be selected from the group comprising fatty acids, esters of fatty acids, fatty alcohols, 2-(2-ethoxyethoxy)ethanol, esters of glycerin, monolaurate glycerin, propylene glycol, polyethylene glycols, unsaturated poliglecaprone g is iceride (Labrafil M1944CS, Gattefosse), saturated polyglycolide (Labrasol, Gattefosse), partial glycerides of ricinoleic acid (Softigen, Huls), Labrafac HydroWL1219 (Gattefosse), Estasan (Gattefosse), α-hydroxy acid, a sulfoxide, decylmethacrylate, pyrrolidone, salicylic acid, lactic acid, myristol, isopropylmyristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipids, Transcutol (Gattefosse), Eutanol (Henkel), as well as mixtures containing oleic acid/2-(2-ethoxyethoxy)ethanol, oleic acid/Labrafil and oleic acid/Labrafac (Gattefosse), preferably in a ratio of about 1:1, etc. as penetration enhancers can also be used enzymes, such as proteolytic enzymes, which accelerate the penetration of chemical compounds through hardened nail or glue fabric.

Examples of the most well-known fatty acids include capric, lauric, myristic, palmitic, margaric, stearic, arachnid, beenbuy, lignocellulose, myristoleic, palmitoleic, petroselinic, oleic, vaccinology, gadolinium, rondonuwu, urinary, Neronova, linoleic, γ-linoleic acid, di-Homo - γ-linolenic acid, arachidonic acid, 7,10,13,16-docosatetraenoic, 4,7,10,13,16-docosapentaenoic, α-linolenic, stearidonic, 8,11,14,17-eicosatetraenoic, 5,8,11,14,17-eykozapentaenovuyu, 7,10,13,16,19-docosapentaenoic, 4,7,10,3,16,19-docosahexaenoic, 5,8,11-eicosatrienoic, terminoloy, Intellinova, stearinovuyu, 6,9-octadecenoyl, prolinnova, krupenikov, gastrinoma, t8,t10-octadecadiene-12-new, 5,8,11,14-eicosatetraenoate, Cherepanovo, auxinitwindow, brussilov and taseevo acid. Also use esters of lower alilovic esters and amides of the aforementioned fatty acids or their corresponding alcohols. Esters of glycerol may also contain one or more of the mentioned fatty acids.

Power of penetration through the skin and/or nail is maintained at a constant level and increases the penetration and passage mentioned pharmaceutically active agent through the skin in the nail and nail bed. The term "power penetration" refers to the increase of the permeability of biological membranes, that is, skin or nails. Power of penetration through the skin and/or nail is usually used to increase the speed of penetration of the pharmaceutically active component through the membrane. The effect of amplifier penetration is determined with the use of the device, provided with a diffusion cell, as described in article Merrit et al. (Diffusion Apparatus for Skin Penetration (Diffusion device for penetration through the skin), J.Controlled Release, 1984, 1, 161-162), measurement of the rate of diffusion pharmaceutically active ingredient through the skin of animals or humans.

Effective if estvo amplifier penetration through the skin and/or nail means the number, sufficient to provide the required increase in membrane permeability and, correspondingly, the desired depth of penetration and passage of a sufficient amount mentioned pharmaceutically active component.

The contents of the amplifier penetration through the skin and/or nail into the plaster of the present invention in the composition of the contact layer is from 0.1 to 30% based on the weight of the adhesive, preferably from 0.1 to 15% by weight of the adhesive, more preferably from 0.5 to 10% and most preferably 0.7 to 6% based on the weight of the contact layer.

The patch of the present invention, in particular, contains an additional additive which is chosen from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants.

The content of the above additives or mentioned additives, if present, in the composition of the layer is from 2 to 80%, based on the weight of the contact layer, preferably from 5 to 40% based on the weight of the contact layer, more preferably from 8 to 30%, even more preferably from 12 to 25% and most preferably 15 to 20% based on the weight of the contact layer.

"Binder" refers to substances that bind or "glue" powders and give them cohesively due to the formation of the adhesion layer, which serves as an additional "adhesive" to the notizie. Suitable binding agents include non-natural sugars, natural sugars such as sucrose, starches from wheat, rice and potatoes, synthetic and natural gums, such as Arabian gum, gelatin and tragakant derived from marine algae, such as Aleynikova acid, sodium alginate and originalone-calcium, cellulose derivatives such as methylcellulose, sodium carboxymethyl cellulose and hypromellose, polyvinylpyrrolidone and inorganic compounds such as magnesium silicate-aluminum, polyethylene glycol and waxes.

The content of the binder, if present in the adhesive is from about 1 to 50% based on the weight of the adhesive, preferably from about 10 to about 50% based on the weight of the adhesive, more preferably from about 20 to about 50% based on the weight of the adhesive and most preferably from about 30 to about 40%.

Suturing is chosen from the group comprising cross-linking agents, such as aluminum acetylacetonate, a copolymer of acrylate and vinyl acetate, acetone aluminum, titanium acetylacetonate, acetone titanium and succinic acid.

The content of suturing, if they are present in the adhesive is from about 0.01 to 30%, based on the weight of the adhesive, preferably from priblizitel is but 0.1 to about 50% based on the weight of the adhesive, more preferably from about 10 to about 50% and most preferably from about 30 to about 40% based on the weight of the adhesive.

Softening agent selected from the group including dibutylsebacate (DBS), Macrogol (Clariant, Frankfurt, Germany), etc.

The content of the softener, if present in the adhesive is from about 0.001 to 25%, based on the weight of the adhesive, preferably from about 0.01 to about 10% based on the weight of the adhesive, more preferably from about 0.1 to about 6% and most preferably from about 0.5 to about 3% based on the weight of the adhesive.

Suitable solvents for the patch of the present invention are selected from the group comprising purified water, ketones such as acetone, butanone, 2-pentanone, 3-pentanone; alcohols, such as ethanol, propanol, isopropanol, butanol, sec-butanol, tert-butanol; esters such as ethyl ester acetic acid, propyl ester acetic acid, etc. moreover, it is possible to use mixtures of these solvents. Suitable co-solvents can be used in a mixture with the above-mentioned solvents or mixtures of solvents, and such co-solvents are selected from the group comprising lactic acid, salicylic acid, succinic acid, urea, Milyol 812 (Chemische Werke Huls, Marl, Germany), triglycerides, etiloleat, glycerylmonostearate, olein, oleate, Macrogol 6000 and lecithin.

The content of the solvent or the total content of solvents and co-solvents, if they are present in the adhesive is from about 0.5 to 70%, based on the weight of the adhesive, preferably from about 3 to about 60%, based on the weight of the adhesive, more preferably from about 10 to about 50%, even more preferably from about 20 to priblizitelen 40% and most preferably from about 10 to about 30% based on the weight of the adhesive.

The fillers are selected from the group including silicon dioxide, silicic acid, preferably colloidal silica or colloidal silicic acid, lactose, Aerosil, such as Aerosil 200 (Deguss-Huls, Frankfurt, Germany), starch, Bentonit (Sudchemie, Mannheim, Germany), etc.

The content of fillers, if they are present in the adhesive is from about 0.01 to 15%, based on the weight of the adhesive, preferably from about 0.1 to about 10% based on the weight of the adhesive, more preferably from about 0.3 to about 6% and most preferably from about 0.5 to about 3% based on the weight of the adhesive.

As an example of a suitable antioxidant can be in order to mention equivalent (wave geotechnologies). Antioxidants are well known to experts in the art and are selected from well-known antioxidants.

The content of antioxidants, if they are present in the adhesive is from about 0.001 to 10% in the calculation of the mass of the adhesive, preferably from about 0.005-about 6%, based on the weight of the adhesive, more preferably from about 0.01 to about 3% and most preferably from about 0.05 to about 1% based on the weight of the adhesive.

Suitable adhesives for the adhesive of the present invention include acrylic copolymers, also known as "acrylic adhesives", such as National Starch Durotak 80-1196, National Starch Durotak 387-2825 or Monstano Gelva 737, polyacrylamide, adhesives based on rubber, also called "rubber adhesives, such as polyisobutylene (PIB) (for example, Adhesive Research MA-24), polyisoprene, copolymers of styrene and isoprene or urethane rubbers, and adhesives, silicone-based, so-called "silicone adhesives, such as Dow Bio PSA.

Adhesives that can be used in the present invention are a polymer, preferably acrylate copolymer. Suitable monomers or mixture of monomers to obtain the aforementioned acrylate polymer include methyl acrylate, methyl methacrylate, butyl acrylate, butylmethyl is at, isooctadecyl, isooctylphenyl, aminoalkylsilane, aminoalkylation, copolymers of aminoalkylsilane (such as Eudragit E 100, Eudragit RL, Eudragit RS, Eudragit NE 30 D, manufactured by Rohm, Degussa-Huls Group), hydroxyethylacrylate, hydroxyethylmethacrylate, 2-hexyl acrylate, 2-ethylhexylacrylate, acrylic acid, methacrylic acid, vinyl acetate and glycidylmethacrylate. Adhesives based on acrylate produced by National Starch Chemical B.V., Zutphen, NL, under the trade name Durotak. Examples of a given class of products include Durotak 280-2287 (51%solution or solid), Durotak 326-1753 (37%solution or solid), Durotak 280-1753 (33%solution or solid), Durotak 901-1052 (48%solution or solid), Durotak 80-1196 (solid) and Durotak 387-2825 (50%solution).

The content of the adhesive patch of the present invention is from 40% to 95%, based on the weight of the adhesive, preferably from 60 to 90%, based on the weight of the adhesive, more preferably from 70% to 90% calculated on the weight of the plaster and most preferably from 80% to 90% calculated on the weight of plastira.

The present invention includes combination therapy, in which the patch is used in combination with systemic treatment of onychomycosis or other systemic treatment of dysfunctions or disorders struture and/or nail growth.

The mentioned combination therapy what is most suitable for prophylaxis and/or treatment of onychomycosis, ingrown nails, nail psoriasis, melanonychia striped bodies, disease, white stripes, eczema, chronic onihei, discolored nails, thickened nails and onychodystrophy.

The term "adhesive"as used in this context, means any device that can be applied to the nail and which includes a contact layer, which is placed on the nail surface pressure. Suitable patches include patches or pre-molded film based rubbers, acrylic, urethane polymers, silicone materials, simple polyvinylbutyral, gels and impregnated microporous membranes. The above patch can also be combined with an artificial nail or incorporated in or formed in the shape of the artificial nail to improve the appearance.

The term "adhesive"as used in this context, means a product containing at least one pharmaceutically active agent, in particular in a mixture with suitable additives and/or binders in the composition of the device of the patch.

In the present invention is also described using the patch for the prevention and/or treatment of disorders or abnormalities in the structure and/or nail growth percutaneous method or through a layer of nail adhesion of plaster to the nail and do not necessarily environmentally-mentioned nail skin, and the patch which concludes layer, made with the possibility of direct contact with the nail and optionally with the surrounding skin. Mentioned layer includes:

a) an adhesive

b) at least one amplifier penetration through the skin and/or nail,

b) a therapeutically effective amount of at least one pharmaceutically active agent included in the composition mentioned contact layer

g) at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants.

Instead of the above-mentioned patch you can also use the patch comprising 2 or more layers, for prophylaxis and/or treatment of disorders or abnormalities of the structure of nails and/or nail growth, adhesion of plaster to the nail and not necessarily to others mentioned the nail to the skin, and the patch includes:

a) a protective layer;

b) a contact layer attached to the protective layer and intended for direct contact with the nail and optionally with the surrounding skin;

moreover, the aforementioned contact layer includes:

AA) an adhesive

BB) at least one amplifier penetration through the skin and/or nail,

C) a therapeutically effective amount of at least one pharmaceutically active agent included in the composition mentioned contact layer

gg) at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants.

One important aspect of the present invention is the fact that with the patches there is no need for drilling at least one hole in the nail and/or daily scraping of the nail. Another advantage of the present invention is the simple and convenient way of applying patches, favorable for patients.

The patch of the present invention can be used in combination with systemic treatment of dysfunctions or disorders of the structure and/or nail growth, such as onychomycosis, ingrown nails, nail psoriasis, melanonychia striped body, disease of the white stripes, eczema, chronic onychia, discolored nails, thickened nails and onychodystrophy.

The present invention describes a method of delivering a sufficient amount of at least one pharmaceutically active agent into the affected nail, nail bed and surrounding tissue percutaneous method and/or through a layer of nail adhesion of plaster to the nail and not necessarily to others the nail to the skin, for the treatment of dysfunctions or disorders of growth above the nail.

One of the advantages of the above-mentioned method according to the present invention is one which by the fact, when using this method there is no need for drilling at least one hole in the nail and/or daily scraping of the nail.

The method according to the present invention can also be used in combination with systemic treatment of onychomycosis or other types of systemic treatment of dysfunctions or disorders of the structure and/or nail growth. It is shown that the most effective is the combination of the method according to the present invention with systemic treatment of onychomycosis or other types of systemic treatment of dysfunctions or disorders.

Examples

The following examples are intended to illustrate the present invention, and presents ways to embodiments of the present invention do not limit the scope of the present invention.

Patches or nail stickers preferably include a protective layer and/or remove the gasket. The protective layer, if present, preferably made of PVC, such as foil Guttagena PVC NBR, and remove the gasket preferably izgotovlenie of PET (polyethylene terephthalate), such as PET / PET foil, both sides of which siliconserver (100 μm).

Example 1

Patch 1: Connection comprising a contact layer for patch area of 1.0 cm2

No.Connection Concentration
1Sertaconazole1.4 mg
2Durotak 387-28258,80 mg
3Lactic acid0.11 mg
4Aerosil 2000.33 mg
5Acetylacetonate aluminum0.11 mg

The effectiveness of the patch was tested on patients suffering from onychodystrophy of fingernails.

In the beginning of treatment, one patient was observed in 40% of dystrophic nail inclusions, the content of which is reduced to 15% after 24 weeks of treatment with the patch. Another patient treated for 24 weeks, while the area of dystrophic nail inclusions is reduced from 20 to 5%. The third patient was also subjected to treatment with the patch for 24 weeks, with the area of the affected nail is reduced in size from 30 to 10%.

During treatment, some patients exposed to treatment, there are only minor side effects. Mentioned side effects are characterized by flaking of the tissues surrounding the nail.

One of the advantages of the mentioned patches is that the patch can be replaced once a week, and, for example, not every day. Thus, the excess antifungal agent that is used is to ensure a sufficient amount of an antifungal agent in the adhesive layer of the patch, still present in the above-mentioned layer after using the patch during the week. The residual amount of the antifungal agent in the adhesive has a preventive effect and prevents the development of secondary infections, and reduces the risk of Contracting third parties from the patient.

When testing patches 2-6, obtained as described in examples 2-6, obtained similar results.

The duration of treatment in some cases is 1 year or more. Usually the period of treatment lasts from one to several months, provided weekly replacement patch.

Example 2

Patch 2: Composition to obtain a patch with an area of 1 cm2

No.ConnectionNumber
1Clotrimazole1-2 mg
2The solution Durotak 87-2852 (36,1%)of 22.2 mg
3Ethyl alcohol (96%)2 mg

Connections are weighed and mixed to a homogeneous state. The mixture is applied on a sheet of siliconized polyester (thickness 75 μm, firms Loparex, Apeldom, NL). The thickness of the wet layer of the adhesive film 400 μm. After drying at 60°C for 15 min in a drying Cabinet and incubation at 25°C for 12 h cleave the cover layer polyolefin film thickness of 50 μm (firm Cotran No 9722, 3M-Medica, Borken, Germany).

In the end from a sheet of self-adhesive stamp patch on the size of the nails of the fingers or toes.

Example 3

Patch 3: Composition to obtain a patch with an area of 1 cm2

No.ConnectionNumber
1Ciclopirox1.8 mg
2The solution Durotak 36-6172 (57,1%)14 mg
3n-Heptane2 mg

Connections are weighed and mixed to a homogeneous state. The mixture is applied on a sheet of siliconized polyester (thickness 75 μm, firms Loparex, Apeldom, NL). The thickness of the wet layer of the adhesive film 400 μm. After drying at 60°C for 15 min in a drying Cabinet and incubation at 25°C for 12 h adhesive cover layer polyolefin film thickness of 50 μm (firm Cotran No 9722, 3M-Medica, Borken, Germany).

In the end from a sheet of self-adhesive stamp patch on the size of the nails of the fingers or toes.

Example 4

Patch 4: Composition to obtain a patch with an area of 1 cm2

No.ConnectionNumber
1Terbinafine1.5 m, the
2Durotak 87-2100 (52,7%)15,1 mg
3Ethyl alcohol (96%)3 mg

Connections are weighed and mixed to a homogeneous state. The mixture is applied on a sheet of siliconized polyester (thickness 75 μm, firms Loparex, Apeldom, NL). The thickness of the wet layer of the adhesive film 400 μm. After drying at 70°C for 15 min in a drying Cabinet and incubation at 25°C for 12 h adhesive cover layer polyolefin film thickness of 50 μm (firm Cotran No 9722, 3M-Medica, Borken, Germany).

In the end from a sheet of self-adhesive stamp patch on the size of the nails of the fingers or toes.

Example 5

Patch 5: Composition to obtain a patch with an area of 1 cm2

No.ConnectionNumber
1Amorolfine1.7 mg
2The solution Durotak 387-2516 (42,5%)18,8 mg
3Ethyl alcohol (96%)3 mg

Connections are weighed and mixed to a homogeneous state.

The mixture is applied on a sheet of siliconized polyester (thickness 75 μm, firms Loparex, Apeldom, NL). The thickness of the wet layer of the adhesive film 400 μm. After drying Ave is 60° C for 15 min and at 80°C for 10 min in an oven and after cooling the adhesive cover layer polyolefin film thickness of 50 μm (firm Cotran No 9722, 3M-Medica, Borken, Germany).

In the end from a sheet of self-adhesive stamp patch on the size of the nails of the fingers or toes.

Example 6

Patch 6: Connection for the contact layer of the patch area of 1.0 cm2

No.ConnectionConcentration
1Eudragit E 10042.2
2Fluconazole17,7 g
3Dibutylsebacate19,0 g
4Succinic acid3.8 g
5Acetone21,0 g
6Isopropanol2.3 g
7Ethanol11,7 g

Equipment

The solution was prepared in the reaction apparatus with a high speed stirrer. As a mixer, you can use a disk stirrer to dissolve, for example, which provides intensive stirring at high viscosity. In laboratory scale coating and drying is carried out in the laboratory for cell coating is about integrated dryer (LTSV/LTF, company W. Mathis AG, Switzerland).

Method for producing composition

Acetone, isopropanol and ethanol is loaded into the apparatus with stirring, then added in several portions Eudragit E 100 within 90 minutes by dissolving Eudragit E 100 and the stirrer set at the mixing speed at which precluded the formation of sludge. Quickly add dibutylsebacate and stirring is continued for another 20 minutes Then a solution of the polymer portions add succinic acid under vigorous stirring. When you are finished adding succinic acid to the polymer solution is stirred for another 20 minutes

The coating is carried out with the use of the final polymer solution under the following conditions:

Coverage: approximately 100 g of the above polymer solution is applied on the protective layer foil (thickness 15 μm, firms Revatrans MN, Tricon GmbH Freiburg) using a rotary scraper-blades with a gap of 200 μm.

Drying: Drying is carried out at 60°C for 10 min in stroyrem the air flow of 1500 m3/h, the flow of exhaust air is 80 m3/PM

1. Applying a patch with a contact layer made with the possibility of direct contact with the nail and optionally with the surrounding skin, and containing an adhesive, at least one amplifier penetration through the skin and/or nail, a therapeutically effective the active amount of at least one pharmaceutically active antifungal agent, included in the aforementioned contact layer, and at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants as a means for the prevention and/or treatment of onychodystrophy, except onychomycosis.

2. The use according to claim 1 patch, optionally with a protective layer, to which is attached a contact layer.

3. The use according to claim 2 patch, in which the aforementioned protective layer is sealed with a protective layer.

4. The use according to any one of claims 1 to 3 patches in which the power of penetration through the skin and/or nail is selected from the group comprising fatty acids, esters of fatty acids, amides of fatty acids, fatty alcohols, 2-(2-ethoxyethoxy)ethanol, esters of glycerol, monolaurate, propylene glycol, polyethylene glycols, unsaturated poliglecaprone glycerides, saturated polyglycolide, partial glycerides of ricinoleic acid, α-hydroxy acid, a sulfoxide, decylmethacrylate, pyrrolidone, salicylic acid, lactic acid, myristol, isopropylmyristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipids and proteolytic enzymes.

5. The use according to any one of claims 1 to 3 patches in which the contents of the amplifier penetration through the skin and/or nogot is in the composition of the contact layer is from 0.7 to 6% based on the weight of the contact layer.

6. The use according to any one of claims 1 to 3 patches in which the content of additives in the composition of the contact layer is from 15 to 20% based on the weight of the contact layer.

7. The use according to any one of claims 1 to 3 patches, in which the pharmaceutically active antifungal agent selected from the group including fluconazole (Diflucan), butoconazole, enilconazole, fenticonazole, sulconazole, naftopidil, clioquinol, iodoquinol, imaplogin, griseofulvin, terbinafine (Lamisil), clotrimazole, Itraconazole (Sempera), tioconazole, miconazole, tolnaftate, pyragollole, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin b, nystatin, tolciclate, Albertin, ketoconazole, ciclopirox (Batrafen), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents.

8. The use according to any one of claims 1 to 3 patches, in which the content mentioned pharmaceutically active agent in the adhesive is from 0.01 to 5 mg/cm2patch.

9. The use according to any one of claims 1 to 3 patches, which adhesive selected from the group including acrylic adhesives, rubber adhesives and silicone adhesives.

10. The use according to any one of claims 1 to 3 patches, in which the content of the adhesive is from 80 to 90%, based on the weight of the contact layer.

11. The method of prevention and/or treatment of onychodystrophy, except onychomycosis, is causesa fact, that nail and optional for others referred to the nail skin paste the patch with a contact layer, directly in contact with the nail and optionally with the surrounding skin, and containing an adhesive, at least one amplifier penetration through the skin and/or nail, a therapeutically effective amount of at least one pharmaceutically active antifungal agent included in the composition mentioned contact layer, and at least one additive selected from the group comprising binders, staplers, softeners, solvents, fillers and/or antioxidants.

12. The method according to claim 11, wherein the patch has an additional protective layer to which is attached a contact layer.

13. The method according to item 12, wherein the protective layer is sealed with a protective layer.

14. The method according to any of § § 11 to 13, characterized in that the amplifier penetration through the skin and/or nail is chosen from the group comprising fatty acids, esters of fatty acids, amides of fatty acids, fatty alcohols, 2-(2-ethoxyethoxy)ethanol, esters of glycerol, monolaurate, propylene glycol, polyethylene glycols, unsaturated poliglecaprone glycerides, saturated polyglycolide, partial glycerides of ricinoleic acid, α-hydroxyacids, dimetilan foxed, decelerated, pyrrolidone, salicylic acid, lactic acid, myristol, isopropylmyristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipids and proteolytic enzymes.

15. The method according to any of § § 11 to 13, characterized in that the contents of the amplifier penetration through the skin and/or nail in the composition of the contact layer is from 0.7 to 6% based on the weight of the contact layer.

16. The method according to any of § § 11 to 13, characterized in that the content of additives in the composition of the contact layer is from 15 to 20% based on the weight of the contact layer.

17. The method according to any of § § 11 to 13, characterized in that the pharmaceutically active agent is selected from the group including fluconazole (Diflucan), butoconazole, enilconazole, fenticonazole, sulconazole, naftopidil, clioquinol, iodoquinol, imaplogin, griseofulvin, terbinafine (Lamisil), clotrimazole, Itraconazole (Sempera), tioconazole, miconazole, tolnaftate, pyragollole, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin b, nystatin, tolciclate, Albertin, ketoconazole, ciclopirox (Batrafen), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents.

18. The method according to any of § § 11 to 13, characterized in that the content mentioned pharmaceutically active agent in the adhesive is from 0.01 to 5 mg/cm2p is Asteria.

19. The method according to any of § § 11 to 13, characterized in that the adhesive is chosen from the group comprising acrylic adhesives, rubber adhesives and silicone adhesives.

20. The method according to any of § § 11 to 13, characterized in that the content of the adhesive composition of the patch is from 80 to 90%, based on the weight of the contact layer.

21. The method according to any of § § 11 to 13, characterized in that the use of the above patch is carried out in combination with systemic treatment of ingrown nails, nail psoriasis, melanonychia striped bodies, diseases of the white bands (spots), neurodermatitis, eczema, chronic onihei, discolored nails, thickened nails, splitting and peeling nails, bending nails, koilonychia, sclerenchyma, onychogryposis, hyperonymy, onycholysis, anarctica, trachyonychia and other forms of onychodystrophy, except onychomycosis.



 

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EFFECT: valuable medicinal properties of compositions.

27 cl, 2 tbl, 10 dwg, 4 ex

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