KR20030072592A - Therapeutic film forming composition and treatment system - Google Patents

Abstract

One or more therapeutic ingredients for application to the nail and / or skin surface, which may be applied independently or, if desired, may be applied in conjunction with an easily applied holding or support member for direct transfer of heat to the application site. By providing the incorporated film forming compositions, an easily applied, convenient, and consumer oriented treatment system for treating nails and / or skin surfaces for a wide range of medical problems is completed. The treatment system of the present invention has wide applicability to a wide range of medical conditions, including many diseases, disorders, and medical problems, all of which can be treated using the present invention. In particular, diseases, diseases and medical conditions, including but not limited to psoriasis, skin cancer, warts, leishmaniasis, mycobacteria, and proto granulomas, particularly in the efficacy of the present invention and when they are applied It may be treated or ameliorated due to heat transmission efficacy.

Description

Therapeutic film-forming compositions and treatment systems {THERAPEUTIC FILM FORMING COMPOSITION AND TREATMENT SYSTEM}

Technical Field

FIELD OF THE INVENTION The present invention relates to nails and under nails, toenails and toenails, and to diseases occurring on the skin surface, and more particularly, to a fully integrated treatment system for applying drug treatment to diseases involving the nails and skin surface.

Background

Diseases that involve the skin surface, nails, and / or toenails of an individual are very common and often cause significant difficulties in the diseased individual. As described in detail herein, a wide range of diseases develop in individuals in this manner, and there appears to be no practically effective treatment.

It is important to understand the unique structure of nails in order to recognize the difficulties present in the art. As is well known, the nail is a unique keratinizable appendage produced by the embryogenic epithelium of the substrate. The structure of a typical nail is similar to that of the skin surface where the basal epidermal cells produce the stratum corneum. However, nails have harder keratin than skin because of the high concentration of sulfur matrix proteins.

Nails continue to grow without resting steps by adding neoplastic cells from the stroma. The epithelial component of the nail unit has a proximal nail fold that has a mitotic activity in which the granular layer is active and that is similar to or somewhat hypercellular proliferative of the skin. The keratin end product is a cuticle. The substrate has no granular layer with very inert mitotic activity and is hypercellular proliferative. The keratin end product is a nail plate. The nail base is free of granule layers with very inert mitotic activity and is very flat but only some keratinocytes are added to the underside of the nail plate as the nail plate moves to the end. Finally, the hyponychium is mitotic activity in which the granular layer is active, hyperproliferative, and only a few keratinocytes are added distal to the underside of the nail plate, similar to a cuticle.

Extensive problems can occur in the nails themselves or under the nail surface in treating nail and nail disease. To fully understand the importance of these issues, the following table lists representative examples of various diseases, disorders and medical problems that can be experienced and require effective treatment.

Skin diseases that can get on your nails Psoriasis / Pulmonary Psoriasis Flat line Idiopathic atrophy of the nail Glossy Tissue Line Zen ship Inflammatory gland warts epidermal nevus Alopecia areata Forenail dystrophy (Trachyonychia) Nail Eruption Eczema Nail Implications Hanpo Purulent dyskeratosis Vulgaris Suseongseong Yucheonpochang Acquired bullous epidermal detachment Fingernail Implications Polymorphic Erythema Drier's disease Pore red nasal cavity Plantar keratosis Bazex Syndryome

Nail Involvement During Systemic Disease Nail dissection, the third most common nail disease in skin disease after nail fungus and warts Chromonychia Bleeding condition Nail Loss (Full Nail Dissection or Spontaneous Nail Removal) Nail Softening (Soft Nails) Fingernail Rubbing (senile, old nails) Forenail dystrophy (Trachyonychia)

Nail tumors Epithelial tumor Benign claw sulcus cysts (epidermal inclusions) Onicoma tricoma melanin cellular tumor glomerular tumor mucus cyst septic granulomas Malignant Bowen's disease / squamous cell carcinoma Skin carcinoma Benign fibroid vascular tumor glomerular neoplasia granuloma gland hemorrhage Subtoenail tumor Subnail to exoskeleton Pigmented tumor Hypomelanosis / hypermelanin pigmentation / melanoma Infectious diseases Fungal Infections (Skin Fungi, Yeast, Deep Fungi) (Nail periarthritis)

Congenital keratinization disease Bottle on Leg (Darier-White Bottle) Hypomania Nail dysplasia Bullous epidermal detachment Forenail dystrophy Pore red nasal cavity Pansan Children's Boat Epidermal keratosis Hallucinosis Plantar keratosis Periodic peeling of the nail Ectoderm dysplasia Rothmund-Thompson Syndrome Congenital keratosis Enteropathic dermatitis Goldtz 'Syndrome Kid Syndrome

Nail Deformation / Illness Associated with Aging transform decolorization Appearance / Form Surface deformity Thickening Linear proliferation reduction disease Shred Claw Nail Dystrophy-Exogenous Enlarged nail Onychoclavus (corn under nail) Nail Endopathy (Endogenous Nails) Toenails Glandular bleeding Nail dysplasia Nail infections

One area in which individuals have proven very difficult to find effective treatments is psoriasis, particularly psoriasis associated with nails or toenails. In the United States, psoriasis is more than 6.4 million, which means that about 2% to 3% of all Americans have psoriasis. According to the National Psoriasis Foundation, approximately 200,000 new cases are diagnosed each year, with annual costs of about $ 1.6 billion to $ 3.2 billion in total outpatient costs. In addition, an estimated 56 million hours of labor are lost each year by psoriasis patients.

Nail psoriasis is very common and is known to account for up to 50% of all patients. It appears to develop more nails than toenails, which presents additional problems because the patient is more susceptible to nail changes that the patient can easily see. As a result, nail psoriasis disease affects both physically and mentally.

Clinical signs of nail psoriasis depend on the anatomical site of the nail unit involved. The bonds are very diverse and include the depression, bleaching, thickening, and nail exfoliation (separation from the nail bottom) of one or more nails. The effect of nail exfoliation may also involve underlying undergrowth growth, similar to nail fungus. Other changes commonly found include nail plate dystrophy, Mee's line (cross white line on nail plate), and Muehhrcke's line (cross section due to abnormal tubular pattern on the nail base seen through the nail plate. White line), exfoliation from the nail plate, Beau's line (typically the transverse folds of the nail plate due to intermittent matrix psoriasis), bleeding on the nail line, and sub-nail hyperkeratosis.

The purpose of treating nail psoriasis disease is to improve the physical and social psychological weakness associated with nail dystrophies. Unfortunately, current therapies do not cure nail psoriasis. Despite the many attempts and treatment modalities in the prior art, there is no specific, lastingly effective treatment for toenail psoriasis.

Many methods have been used, including topical, intralesional, and systemic methods, radiation therapy, and the like. However, most of these conventional therapies have significant risks and complications, including systemic toxicity, complications after radiation treatment, atrophy of the surrounding skin, pain, and the like. In addition, nail lacquers have been proposed in the past in various formulations for application to nails to treat psoriasis as well as many other nail diseases. However, these conventional nail lacquers have also been proven to be ineffective in treating the nail disease they desire. As a result, the need for a safe and effective treatment system for nail and nail disease has been going on for a long time, and there has been no satisfactory proposal until the present invention is presented which is easy to use, safe and cost effective.

Accordingly, a primary object of the present invention is to provide a rapidly drying film incorporating a desired therapeutic agent for treating a variety of medical problems, thereby providing on the desired surface of a human, including the nail surface and the skin surface. To provide a treatment system for humans that can be conveniently and easily applied to.

Another object of the present invention is to apply a thermal gradient to further enhance delivery of the therapeutic agent and to provide a very effective treatment system having the above-mentioned features.

It is another object of the present invention to provide a highly effective treatment system having the above-described characteristics that can be easily and effectively applied to treat a wide range of medical conditions.

It is another object of the present invention to provide a very effective treatment system having the above-described characteristics incorporating holding and supporting members fabricated with or interacting with the film forming composition and heat generating members for ensuring ease of application and use. will be.

Some of the other more specific purposes will be apparent and some will be described later.

Detailed description of the invention

By applying the present invention, all the difficulties and shortcomings found in conventional compositions, systems, methods and processes have been eliminated, and nails have a wide range of medical problems where topical, easily applied, convenient and consumer-oriented treatment systems have. And / or to treat the skin surface. In the present invention, the treatment system is intended for application to nails and / or skin surfaces, which may be applied in combination with, or independently applied to, an easily applied holding or support member for transferring heat directly to the application site, if desired. One or more therapeutic ingredients are incorporated.

The treatment system of the present invention has wide applicability for a wide range of medical conditions. In particular, many of the diseases, disorders, and medical problems detailed above can all be treated using the present invention. In particular, diseases, disorders and medical conditions, including but not limited to psoriasis, skin cancer, warts, rishmaniasis, mycobacteria, and proto granulomas, are effective in treating these diseases when the present invention and the present invention are applied. It may be specifically treated or improved because of its heat permeability.

In this regard, it is established that the application of heat inhibits or reverses metabolic processes, immune processes, or biological conditions or processes that are dependent on or affected by heat. As a result, many medical conditions are effectively treated by applying the therapeutic or drug containing film forming compositions described herein above with a heating source in accordance with embodiments of the invention comprising an integrated treatment system.

It has also been found that the use of heat produces a positive synergistic effect on the targeted and controlled delivery of a predetermined amount of drug and / or permeation enhancer. In this regard, topical use of drugs and / or penetration enhancers for the treatment of nail diseases, disorders, and medical conditions, and / or skin and subcutaneous surfaces, as fully detailed above, may be ameliorated by the use of the present invention or It is effectively treated. In addition, the delivery of drugs and / or penetration enhancers to the nails or through the nail to tissues under the nail for the purpose of parenteral and / or oral, systemic, transdermal delivery is effective alone and is also a thermal gradient. Is enhanced by the presence of regulation.

In general, the treatment system of the present invention is detailed below with respect to nails and their application to underlying tissues associated with nails. However, the present invention equally applies to diseases, disorders, and medical problems found on the skin surface that are not associated with nails. As a result, it will be understood that the present invention and the disclosure herein apply equally to any skin surface. As a result, the detailed use and application of the nail is presented for illustrative purposes only and consequently is intended to include the application and use of both the nail and the skin surface.

One major component of the present invention is a film forming composition that is specifically formulated to deliver one or more therapeutic ingredients to the site to which it is applied. The film forming site can be used specifically for nails to treat any desired nail disease while being used on any surface of the human body.

In addition to including one or more therapeutic ingredients, the film forming compositions of the present invention preferably comprise film formers, plasticizers, and ureas, all of which are in volatile carriers. Referring to Table I, the formulation range for each component is very clear. In this table, both the ranges that can be used and the preferred ranges are given.

ingredient Full range (% w / v) Preferred range (% w / v) Film former 0.5-25 5-10 Plasticizer 0.5-25 1-5 Urea 0.5-20 1-6 Therapeutic ingredients Effective amount required Effective amount required Solvent / volatile carrier 40-90 50-80

In forming the compositions of the present invention, any necessary film formers may be applied. However, in a preferred composition, the film former is a mixed polymer of polyvinyl acetate, vinyl acetate and acrylic acid, a mixed polymer of (meth) acrylic acid and (meth) acrylate ester, polyvinyl acetate, polyvinyl butyryl, One or more selected from the group consisting of polyvinyl alcohol, cellulose acetate phthalate, cellulose acetate butyrate, cellulose acetate propionate, cellulose nitrate, cellulose sulfate, ethylcellulose, and cellulose derivatives. In this respect, one preferred film former is ammonio methacrylate copolymer (II) sold under the trade name "Eudragit RL-100" by Rohm Pharma GmbH, Weiterstadt, Germany.

In addition, any desired plasticizer can be applied. However, in a preferred composition, the plasticizer composition comprises one or more selected from the group consisting of polyhydric alcohols such as triacetin, propylene glycol and butylene glycol, castor oil, camphor and phthalate. In this regard, one preferred plasticizer includes dibutyl phthalate sold under the trade name " Eastman DBT Plasticizer " of Eastman Chemicals.

In formulating the compositions of the present invention, any suitable solvent or volatile carrier may be applied. However, the solvent / volatile carrier is preferably alcohol (eg ethanol), ketone (eg acetone), ether (eg chloroform), aromatic hydrocarbons (eg toluene), esters (eg ethyl acetate) ), And one or more selected from the group consisting of water.

In selecting or formulating a combination of ingredients for a solvent / volatile carrier, the preferred compound or compounds are not only slow enough to allow complete application of the active ingredient to the nail or skin surface, but also different nail or skin surface. It has been found that when in contact with the surface it must act as a solvent for the carrier at a sufficiently high evaporation rate to prevent the composition from being removed.

One preferred formulation for the therapeutic film forming composition is detailed in Table II. In forming this preferred composition, a so-called Eudraight RL-100 film former is first dissolved in an acetone / ethanol / water carrier. After the clear solution is formed, the other ingredients are added and mixed in until completely dissolved. In addition, the desired therapeutic agent is also added and mixed with it to form the desired therapeutic film forming composition for application to the nail or skin.

ingredient amount Clobetasol Propionate 0.05% w / v Urea 3% w / v Dibutyl phthalate 1.5% w / v Eudragit RL-100 7% w / v ethanol 70% w / v water Sufficient to 100%

To complete the therapeutic film forming composition of the present invention, one or more therapeutic ingredients are incorporated into the composition in an amount sufficient to provide the desired effect. Generally, the therapeutic components applied are from the group consisting of corticosteroids, chemotherapeutic agents, anesthetics, antihistamines, antibacterial agents, antiparasitic agents, antiviral agents, antioxidants, tars, anthralines, immunomodulators, keratinants and antineoplastic agents. It includes one or more selected. Although a wide range of chemicals are within the scope of such agents, those listed below provide conventional compositions that are effectively applied as part of the treatment system of the present invention. However, these listings are for illustrative purposes and are not intended to limit the invention thereto.

In this regard, the corticosteroid may comprise one or more selected from the group consisting of hydrocortisone, triamcinolone, betamethasone, and any other steroid commonly used for topical application to the skin; The chemotherapeutic agent may comprise one or more selected from the group consisting of 5FU, bleomycin, methotrexate, and cytotoxic agents; Anesthetics may include one or more selected from the group consisting of lidocaine, prilocaine, and pramoxin; The antihistamine may comprise one or more selected from the group consisting of diphenhydramine and salts or doxepins thereof, and the antibacterial agent is one selected from the group consisting of gentamicin, tetracycline, erythromycin and clindamycin, anoxycillin It may include the above; The antiparasitic agent may comprise one or more selected from the group consisting of metronidazole, fermethrin, and crotamiton; The antiviral agent may comprise one or more selected from the group consisting of acyclovir and the antioxidant may comprise one or more selected from the group consisting of ascorbic acid and tocopherol; The immunomodulatory agent may comprise one or more selected from the group consisting of imiquimod and beta glucan; Keratinants may comprise one or more selected from the group consisting of salicylic acid; Antineoplastic agents may include one or more selected from the group consisting of cytotoxic agents and immunomodulators.

In addition, as described herein above, the use of thermal gradients, as provided by one of the most damaging embodiments of the present invention, is effective to allow the enhancer to be applied more effectively. In this regard, as described fully below, enhancers that particularly benefit from the use of one embodiment of the present invention include solvents, surfactants, ethers, esters, fatty acids, glycerides, ureas, oleates, liposomes, retinoids, and closures At least one selected from the group consisting of compounds.

As discussed above, the present invention independently includes the use of the therapeutic film forming composition in one embodiment, and also includes the use of a heat transfer member applied in combination with the therapeutic film forming composition. In using the present invention on nails and / or skin surfaces, the therapeutic film forming compositions are applied to nails and / or skin surfaces. Once the film layer is established, when applying this embodiment, a heat transfer member is positioned over the nail to provide a continuous thermal gradient directly to the diseased nail and / or skin surface.

As described above, the application of heat has been found to enhance the delivery and efficacy of many therapeutic ingredients. When applying this embodiment, heat transfer is preferably achieved by applying a heat transfer pad used in combination with the holding member. In a preferred construction, a heating pad or heat transfer patch is applied for heat supply. Exothermic pads or heat transfer patches have been developed in the past, and typically include porous films or pads of woven or nonwoven fabrics incorporating chemicals that exothermic to generate heat in the presence of oxygen. Although any desired chemicals may be applied, the exothermic pad or heat transfer patch typically contains a mixture of moxa or iron powder, activated gum, wood fibers, water and salts. Alternatively, a mixture of alkaline sulfides and iron carbides is applied with chemicals stored in an inert, oxygen free container to prevent exposure to oxygen prior to use. In addition, the holes in the pads are large enough to achieve the required air flow. If desired, any alternative heat generating pads, products, or constructs may be applied.

Prior to use, the patch / pad is typically formed from an inert gas such as nitrogen or sealed in an odorless pouch. As long as the patch / pad is kept in a sealed container until use, no chemical reaction occurs. However, once the pouch is opened, the chemical reacts due to the presence of oxygen in the air and the desired exothermic reaction occurs.

In embodiments of the present invention, the exothermic pad or heat transfer patch may be applied separately by placing the pad or patch in a desired position where heat treatment is required by the user. If desired, the heat transfer patch or heating pad is separated and fixed in the desired position by the adhesive means associated therewith.

Once the patch / pad is secured in the desired location, the holding member of the treatment system of the present invention is secured in the desired location to help regulate and control heat levels or air transfer to the heating pad or heat transfer patch, The heating pad or heating patch is wrapped around and held in place. In this way, the desired controlled heat transfer or heat gradient is realized, which allows a wide range of medical conditions to be effectively treated. In addition to providing controlled heat transfer for the direct treatment of a particular medical condition, the use of a thermal gradient as provided by this embodiment of the fully integrated treatment system of the present invention is a systemic and topical incorporation in a therapeutic film forming composition. It is effective to improve and enhance the penetration of the drug.

As is evident from the foregoing, a wide variety of medical conditions are treated effectively and efficiently using the treatment system of the present invention. As described above, one embodiment of the treatment system of the present invention is combined with a holding member that maintains a heat transfer patch or heating pad in exactly the desired location where a specific medical problem is encountered or heat transfer or heat gradient is desired. Heat transfer patches or heating pads. In addition, nail or skin penetration enhancers may be incorporated into the treatment system of the present invention for further enhancement of its efficacy.

One area where the use of heat is widely documented is the treatment of warts. In this regard, heat transfer to warts is fully disclosed in Dvoretzky, US Pat. No. 5,053,024. However, the use of heat to treat other skin diseases or medical conditions as well as the use of heat to aid in the delivery and / or absorption of medicaments and nail / skin permeation enhancers, in particular in combination with therapeutic film forming compositions, is generally known. It does not mean progress in these technical fields.

By applying this embodiment of the treatment system of the invention comprising a holding film and a therapeutic film forming composition combined with a heat transfer patch or a heating pad, the temperature of the nail or skin is raised to about 39 for about 1 to 10 hours. It is maintained at 45 to 45 ° C. In addition, by applying the present invention, the heat level at which the nail or skin is exposed is maintained in a narrow control range, which means optimal heat exposure for accurately delivering the desired agent and treating the medical condition. As a result, optimal performance and treatment are achieved.

According to the invention, the support member is specifically designed so that it can be quickly and easily fixed to a part of the body, such as a finger, surrounding the distal end of the engagement with the nail to be treated, and with the film forming composition and the heat transfer patch or heating pad. Maintain exactly the intended position, which is mutually related. In addition, the support members of the present invention are also specifically fabricated from materials designed specifically to cooperate synergistically with heat transfer patches or heating pads so that the exact required temperature level is maintained and the optimum oxygen flow is realized for exactly the desired time. do.

The support members forming the components of the holding system of the present invention are intended to provide a quick, easy and safe direct mounting fixation that is desired on any finger or toe, or any other part of the human body in need of treatment. It can be manufactured in various alternative structures. In this regard, one embodiment of the support system of the present invention consists of a continuous, substantially cylindrical tube member. By applying the cylindrical member, the holding system of the present invention allows the user's hand or foot to surround at the distal end of the nail to be treated, which holds and cooperates with the pre-mounted heating pad or heat transfer patch securely in the desired position. It can be easily mounted on.

One feature of the invention is the material applied to form the treatment system of the invention. In this regard, most woven or nonwoven fabrics can be applied to form the retaining member. However, it has been found that preferred materials include elastomers that are intact or formed therein to provide flexibility in the holding system being easily mounted or secured in place. In one preferred structure, the elastomer is formed integrally as part of a material, such as a thermoplastic elastomer. In this regard, preferred thermoplastics include foam thermoplastic elastomers selected from the group consisting of polyurethanes, polyolefins, polybutylenes, polyethylenes, polyesters, ethylene-propylene rubbers, polypropylene, silicone and vinyl based resins.

By applying foam thermoplastic elastomers, precisely the desired combination of closed and open cells is obtained in the ratio of closed and open cells in which the desired range is controlled within the desired range. In this way, the ability of the material to transfer directly from the ambient air to the location of the heat transfer patch or heating pad, as well as the heat retention and / or insulation capacity of the material, is precisely controlled.

According to an embodiment of the invention in which heat transfer is applied, the temperature transferred directly to the nail or skin surface by the heating pad or heat transfer patch is precisely controlled in a narrow range for a predetermined time due to the insulation provided by the holding system. In addition, oxygen is continuously circulated through the holding system to provide proper operation of the exothermic pad / patch as well as to provide air circulation to the nail or skin surface to be treated.

The above stated objects, which are particularly apparent from the preceding description, are achieved efficiently, and since all modifications may be made to the configurations set forth without departing from the scope of the present invention and carrying out the process in the desired product, It should be appreciated that they should be construed as illustrative and not restrictive.

In addition, the following claims are to be understood to include all descriptions of the scope of the invention which should belong to them because of the general and specific features and language of the invention described herein.

In particular, in the above claims, it is to be understood that the components or compounds described in the singular form include compatible mixtures of the components within the meaning permitted by the meaning.

The invention has been described and claimed as novel and intended to be protected by a patent registration is as follows:

Claims (29)

A. About 0.5 to 25% w / v film former based on the weight / volume of the total composition; B. about 0.5 to 25 weight / volume of plasticizer based on the weight / volume of the total composition; C. about 0.5 to 20 weight / volume urea based on the weight / volume of the total composition; D. about 40 to 90 weight / volume of solvent / volatile carrier based on weight / volume of the total composition; And E. Localized in humans for transdermal delivery of the desired therapeutic agent, including an effective amount of one or more therapeutic ingredients, which can be applied to any desired site of the individual to provide localized local treatment of a particular disease. Film forming therapeutic composition for topical application. The film forming agent of claim 1, wherein the film former is selected from polyvinyl acetate, mixed polymers of vinyl acetate and acrylic acid, mixed polymers of acrylic acid and acrylate ester, polyvinyl acetate, polyvinyl butyryl, polyvinyl alcohol, cellulose derivative, cellulose acetate phthalate, A therapeutic composition further defined as comprising one selected from the group consisting of cellulose acetate butyrate, cellulose acetate propionate, cellulose nitrate, cellulose sulfate, ethylcellulose and cellulose acetate. The therapeutic composition of claim 1, wherein the film former is further defined as comprising an ammonio methacrylate copolymer. The therapeutic composition of claim 1, wherein the plasticizer is further defined as comprising one or more selected from the group consisting of triacetin, polyhydric alcohol, propylene glycol, butylene glycol, castor oil, camphor, and phthalate. The therapeutic composition of claim 4, wherein the plasticizer is further defined as comprising dibutyl phthalate. The therapeutic composition of claim 1, wherein the solvent / volatile carrier comprises at least one selected from the group consisting of alcohol, ethanol, ketone, acetone ether, chloroform, aromatic hydrocarbon, toluene, ester, ethyl acetate and water. The method of claim 1 wherein the solvent / volatile carrier has an evaporation rate that allows the active ingredient of the composition to be applied completely to the skin surface and prevents the composition from being removed when the therapeutic surface is in contact with another surface. Therapeutic composition. 8. The therapeutic composition of claim 7, wherein the solvent / volatile carrier is further defined as comprising 50% / vol% acetone in admixture with 50% / vol% ethanol. The method of claim 1, wherein the therapeutic agent consists of a corticosteroid, a chemotherapeutic agent, an anesthetic, an antihistamine, an antibacterial agent, an antiparasitic agent, an antiviral agent, an antioxidant, a tar, anthraline, an immunomodulator, a keratinizing agent, and an antineoplastic agent. A therapeutic composition comprising one or more selected from the group. The method of claim 9, wherein the therapeutic agent is hydrocortisone, triamcinolone, betamethasone, 5FU, bleomycin, methotrexate, cytotoxic agent, lidocaine, prilocaine, diphenhydramine and salts thereof, doxepin, gentamicin, tetracycline, erythro Further comprising at least one selected from the group consisting of mycin, clindamycin, metronidazole, fermethrin, crotamito, acyclovir, ascorbic acid, tocopherol, imiquimod, beta glucan, salicylic acid, cytotoxic and immunomodulatory A therapeutic composition, characterized by the above. The therapeutic composition of claim 1, wherein the composition further comprises an enhancer for assisting delivery of the therapeutic component. 12. The therapeutic composition of claim 11, wherein the composition is further defined as comprising heat transfer means designed to make a top bond cooperative with the composition to provide a thermal gradient in the use and delivery of the therapeutic composition. 13. The therapeutic composition of claim 12, wherein the enhancer comprises at least one selected from the group consisting of solvents, surfactants, ethers, esters, fatty acid glycerides, ureas, oleates, liposomes, retinoids and closure compounds. A. 1. About 0.5 to 25% w / v film former, based on the weight / volume of the total composition; 2. from about 0.5 to 25 weight / volume of plasticizer based on the weight / volume of the total composition; 3. from about 0.5 to 20% w / v urea, based on the weight / volume of the total composition; 4. from about 40 to 90 weight / volume of solvent / volatile carrier based on the weight / volume of the total composition; And 5. film forming compositions comprising an effective amount of one or more therapeutic ingredients; B. a heat generating pad incorporating heat generating means incorporated therein and configured to transfer a desired amount of heat upon activation; And C. 1. cooperate with the heat generating pad to enable direct heat application to the desired application site of the film forming composition; 2. Providing the therapeutic agent and heat in any desired position in a precisely controlled manner, including holding and support members adapted to be fixedly retained to a portion of the human body in top engagement with the heat transfer patch / pad and film forming composition. A therapeutic system for transdermal delivery of a therapeutic agent for treating a wide range of medical conditions in humans, which can be fixed to any desired portion of the human body. 15. The treatment system of claim 14, wherein the holding member is configured to be secured to one body part selected from the group consisting of finger, arm, elbow, toe, foot, leg, wrist, ankle and upper body. 15. The treatment system of claim 14, wherein the holding and supporting member comprises a long, substantially planar component incorporating locking means for securing the member in any desired position. 17. The treatment system of claim 16, wherein the locking means is defined as comprising one selected from the group consisting of adhesive, hook, and loop fasteners. 15. The treatment system of claim 14, wherein the holding and support member is further defined as being formed of a thermoplastic elastic material. 19. The method of claim 18 wherein the thermoplastic elastomer is defined as comprising one selected from the group consisting of polyurethane, polyolefin, polybutylene, polyethylene, polyester, ethylene propylene rubber, polypropylene, silicone, and vinyl based resins. Treatment system. 18. The device of claim 17, wherein the locking means are attached to opposite surfaces of the holding and supporting member, paired with one another and cooperate with each other to securely hold the holding and supporting member in any desired position or position of the object. And a two or more cooperating interlocking members positioned to engage. 21. The method of claim 20, wherein a pair of cooperating interlocking members is mounted on the first surface of the holding and supporting member in a cooperative relationship with a first interlocking member spaced apart from and cooperative with a heat generating pad mounted to the holding and supporting member, The second interlocking hook and loop locking member is firmly secured substantially throughout the opposing surface of the holding and supporting member, so that the interlocking and locked interlocking engagement of the first interlocking member and the second interlocking member is quick and easy. A treatment system further defined as comprising hook and loop locking means held in substantially any desired position or location. 18. The mounting device of claim 17, wherein the mounting means is one of the holding and supporting member together with the heat generating pad such that the locking means can securely hold the holding and supporting member and the heat generating pad in any desired place or position of the individual's skin. And further defined as comprising an adhesive layer fixed to the surface of the substrate. 18. The method of claim 17, wherein the heat generating pad is further defined as being activated by exposure to oxygen and wherein the treatment system is packaged in an endless, openable oxygen free container, such that no single heat generating pad is used. And a delivery system stored in said openable container to enable reusable application for a short time. 15. The film forming agent of claim 14, wherein the film former is selected from the group consisting of polyvinyl acetate, mixed polymers of vinyl acetate and acrylic acid, mixed polymers of acrylic acid and acrylate esters, polyvinyl acetate, polyvinyl butyryl, polyvinyl alcohol, cellulose derivatives, cellulose acetate phthalate, And cellulose acetate butyrate, cellulose acetate propionate, cellulose nitrate, cellulose sulfate, ethylcellulose and cellulose acetate. 25. The therapeutic system of claim 24, wherein the plasticizer is further defined as comprising one or more selected from the group consisting of triacetin, polyhydric alcohol, propylene glycol, butylene glycol, castor oil, camphor, and phthalate. The therapeutic system of claim 25, wherein the solvent / volatile carrier comprises at least one selected from the group consisting of alcohol, ethanol, ketone, acetone, ether, chloroform, aromatic hydrocarbons, toluene, esters, ethyl acetate and water. 27. The method of claim 26, wherein the therapeutic agent is a corticosteroid, a chemotherapeutic agent, an anesthetic, an antihistamine, an anti-infective, an antifungal, an antibacterial, an antiparasitic, an antiviral, an antioxidant, a tar, anthraline, an immunomodulator, a keratolytic agent. And at least one selected from the group consisting of anti-neoplastic agents. The therapeutic composition of claim 14, wherein the film forming composition further comprises an enhancer for assisting delivery of the therapeutic component. The therapeutic system of claim 28, wherein the enhancer comprises at least one selected from the group consisting of solvents, surfactants, ethers, esters, fatty acid glycerides, ureas, oleates, liposomes, retinoids and closed compounds.