WO2008050491A1 - Préparation de film servant à former un film sur la peau - Google Patents

Préparation de film servant à former un film sur la peau Download PDF

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Publication number
WO2008050491A1
WO2008050491A1 PCT/JP2007/052923 JP2007052923W WO2008050491A1 WO 2008050491 A1 WO2008050491 A1 WO 2008050491A1 JP 2007052923 W JP2007052923 W JP 2007052923W WO 2008050491 A1 WO2008050491 A1 WO 2008050491A1
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Prior art keywords
film
skin
drug
forming
preparation
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PCT/JP2007/052923
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English (en)
Japanese (ja)
Inventor
Taiichirou Iwakura
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Japan Health Science Research Center.Ltd.
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Priority to JP2007550623A priority Critical patent/JP4836146B2/ja
Publication of WO2008050491A1 publication Critical patent/WO2008050491A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • Film formulation that forms a film on the skin
  • the present invention aims to form a film on the skin to seal the affected area, improve the transdermal absorbability of the contained drug to the affected area, enhance the local therapeutic effect, and further protect the affected area with a film. Therefore, the present invention relates to a film preparation that forms a film on the skin that prevents physical and chemical irritation of external force and bacterial infection, reduces the side effects, and reduces the side effects.
  • External therapy is a therapy intended to administer a drug percutaneously to cure the lesion, but has been developed as a treatment for skin lesions by administering the drug percutaneously.
  • DDS drug delivery system
  • the most important topical therapy is how percutaneously absorbed the drug applied to the skin surface can reach an effective concentration.
  • the three major factors that affect the percutaneous absorption of topical drugs are the properties of the drug, the type of external drug base that holds the drug, and the properties of the skin on which the drug is applied.
  • Healthy skin has a stratum corneum covered with a fat film (skin surface lipid) in the outermost layer of the skin, and the fat film and the stratum corneum prevent external substances from entering the skin. If the external medicine is used, it is an obstacle that reduces percutaneous absorption. In many skin disease lesions, this obstruction is often partially or completely removed, increasing the degree of percutaneous absorption of the drug. Therefore, more than expected drugs are absorbed through the skin, Side effects will be manifested, making it very difficult to determine the drug concentration in topical drugs. Therefore, many clinical trials are conducted to determine the appropriate concentration of topical drugs.
  • the bases are roughly classified into (1) ointment, (2) cream, (3) mud, (4) lotion, (5) plaster and tape, (6) spray, and (7) powder.
  • ointments, creams and lotions are generally used, and a surfactant is required to dissolve the drug in these bases.
  • preservatives such as paraaminobenzoic acid
  • these chemical substances are mildly irritating to the skin and have a significant effect on sensitive skin. .
  • the transdermal absorption of topical drugs is greatly influenced by the skin site and the skin properties of the site, and the skin of infants and the elderly has a thin epidermis layer and the stratum corneum is not sufficiently developed. Prone to increased absorption.
  • the percutaneous absorption of drugs is enhanced in areas where sweat easily accumulates such as the neck, heels, knees, elbows, and vulva.
  • topical use of steroids requires attention because the absorbed amount of the drug on the face, neck, and genital area is different from that of other parts.
  • the current external therapy is a therapy that administers the necessary concentration of drug to the skin lesion area to help cure the lesion, and can minimize the influence of the drug on the skin and other organs other than the lesion. It is an excellent treatment that can be performed while always observing changes in the lesion.
  • the topical therapy gives a slightly complicated feel to the procedure, from simple application of drugs to multi-layer therapy, sealing therapy, etc., especially in the case of a wide range of lesions, placing a great burden on the practitioner There is.
  • Patent Document 1 Japanese Patent Application No. 2005-136740
  • Patent Document 2 Japanese Patent Application No. 2005-198556
  • Patent Document 3 Japanese Patent Application No. 2005-254415
  • Ointments, cream jewels, and mud are semi-solid preparations that are pasty (paste), so it is difficult to apply a certain amount, and the effect depends on the application state (area 'amount) and application method (coating, rubbing frequency, etc.) It is easy to be affected.
  • the effects are particularly pronounced on damaged skin, and it is easy to influence the course of treatment after application.
  • soiling clothes, etc. after application and immediately wiping off the plaster with clothes, it is difficult to maintain a certain amount applied to demonstrate effectiveness.
  • the plaster is washed and washed away by washing the body such as bathing and showering, it is necessary to reapply it in order to maintain the drug effect in the affected area. There was a problem when bathing contaminated the hot water in the bathtub and inconvenienced those who took bath later.
  • Plasters, tapes, and poultices generally settle as adhesives, but often cause skin disorders such as rashes in the affected area to seal the affected area.
  • plaster and tape In addition to the skin irritation of the base itself, there is a risk that physical irritation at the time of peeling may lead to side effects such as rash, redness and itching in the affected area. Is expensive. In addition to skin disorders such as eczema, it has the disadvantage that it cannot be used on damaged skin. Furthermore, since the drug after use is almost in its original form, there is a problem that a great deal of cost is required for its processing and disposal.
  • the spray is a simple and non-staining preparation, but it is difficult to administer a certain amount of the drug because the drug diffuses in the form of a mist. For example, there is a risk of distribution to the lungs through the mucous membranes such as the eyes and mouth and the airways. In addition, since special filling containers are used, there is a cost to recover and dispose of the containers after use.
  • Products intended to protect the limbs have the functionality of protecting the limbs against physical irritation, but are uncomfortable to wear, causing odors and filth due to stuffiness and bacterial growth
  • early replacement and washing became a burden on the user.
  • the problem to be solved by the present invention is that formulations containing surfactants and preservatives (ointment, cream, etc.) are required in order to ensure the stabilization and guarantee of the quality of the formulation because water and oil are mixed in the formulation.
  • formulations containing surfactants and preservatives are required in order to ensure the stabilization and guarantee of the quality of the formulation because water and oil are mixed in the formulation.
  • jewels, plasters, and nops how should a film close to the skin tissue (especially the stratum corneum) be formed on the necessary skin? It is in that point.
  • the present inventor has considered a simple new formulation that has more effects, safety and convenience without degrading the properties and effects of external preparations and limb protection products.
  • a composition that takes advantage of the characteristics of conventional external preparations GEL, sprays, and patches (dosage forms before use, spray compositions, and dosage forms after use of patches) is used.
  • the new jelly formulation was applied to the skin, it was a semi-solid jelly before use, and after a thin coating on the skin, a film close to a thin patch was formed on the skin.
  • the present inventor has found that the film formed on the skin of the affected area functions to solve the above-mentioned problem, and arrives at the present invention. I was able to.
  • the film preparation according to the present invention solves the above-mentioned problems, and the invention of claim 1 relates to nitrocellulose in 3-methylbutyl acetate, isobutyl acetate, or acetone, or a mixture thereof. Dissolve, and add a drug with the main purpose of medicinal effect to a solubilizing agent to which ethyl alcohol is added, and form a transparent or translucent film on the skin at the application site to seal the affected area. It is a film preparation that forms a film on the skin.
  • the solvent is volatilized after application to the skin, and the affected part is sealed by forming on the skin of the affected part to which a transparent or translucent film is applied.
  • the drug applied to the affected area is covered with a film to prevent the outflow of the drug due to bathing or showering, so that the effect can be expected to be sustained, and it is different from infection to third parties via water. Eliminate peace.
  • it since it is non-aqueous, there is no need to use preservatives and surfactants that have a risk of adversely affecting the skin because the stability of the contained drug is high.
  • other auxiliary components may be blended with the above preparation.
  • the film preparation for forming a film on the skin of the present invention may be added with an appropriate amount of a water-soluble polymer such as polybulu alcohol or polybylpyrrolidone for the purpose of adjusting the friction coefficient or strength of the film. After being applied to the skin, the solvent is volatilized, and the affected area is sealed by forming a transparent or translucent film on the skin at the site of application.
  • a water-soluble polymer such as polybulu alcohol or polybylpyrrolidone
  • the ODT effect allows the contained drug to percutaneously pass through the affected area. Improves absorption (penetration), enhances local treatment effects, and protects the affected area with a film to prevent physical and chemical irritation of external forces and bacterial infections, and effects and side effects on the body including the skin Is reduced.
  • the film preparation for forming a film on the skin of the present invention may contain an external antibiotic as a drug in the solubilizing agent, whose main medicinal effect is to prevent infection of the affected area.
  • Antibiotics include gentamicin sulfate, fradiomycin sulfate, colistin sulfate, kuram lamfecole, chromai I, erythromycin, oxytetracycline hydrochloride, bacitracin, and sodium fusidate.
  • the film preparation for forming a film on the skin of the present invention contains a topical antifungal agent whose main medicinal properties are treatment of diseases caused by the growth of V, boil, bacilli and fungi as a drug in the solubilizer.
  • the antifungal agents for external use include: amorolfine hydrochloride, croconazole hydrochloride, terbinafine hydrochloride, neticonazole hydrochloride, butenafine hydrochloride, clotrimazole, ketocone, siccanin, isoconazole nitrate, econazole nitrate, oxyconazole nitrate, sulconazole nitrate , Miconazole, tolcyclate, tolnaphthalate, bifonazole, pimaricin, ranoconazole, and rilanaphthalate.
  • examples of the external antibacterial agent that may contain the external antibacterial agent include sulfadiazine, sulfadiazine silver, sulfisomidine, and nadifloxacin.
  • an enzyme having an action of dissolving blood coagulation and a melanin pigment of the skin are regenerated or deposited in a solubilizer.
  • Metoxalene which has the effect of returning to skin color, may contain keratosis treatment, and this keratosis treatment has etretinate, calcipotriol, tacalcitol, vitamin A, maxacalcitol, etc.
  • it may contain a keratolytic agent, and therefore it may contain an antiallergic external preparation that may contain urea or salicylic acid.
  • diphenhydramine acid which can be added to the external anti-inflammatory agents azulene, alcloxa, cephalanthin and zinc oxide.
  • diphenhydramine acid which can be added to the external anti-inflammatory agents azulene, alcloxa, cephalanthin and zinc oxide.
  • diphenhydramine acid which can be added to the external anti-inflammatory agents azulene, alcloxa, cephalanthin and zinc oxide.
  • diphenhydramine acid which can be added to the external anti-inflammatory agents azulene, alcloxa, cephalanthin and zinc oxide.
  • lysozyme chloride and bromelain vascularization 'granulation' bucladecin sodium which promotes skin formation, skin ulcer blood flow promotion and granulation 'alprosta' which promotes skin formation Gill alpha detas, tretinoin tocopheryl, iodine with long-lasting bactericidal and cleansing action, trafermin, a human basic fibroblast growth factor produced by genetic engineering, and a
  • a polyhydric alcohol alkanediol, erythritol, glycerin, xylitol, diglycerin, dipropylene glycol
  • a polyhydric alcohol alkanediol, erythritol, glycerin, xylitol, diglycerin, dipropylene glycol
  • moisturizing agent such as lecithin, soybean lecithin, egg yolk lecithin, chitin 'chitosan, etc.
  • the invention of claim 2 is a topical drug having a main medicinal effect of suppressing non-steroidal anti-inflammatory drug for external use as an anti-inflammatory agent or inflammation of an affected area as a drug dissolved in the dissolving agent of claim 1.
  • topical corticosteroids examples include amsinonide, prednisolone acetate valerate, dexamethasone valerate, betamethasone valerate, diflorazone acetate, hydrocortisone acetate, diflupredonate, betamethasone dipropionate, dexamethasone, triamcinolone acetate, halcinoide, Hydrocortisone, flumetasone pivalate, pudesodium, mometasone franconate, fluocinode, fluocinolone acetonide, fludroxycortide, predo-zolone, alcromethasone propionate, clobetasol propionate, dexamethasone propionate, Deprodon propionate, beclomethasone propionate, betamethasone, clobetasone butyrate, hydrocortisone butyrate, hydrocortisone butyrate propionate, There is
  • non-steroidal anti-inflammatory drugs for external use examples include indomethacin, ufenamate, dallicylretinic acid, ketoprofen, diclofenac sodium, suprofen, piroxicam, fuerbinac, bufuexamac, flurbiprofen, bendazac, methyl salicylate, salicylic acid There is.
  • the invention of claim 3 is a natural oil such as perilla oil, sesame oil, sesame oil, olive oil, horse oil, hinoki oil, castor oil as a drug dissolved in the solubilizer of claim 1.
  • a natural oil such as perilla oil, sesame oil, sesame oil, olive oil, horse oil, hinoki oil, castor oil as a drug dissolved in the solubilizer of claim 1.
  • the invention of claim 4 includes a polyhydric alcohol (alkanediol, erythritol, glycerin, xylitol, diglycerin, dipropylene glycol, 1,3-butylene glycolanol, propylene glycol, humectant as a humectant in the solubilizer of claim 1.
  • a polyhydric alcohol alkanediol, erythritol, glycerin, xylitol, diglycerin, dipropylene glycol, 1,3-butylene glycolanol, propylene glycol, humectant as a humectant in the solubilizer of claim 1.
  • Hexanediol, polyglycerin, D-mannitol, etc.) sericin, urea, uric acid, hyaluronic acid, hydrolysis collagen gel, DMAE (dimethylaminoethanol), lecithin, soybean lec
  • this moisturizing agent By containing this moisturizing agent, it also has an effect of keeping the moisturizing effect for a long time in combination with the sealing action of the film.
  • nitrocellulose is dissolved in a solubilizer of 3-methylbutyl acetate, isobutyl acetate, acetone, or a mixture thereof, and ethyl alcohol is further dissolved. Since various medicinal drugs were added to the added base in addition to anti-inflammatory drugs, the solvent evaporates after being applied to the skin, and a transparent or translucent film is placed on the skin (especially the stratum corneum).
  • it prevents the transfer of dirt and third parties due to the outflow of body fluid from the affected area and the diffusion of contaminants such as bacteria.
  • it is possible to prevent the occurrence of inflammation caused by smashing the affected part due to itching.
  • Even a base that does not contain a drug alone protects the skin itself and protects the skin from physical irritation by forming a film on the skin where the plaster is applied thinly. In other words, there is an effect that it can act as a second artificial stratum corneum.
  • FIG. 4 is a diagram of [Table 6] of the antipruritic test results of Example 2 and Comparative Examples 2 and 3 of the present invention.
  • a preferred example 1 having an anti-inflammatory action of a film preparation for forming a film on the skin of the present invention will be described.
  • the mixing ratio of this example is shown in the following [Table 1].
  • a film preparation for forming a film on the skin of Example 1 so as to achieve the above composition ratio is prepared by the following procedure. First, 5 to 10% by weight of nitrocellulose, preferably from 6.0% by weight, acetic acid 3 3-8 wt 0/0 methylbutyl, after preferably dissolved in 6.0 wt%, further, acetone 12-8 wt% Add 10.0% by weight, and stir well at a liquid temperature of 30 ° C. Next, 80-60% by weight of ethyl alcohol, preferably 72.9% by weight, was added to this solution and stirred well, and then indomethacin, crotamiton, 1 menthol, and sesame oil were added in small amounts while stirring. After stirring and kneading for an hour, the mixture is allowed to stand at room temperature for 24 hours for production.
  • the above-mentioned -trocellulose, 3-methylbutyl acetate, and acetone are film-forming materials
  • ethyl alcohol is a solvent that volatilizes. Ethyl alcohol volatilizes within 30 seconds to 1 minute after application, and a film is formed on the surface of the preparation.
  • 0.5% of indomethacin is added as a non-steroidal anti-inflammatory agent for external use whose main medicinal effect is to treat painful and swollen skin diseases and inflammation of muscle joints. If it is too much, side effects and cost will increase, so 1-0.2% by weight of indomethacin is a good solubilizing agent.
  • crotamiton as an antidepressant, preferably 0.5% by weight.
  • Strength with 1.0 as humectant for improvement 0.2-5.0 wt% is better, preferably 1.0-3.0 wt% is better 0.2 wt% Less effective than 5 wt% At most, sericin precipitates and does not dissolve.
  • Disinfectant '0.05 to 0.3% by weight of 1-menthol as a cooling agent preferably from 0.1 0/0, the strength of the film during film formation' Suruga added 3.0% by weight of sesame oil to enhance the flexibility and ODT effect, If it is too little, too much drug efficacy will inhibit film formation, so 1.0 to 10% by weight is good.
  • Example 1 The effects and effects of the bath film preparation for forming a film on the skin of Example 1 produced by the above composition and adjustment method were verified under the following conditions.
  • Control product Commercially available commercially available anti-inflammatory gel preparation containing indomethacin (hereinafter: Comparative Example 1) (B company indomethacin-containing gel preparation)
  • Example or Comparative Example was uniformly applied to the subject's waist 12 hours before bathing (1 hour after waking up). This action was conducted every day for 6 consecutive days.
  • the symptom was evaluated for the back pain according to the following criteria.
  • the degree of improvement in symptoms was determined according to the following criteria.
  • Example 1 was judged on the 7th day, and in judging the improvement of symptoms, there were 4 cases of marked improvement, 1 case of moderate improvement, and 5 cases of 5 cases. More than moderate improvement. In contrast, in Comparative Example 1, the degree of improvement in symptoms was 1 for moderate improvement and 4 for mild improvement. Further, in the determination of the feeling of use in Example 1, it was very preferable, but 4 examples were preferable, but 1 example was preferable, and 5 examples out of 5 were more than preferable. On the other hand, in the judgment of the feeling of use in Comparative Example 1, there were 2 cases that were bad, 1 case that was very bad, and 2 cases that were normal.
  • Example 1 There were no stains on the bath and hot water during bathing in Example 1, but there were 5 cases, and it was considered that there was no bath contamination due to the preparation. In contrast, in Comparative Example 1, there were 2 cases of bathing and hot water stains when taking a bath, and all 3 cases were answered very much.
  • the example product is superior to the comparative example product in all aspects of improvement of symptoms, feeling of use, and evaluation of bath stains when taking a bath.
  • Example 1 The effect on the blood flow of the film preparation for forming a film on the skin of Example 1 produced by the above composition and preparation method was verified under the following conditions.
  • Control product Ordinary commercially available anti-inflammatory analgesic indomethacin-containing diel formulation (hereinafter: Comparative Example 1) (B company indomethacin-containing gel formulation)
  • the probe After confirming that the subject was in a certain resting state, the probe was placed on the subject's right hip, and the maximum blood flow (PK), average blood flow (MN), and pulse were measured. Thereafter, a certain amount of a comparative product was uniformly applied to the right waist, and after 60 minutes, the shoulder was immersed in a 40 ° C bath for 10 minutes, and PK, MN and pulse of the left shoulder were measured again after 1 hour from the bath.
  • PK maximum blood flow
  • MN average blood flow
  • Comparative Example 1 had a maximum blood flow of 6.1, an average blood flow of 1.8, and a pulse of 61 (several Z minutes) before application.
  • the mean blood flow was 2.2 and the pulse was 61 (several Z minutes).
  • Comparative Example 1 By application and bathing in Comparative Example 1, a slight increase of about 40% (1.4 times) in the maximum blood flow and about 20% (1.2 times) in the average blood flow was observed, but there was almost no change in the pulse. o
  • the example product exhibits a synergistic effect of the bath and the preparation that is far more efficient with respect to blood flow than the comparative product.
  • Example 1 The test results are shown in [Table 4] in Fig. 3. As can be seen from this [Table 4], in Example 1, all five subjects responded that the underwear stain from the drug was not soiled during the 6-day test period. On the other hand, all of the five respondents answered that the comparative product was very dirty, including those who answered that it was very dirty. This trend was answered with almost the same response during the test period. From the above results, the product of the example did not contaminate the clothes (especially underwear) compared to the product of the comparative example, which gave a good impression to the subject, and this was reflected in the persistence of the treatment and its therapeutic effect. It was thought to be an important factor.
  • Example 2 of the present invention will be described.
  • Example 2 the blending ratio of Example 2 is shown in the following [Table 5].
  • the film preparation for forming a film on the skin of Example 2 is prepared by the following procedure so as to achieve the above composition ratio.
  • Diphenhydramine, 1 menthol, dl-camphor, glycyrrhetinic acid, and castor oil are added in small portions with stirring, and the final ingredients are added and stirred for 3 hours. Then, leave it at room temperature for 24 hours for manufacturing.
  • -trocellulose, polybutyl alcohol, isobutyl acetate, and acetone are the film-forming materials.
  • Ethyl alcohol is a volatile solvent, and the ethyl alcohol volatilizes within 30 seconds to 1 minute after application. So that a film is formed.
  • a bactericidal disinfectant 'cooling agent 1 1.0 to 5.0% by weight of menthol, preferably 3.0% by weight, 1.0% dl camphor added as an antidepressant 0.5 to L: 0.0% by weight, preferably 1.0 to 5% by weight Glycyrrhetinic acid 0.5-3.0% by weight as an anti-inflammatory agent, preferably 1.0% by weight, Chitin 'chitosan 1.0 as a moisturizing agent to improve skin moisturizing after film formation 0.2 to 3% by weight 1.0% by weight of castor oil is added to increase the film's strength and flexibility and ODT effect. However, if the amount is too small, the film formation will be inhibited if there is too much medicinal effect. 0.5-10% by weight is good.
  • Example 2 The action and effect of the antipruritic film preparation for forming a film on the skin of Example 2 produced by the above composition and preparation method were verified under the following conditions.
  • Control product A commercially available itching-preventing ointment (Diphenhydramine manufactured by Company D,
  • Comparative Example 2 1 Ointment formulation containing menthol, dl-camphor, etc .: hereinafter referred to as Comparative Example 2)
  • One captured white mosquito was placed in a transparent polyethylene bag (30cm x 50cm), inflated with air, and the subject's right hand was placed in the bag. After confirming that the mosquito has stabbed a part of the hand, apply the product of the example, the time until itching disappears and the force disappears The disappearance time of edema that occurred was measured. Further, the degree of redness after 1 hour was deliberately lightly sprinkled 10 times intentionally and evaluated according to the following evaluation criteria.
  • the degree of skin damage at the same time was recorded according to the following criteria.
  • Example 2 itching disappeared in 43 seconds on average after drug application, and edema was 13.7 minutes, whereas in Comparative Example 2, it took 156 seconds on average to disappear, and 31.3 minutes to eliminate edema. Power ⁇
  • Comparative Example 2 it took about 3.6 times longer for itch disappearance and 2.3 times longer for edema disappearance than Example 2.
  • the itch disappearance time averaged 328 seconds and the edema disappearance time was 86.7 minutes.
  • the skin reaction 1 hour after deliberately hitting the affected area was 1 case of strong redness and 2 cases of slightly strong redness in 3 cases without treatment.
  • Comparative Example 2 there were 2 cases of strong V redness and 1 case that could not be judged! / ⁇ , but in Example 2, there was no reaction except for 1 case that could not be judged.
  • Example 2 can be a useful preparation more than conventional Comparative Example 2.
  • Example 2 in order to seal the affected area without any burden, skin damage such as rash of the affected area was observed. It is possible to maintain a certain amount of the coating to demonstrate the effectiveness that the plaster that does not come off can be wiped off with clothes, etc., and the medicinal effect acts reliably.
  • the examples of the film preparation for forming a film on the skin of the present invention improve the transdermal absorbability of the contained drug to the affected area, enhance the local therapeutic effect, and further protect the affected area with a film. It prevents physical and chemical irritation of external forces and bacterial infection, and after application to the skin, the solvent is volatilized and formed on the skin of the affected area where a transparent or translucent film is applied. The skin is sealed, the percutaneous absorption of the drug is increased, and the medicinal effect of the affected area is improved by preventing direct contact between the affected area and water, and at the same time, side effects (rash, redness, blistering, etc.) of the affected area are prevented.
  • Example 1 the drug applied to the affected area is covered with a film to prevent the outflow of the drug by bathing or showering, and the effect can be expected to be sustained. Eliminate infection and discomfort to the elderly. In addition, since it is non-aqueous, there is no need to use a preservative or surfactant that has a risk of adversely affecting the skin because the stability of the contained drug is high. Further, as in Example 2, it is extremely effective against stagnation, and itch disappears immediately.
  • the role of the stratum corneum of the skin protection against external physical chemical attack
  • sweat control and disinfection with base ingredients such as ethyl alcohol
  • base ingredients such as ethyl alcohol

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Abstract

L'invention concerne une préparation de film servant à former un film sur la peau, avec laquelle on forme sur la peau à traiter un film similaire au tissu de la peau placé sur un médicament et par laquelle on améliore l'absorption percutanée dans une zone affectée du médicament contenu dans la préparation, on accroît l'effet thérapeutique local et, de plus, on prévient la stimulation physique ou chimique externe ou l'infection bactérienne grâce à la protection par le film de la zone affectée. La préparation de film servant à former un film sur la peau est obtenue : en ajoutant un médicament principalement utilisé pour son efficacité à un solvant obtenu en dissolvant de la nitrocellulose dans de l'acétate de 3-méthylbutyle, de l'acétate d'isobutyle ou de l'acétone ou dans un mélange de ceux-ci et en y ajoutant en outre de l'alcool éthylique ; et en appliquant le mélange résultant sur la peau, ce par quoi on forme un film transparent ou translucide sur celle-ci de façon à isoler hermétiquement une zone affectée.
PCT/JP2007/052923 2006-10-24 2007-02-19 Préparation de film servant à former un film sur la peau WO2008050491A1 (fr)

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JP2007550623A JP4836146B2 (ja) 2006-10-24 2007-02-19 皮膚上にフィルムを形成するフィルム製剤

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JP2006-289047 2006-10-24
JP2006289047 2006-10-24

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WO2008050491A1 true WO2008050491A1 (fr) 2008-05-02

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PCT/JP2007/052923 WO2008050491A1 (fr) 2006-10-24 2007-02-19 Préparation de film servant à former un film sur la peau

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JP2010235471A (ja) * 2009-03-30 2010-10-21 Nippon Kenko Kagaku Kenkyu Center:Kk 被膜形成型製剤
JP2013507367A (ja) * 2009-10-08 2013-03-04 エムエスデー・コンシユーマー・ケア・インコーポレイテツド 低エーテル組成物およびデリバリー装置
WO2014104149A1 (fr) * 2012-12-28 2014-07-03 大正製薬株式会社 Préparation pour application sur la peau
WO2017159852A1 (fr) * 2016-03-18 2017-09-21 小林製薬株式会社 Préparation externe permettant de réduire les frottements sur la peau
WO2019176124A1 (fr) * 2018-03-13 2019-09-19 有限会社 日本健康科学研究センター Agent formant un revêtement imperméable à l'eau
CN115715819A (zh) * 2022-12-02 2023-02-28 青岛熙盛医疗科技有限公司 高透气性的医用创可胶及其制备方法和应用

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JPH0558914A (ja) * 1991-08-27 1993-03-09 Shiseido Co Ltd 皮膚外用剤
JPH0797317A (ja) * 1993-09-29 1995-04-11 Showa Denko Kk 被膜形成型外用剤
JP2003514835A (ja) * 1999-11-17 2003-04-22 ディ・エスジー・ライセンシング・コーポレイション 瘢痕を治療する方法と組成物
JP2003532668A (ja) * 2000-05-12 2003-11-05 サノフィ−サンテラボ 抗炎症剤の経皮投与用医薬組成物
WO2002100384A1 (fr) * 2001-06-12 2002-12-19 Hisamitsu Pharmaceutical Co., Inc. Timbre de type feuille
JP2003073263A (ja) * 2001-08-29 2003-03-12 Kosumedei:Kk 安定性が改良された貼付剤
JP2004123633A (ja) * 2002-10-03 2004-04-22 Medorekkusu:Kk 外用製剤
JP2005281167A (ja) * 2004-03-29 2005-10-13 Air Water Sol Kk エアゾール組成物及びエアゾール型外用剤
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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010235471A (ja) * 2009-03-30 2010-10-21 Nippon Kenko Kagaku Kenkyu Center:Kk 被膜形成型製剤
JP2013507367A (ja) * 2009-10-08 2013-03-04 エムエスデー・コンシユーマー・ケア・インコーポレイテツド 低エーテル組成物およびデリバリー装置
WO2014104149A1 (fr) * 2012-12-28 2014-07-03 大正製薬株式会社 Préparation pour application sur la peau
JPWO2014104149A1 (ja) * 2012-12-28 2017-01-12 大正製薬株式会社 皮膚適用製剤
WO2017159852A1 (fr) * 2016-03-18 2017-09-21 小林製薬株式会社 Préparation externe permettant de réduire les frottements sur la peau
WO2019176124A1 (fr) * 2018-03-13 2019-09-19 有限会社 日本健康科学研究センター Agent formant un revêtement imperméable à l'eau
JP2019156763A (ja) * 2018-03-13 2019-09-19 有限会社日本健康科学研究センター 耐水性被膜製剤
CN115715819A (zh) * 2022-12-02 2023-02-28 青岛熙盛医疗科技有限公司 高透气性的医用创可胶及其制备方法和应用
CN115715819B (zh) * 2022-12-02 2024-01-30 青岛熙盛医疗科技有限公司 透气性的医用创可胶及其制备方法和应用

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