JPS62153214A - Pharmaceutical preparation - Google Patents

Abstract

PURPOSE:To obtain a pharmaceutical preparation for applying to skin, exhibiting excellent drug releasability over a long period and having high stability, by laminating a drug-containing layer between an impermeable backing member and a crosslinked adhesive layer having pressure-sensitive adhesivity at normal temperature. CONSTITUTION:The objective pharmaceutical preparation 1 for skin application is a laminate composed of a drug-containing layer 2 inserted between an impermeable backing member 3 and a pressure-sensitive adhesive layer 4 or, further, between a substrate 5. Since the drug-containing layer of the present preparation is liquid or gel, it has low viscosity and constantly releases the drug over a long period. The drug content can be increased compared with a composition obtained by dissolving or dispersing a drug in a pressure-sensitive adhesive layer. There occurs little plastication of the pressure-sensitive adhesive layer and, accordingly, the preparation has high stability. The dissolved segment content in the pressure-sensitive adhesive layer 4 is 0.5-30 wt% and the drug- containing layer 2 is preferably supported by a supporting base 5 having through-holes with an opening ratio of >= 30% and a pore diameter of >= 50 mum.

Description

DETAILED DESCRIPTION OF THE INVENTION (a) Field of Industrial Application The present invention relates to a pharmaceutical preparation that has an increased drug content and allows the drug to be efficiently absorbed transdermally over a long period of time.

(b) Prior art In recent years, research and development of pharmaceutical preparations for transdermal absorption, such as gel preparations, tape preparations, and patch preparations, have been actively conducted.
Many attempts have been made to treat diseases using this technique, whether systemic or local.

Conventionally, this type of pharmaceutical preparation is of the type in which a transdermally absorbable drug is mainly contained in a polymeric substance to form a drug-containing layer, which is then applied to the skin.

(c) Problems to be solved by the invention However, in the above-mentioned pharmaceutical preparations, there is a limit to the amount of drug contained in the polymeric substance.In other words, it is difficult to increase the amount of drug contained in the adhesive. Over time, undissolved drug may reduce adhesive strength and adhesion to the skin, resulting in poor drug diffusion and a limit to drug release over a long period of time. In some cases, the desired absorption of drugs in the body and the therapeutic effects associated with drug absorption could not be expected.

For this reason, in the above-mentioned pharmaceutical preparations, only drugs with relatively low effective blood concentrations can be used, and the transdermal absorption efficiency of the drug may be low or inconsistent.

(d) Means for solving the problem of interstitial problems Therefore, as a result of intensive studies to solve the above-mentioned problems, the present inventors have found that the drug can be retained in a solution, dispersion, or gel state. This is the heading that led to the completion of the present invention.

That is, in the pharmaceutical preparation of the present invention, the drug-containing layer is interposed between an impermeable backing member and an adhesive layer that is adhesive at room temperature and crosslinked, and is encapsulated in a laminated manner. This is a characteristic feature.

The present invention will be explained in detail below.

The present invention is characterized in that the drug-containing layer uses one of a solution prepared by dissolving the drug in a solvent, a dispersion of the drug, or a gel formed from the drug.

The drug used in the present invention is not particularly limited as long as it is a physiologically active substance and has percutaneous absorption.

Examples of such drugs include those listed below.

b) Fluticosteroid M: For example, hydrocortiscin, prednisolone, beclomethasone probionate, flumethacin, triamcimerone, avian 7mushi/ronacetonide, 7ruocinolone, fluocinolone acetonide,
fluocinolone acetonide acetate, clobetasol propionate, etc.) Analgesic anti-inflammatory agents: e.g. acetamino-7-ene, mefenamic acid, flufenamic acid, indomethacin, diclofenac, phthalo-7-enac natrichum, alcro-7-enac, oxy-7-emptasone, 7-22 LufPfn, iffuro7ene, flurbipro7ene, salicylic acid, methyl salicylate,! -Menthol, Kan7A, Slingtsuk, Tolmetin Sodium, Naproxen, 7Emp7
c) Hypnotic sedatives: e.g. fuemebarbital, amobarbital, cyfrobarbicur, triazolam, nitrazepam, lorazepam, haloperidol, etc.; b) Tranquilizers: e.g. flu 7 enanone, teolitazine, noazepam, flunoazepam, flunitrazepam, etc. Haloperidol, chlorpromazine, etc. e) Antihypertensive agents: For example, clonidine, clonidine hydrochloride,
Pindolol, propranolol, propranolol hydrochloride, bucumolol, indenolol, nivanovin, nimodipine, lofenoxine, nidorenzpine, nipranolol, bucumolol, etc. f) Antihypertensive diuretics: e.g. hydrothiazide, bendroflunasai-7zide, cyclobenziazide, etc. g) Antibiotics Substances: e.g. penicillin, tetracycline,
Oxytetracycline, 7-radiomycin sulfate, erythromycin, chloramphenicol, etc.; 1) Anesthetic agents, such as docaine, nobucaine hydrochloride, pensicaine, ami-7-an QeWl-ethyl, etc.; , Nicecutin, acetosulfamine, clotrimazole, etc. n) Antifungal substances: e.g. pentamycin, amphotericin B1 pyrrolnidoline, tarotrimazole, etc. l) Vitamin preparations: e.g. vitamin A1 ergocalciferol, cholecalciferol, octothiazine , riboflavin butyrate, etc.) Anticancer drugs: e.g. nitrazepam, meprobamate, clonazepam, etc. c) Coronary vasodilators: e.g. nitroglycerin, nitroglycol, isosorbide dinitrate, erythritol tetranitrate, pentaerythritol tetra nitrate, propyl nitrate, diphenobine, etc.) Antihistamines: e.g. diphenhydramine hydrochloride,
Chlorpheniramine, di-7enyl imitasol, etc. ii) Antitussives: For example, dextromethorphan, dextromethorphan hydrobromide, terbutasone sulfate, 7-edrine, ephedrine hydrochloride, salbutamol, salbutamol sulfate, isoproterenolol, inhydrochloride broterenolol, inproterenolol sulfate, etc. 1) Sex hormones: e.g. propsterone, estradiol, etc. 2) Antibiotics: e.g. doxepin, 4) Cerebral circulation improving agents: e.g. nilgot alkaloids, iaenprodil, etc. ) Antiemetics, antiulcer agents: e.g. metoclopramide, clebopride, tonberitone, sufvoramine, sufvoramine hydrobromide, 5-fluorouracil, mercaptopurine, etc.) Biomedical drugs: e.g. polypeptide jJ (TRT (, L
HRH derivatives), prostaglandins, etc.; n) Others: Examples include 7-entanyl, digoxin, desmopressin, nohydroergotamine methanesulfonic acid, dihydroergotamine tartrate, etc. Two or more of these drugs may be used in combination as necessary. can do.

The content of the above drug is as follows with respect to the entire drug-containing layer:
It is preferably in the range of 0.5 to 40% by weight, and 0.5
If it is less than 40% by weight, the therapeutic effect will be poor;
Exceeding this limits the therapeutic effect and is economically disadvantageous.

In addition, examples of the solvent and dispersion medium used in the present invention include lower alcohols such as ethanol, ethylene glyfur,
Glycols such as triethylene glycol, polyethylene glycol, propylene glycol, dimethyl sulfoxide, trimethyl decyl phosphooxide, methyl octyl sulfoxide, trimethyl acetamide, dimethyl formamide, dimethyl sebacate, N-methyl-2-pyrrolidone, dimethyl lauryl amide, Examples of solvents and dispersion media include dodecylpyrrolidone, insorbitol, liquid paraffin, various surfactants, mineral oil, lanolin, ethyl acetate, toluene, chloroform, and pencil alcohol. Preferably, it also has the following functions.

Further, in the present invention, a gel agent may be used together with the above-mentioned solvent or dispersion medium, and the drug may be dissolved or dispersed in this mixture to form a drug-containing Wi (gel liquid layer).

Examples of the above-mentioned gel agents include water-soluble gel agents such as karaya gum, water-soluble proteins (e.g. gelatin), polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, sodium polyacrylate, hydroxyethyl poly(meth)acrylate, and water-insoluble gel agents. Examples include gel agents.

Further, in the present invention, an auxiliary agent that promotes transdermal absorption of the drug may be added to the drug-containing layer.

Examples of aids for promoting transdermal absorption of the above drugs include glycols (mainly for improving drug solubility) such as ethylene glycol, propylene glycol, polyethylene glycol, and polypropylene glycol, olive oil, squalene,
Oils and fats such as lanolin (mainly to improve drug diffusion), urea,
Urea derivatives such as allantoin (mainly to improve water retention in the stratum corneum), polar solvents such as trimethyldecyl phosphooxide, methyloctyl sulfoxide, dimethyl sulfoxide, trimethylformamide, dimethylacetamide, dimethyl laurylamide, dodecylpyrrolidone, and insorbitol ( Mainly improves keratin permeability), salicylic acid (mainly improves keratin softening property), amino acids (mainly improves keratin permeability), nicotinic acid benzyl ester (mainly for open pores), lauryl sulfate) 17um (mainly for skin) (changes the interfacial state of the skin), Salocol (used in combination with drugs with good transdermal absorption), etc. Other plasticizers such as diisopropyl heptanonate, heptatarate, noethyl sebacate, hydrocarbons such as liquid paraffin, various emulsifiers, ethoxylated stearyl alcohol, glycerin ester, isopropyl myristate, ethyl laurate, N-methylpyrrolidone etc. can be mentioned.

In addition, the backing member used in the present invention is essentially non-containing in order to prevent loss of drugs and solvents. There is no particular limitation as long as it is i-transparent, but examples include polyester, nylon, saran, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, ethylene-ethyl acrylate copolymer, A single film such as eye monomer (Surlyn), or thermoplastic and inert polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, ethylene-ethyl acrylate copolymer, etc. for polyester, nylon, saran, etc. Examples include films laminated with ionomers (Surlyn), etc., and films made by aluminum vapor deposition or printing on polyester, nylon, or Saran to improve aesthetic appearance and light-shielding properties.

Also, the thickness of this lining member is 20 to 300 μm.
It is preferable that

The pharmaceutical preparation of the present invention has a binding structure in which the drug-containing layer is interposed between the backing member and an adhesive layer that is adhesive at room temperature and is crosslinked and encapsulated in a laminated manner. .

The adhesive layer used in the present invention, which is adhesive at room temperature, is crosslinked and has a dissolved segment ratio of 0.5 to
It is important that the content is within the range of 1% by weight.6 If the dissolved segment ratio is less than 0.5% by weight, the drug release properties will deteriorate, while if it exceeds 30% by weight, the drug, drug solution, additives, etc. A problem arises in that the physical strength of the adhesive layer or the drug control function changes due to the pressure-sensitive adhesive layer. Therefore, by setting the dissolved segment ratio of the adhesive layer to 9.5 to 30% by weight, the strength of the adhesive layer is maintained, the drug release property is improved, and the stability of the formulation is improved. be.

The combination of the drug-containing layer and the adhesive layer is determined by the drug, solvent or dispersion medium used, and additives added as desired.

The above-mentioned adhesive layer is made of a substance that is adhesive at room temperature and whose main ingredient is rubber and/or synthetic resin, and a vulcanizing agent (if the main ingredient is rubber), a polyisocyanate compound, an organic peroxide, or a polyfunctional compound. Crosslinking may be carried out by blending a crosslinking component such as and heat-reacting it, or by irradiating the above-mentioned substance that is sticky at room temperature with an irradiation nose such as ultraviolet rays, electron beams, or radiation.Furthermore, metal crosslinking, Crosslinking may be achieved using various means such as plasma treatment crosslinking.

Substances based on rubber and/or synthetic resin that are sticky at room temperature include natural rubber, silicone rubber, styrene-isoprene-styrene block copolymer rubber,
A rubber adhesive consisting of a synthetic rubber such as isoprene rubber as a main ingredient and a tackifying resin, a softener, and a filler, and a polymer of (meth)acrylic acid ester or the ester and a functional moamer. Synthetic resin adhesives typified by poly(meth)acrylic adhesives or polyvinyl alkyl ether adhesives made of a copolymer of the following can be mentioned.

The above rubber-based adhesives (excluding silicone rubber-based adhesives) contain sulfur, sulfur-containing compounds, vulcanizing agents such as quinoxime, etc. (0.01 to 2 parts by weight per 100 parts by weight of the rubber component). Or a vulcanization component such as a vulcanization accelerator (0.01 to 3 parts by weight per 100 parts by weight of the rubber component) such as a thiazole type, thiourea type, thiuram type, dithiocarbamate type, etc. is blended, In addition, organic peroxide (0°0 per 100 parts by weight of the rubber component) is added to the silicone rubber system.
1-2ff11g) is blended.

Synthesis! ! The JIrrfr adhesive contains 0.01 to 1 part by weight of a crosslinking component such as a polyisocyanate compound, an organic peroxide, a polyfunctional compound, etc. per 100 parts by weight of the main component.

The adhesive containing the vulcanization or crosslinking component is applied to a thickness of 50 to 1000 μm (solid content) on the peeled body that has been subjected to release treatment, and a heating operation is applied to cause the vulcanization or crosslinking reaction. By this process, a crosslinked pressure-sensitive adhesive layer having the desired dissolved segment ratio can be obtained.

Therefore, the above-mentioned pressure-sensitive adhesive having tackiness at room temperature is subjected to vulcanization or f! Instead of blending the Aa component and heating and crosslinking, the adhesive is coated on the release body and then irradiated with a predetermined amount of irradiation such as ultraviolet rays, electron beams, and radiation.
It is also possible to form a crosslinked pressure-sensitive adhesive layer having a weight percent segmentation rate.

The above-mentioned dissolved segment ratio refers to a value obtained by immersing a sample of a crosslinked adhesive in toluene (temperature: 110° C.) for 30 minutes, then taking out the sample, and calculating using the following formula.

A preferred embodiment of the present invention includes a structure in which a porous support is provided on the drug-containing layer side, that is, on the inside of the adhesive layer.

With this configuration, the mechanical strength of the adhesive layer is further improved, and the handling of the pharmaceutical preparation can be made easier.

Examples of the support include polyester, nylon,
Examples include polyvinyl alcohol, polyacrylate, polyamide, cellophane, polyvinyl chloride, polyethylene, ethylene-polyvinyl alcohol copolymer, polyethylene-vinyl acetate copolymer, etc., but polyester film and Nylon film is preferred, and other supports such as textiles, nonwoven fabrics, and paper are also preferred.

Further, the thickness of the support is preferably 3 to 100 μto.

From the viewpoint of effective drug utilization, it is preferable that this support essentially has no drug adsorption properties.

In addition, in order to improve drug release properties, the above support contains:
It is desirable to provide through holes with a pore size of 30% or more and a pore diameter of 50 μm or more.

Further, the following method may be used to interpose and encapsulate the drug-containing layer between the backing member and the adhesive layer in a laminated manner.

(a) One side of the backing member is treated with silicone, the silicone-treated side of the backing member is overlapped with an adhesive layer, and the peripheral edge is heat-sealed and thermally cut into a predetermined shape.

Next, a drug solution, dispersion, or gel is injected into the heat-sealed area using an injection means such as a syringe.

(b) A drug-containing gel is laminated on the backing member, the gel is covered with an adhesive layer, and the peripheral edges of the backing member and the adhesive layer are pressed together.

The pharmaceutical formulation of the invention is thus obtained.

(e) Effect Since the pharmaceutical preparation of the present invention retains the drug in the form of a solution, dispersion, or gel, it is possible to improve the drug content compared to containing the drug in an adhesive. In addition, since the drug is held in a low-viscosity medium, the migration and diffusion of the drug is extremely good, resulting in excellent drug release properties.

Furthermore, since the pharmaceutical preparation of the present invention uses a specific cross-linked adhesive as its adhesive layer, the medium in the drug-containing layer does not ooze out, resulting in good tear stability. It has the effect of improving adhesion to the skin while controlling the release of □ to a suitable state.

(f) Examples ■Structural example of the pharmaceutical preparation of the present invention Next, the present invention will be specifically explained based on the drawings.

In FIG. 1, the pharmaceutical preparation (1) of the present invention includes a drug-containing layer (2), an impermeable backing member (3), and an adhesive layer (4) that is adhesive at room temperature and crosslinked. ) and is enclosed in a layered manner.

In a preferred embodiment of the present invention, as shown in FIG. 2, in the adhesive WI (4), a porous carrier (5
) to further improve the mechanical strength of the adhesive WUWI (4). In this case, the carrier (5) has a cleavage rate of 3 to improve drug release properties.
0% or more, and through holes with a hole diameter of 50 μm or more are provided.

Note that (6)... is a peeled body.

Next, the present invention will be explained in detail based on Examples, but the present invention is not limited thereto.

In addition, in the examples, parts or % mean 1 part by weight or % by weight.

Example 1 90 parts of 2-ethylhexyl acrylate and 10 parts of hydroxyethyl acrylate were placed in a flask under an inert gas atmosphere.
0.39% of azobisisobutyronitrile was added as a polymerization initiator, and polymerization was carried out while maintaining the temperature at about 60°C in a mixed solution of enal-toluene acetate (volume ratio 1:2). Acrylic adhesive solution (solid content 34.9%)
) was obtained.

This solution is adjusted to have a polymer content of 30%, and 0.3 parts of benzoyl peroxide, which is a crosslinking agent, is added and dissolved in 11 parts by weight of 100 parts of this polymer component.

The solution obtained by drying was applied onto a polyester peeling body with a thickness of 60 μm so that the thickness after drying would be 60 μm, and this was dried at a temperature of 150 to 160°C for 2 minutes, and then coated with benzoyl peroxide. A crosslinked adhesive layer (4) was obtained.

On the other hand, polyester (thickness 12
A silicone treatment was applied to the exposed surface of the ionomer in the backing member (3) using a laminate film of ionomer (15 μm thick).

Next, overlap the adhesive layer (4) with the adhesive layer (4) in the above-mentioned backing member (3) so that the outer diameter (L) is 4 am and the seal width (S) is 4 mL 1, as shown in figure fjS3. Heat seal (■]) and thermally cut.
This forms a flat disk, and a drug-containing solution consisting of 80% N-methylpyrrolidone and 20% 27dinopine, a coronary vasodilator, is injected into the inside of the disk using a syringe at 0.4 ml.
ml is injected, and the injection port is further heat-sealed, and the drug-containing layer (2) is bonded to the above-mentioned backing member (3) and adhesive layer (
A pharmaceutical preparation (1) of the present invention was obtained in which the pharmaceutical preparation (1) was interposed between the preparation and 4) and sealed in a layered manner.

Example 2 Using the acrylic adhesive solution of Example 1, a crosslinking agent consisting of trimethylolpropane (A) and tolylene diisocyanate (B) (compounding ratio of (A)) was prepared based on 100 parts by weight of the polymer component of this solution. (25no1%) based on the total of (A) and (B) is added and dissolved.

The solution thus obtained was applied onto a polyester release body with a thickness of 60 μm so that the thickness after drying would be 60 μm, and this was dried at a temperature of 30° C. for 12 hours to obtain an adhesive cross-linked with the above-mentioned cross-linking agent. Layer (4) was obtained.

Thereafter, a flat disk was formed in the same manner as in Example 1, and inside the disk, 15% chloroform and 7% liquid paraffin were added.
0.4 ml of a drug-containing liquid consisting of 5% and 10% Proplafol, an antihypertensive agent, was injected with a syringe, and the injection port was further heat-sealed to form the drug-containing layer (2) and the backing member (3). ) and adhesive M (4) and sealed in a layered manner to obtain a pharmaceutical preparation (1) of the present invention.

Example 3 In a flask under an inert gas atmosphere, 65 parts of 2-ethylhexyl acrylate, 25 parts of butyl acrylate, and 10 parts of carpitol 7 acrylate were charged, and 0.3 parts of azobisisobutyroni) was added as a polymerization initiator. 1 part and polymerized in toluene while maintaining the temperature at about 60°C to obtain an acrylic adhesive solution (solid content concentration 29.9%).

The obtained acrylic adhesive solution was applied onto a silicone-treated release paper so that y7.5 after drying was 30 μmn, dried at a temperature of 100°C for 4 minutes, and further coated with 5 Mrad from the adhesive side. An adhesive layer (4) was obtained by crosslinking by irradiating with an electron beam.

Next, a polyester film (pore size 90/j+o, In porosity 45%) having a thickness of 9 μIII was used as the support (5), and this was adhered to the adhesive layer (4).

On the other hand, a polyester (IF7, 12 μm + n)-ionomer (thickness: 20 μm) laminate film was used as the backing member (3), and the exposed surface of the ionomer in the backing member (3) was subjected to silicone treatment.

Next, the ionomer side of the above-mentioned backing member (3) and the support (5) side of the adhesive layer with support (4) are overlapped to form a flat disc in the same manner as in Example 1. A drug-containing solution consisting of 90% liquid paraffin and 10% nitroglycerin, a coronary vasodilator, was injected into the inner part of the tube using a syringe, and the injection port was further heat-sealed to form a drug-containing layer ( 2) was interposed between the backing member (3) and the adhesive layer (4) and encapsulated in a layered manner to obtain a pharmaceutical preparation (1) of the present invention.

Example 4 Using the acrylic adhesive solution of Example 3, 0.2 parts of benzoyl peroxide, which is a crosslinking agent, was added and dissolved in 100 parts of the polymer component of this solution, and the following procedure was carried out in the same manner as in Example 1. A crosslinked adhesive layer (4) was obtained.

Next, using a 50 μm thick nylon nonwoven fabric (pore diameter 110 μtas rfR porosity 35%) as the support (5),
This was attached to the pressure-sensitive adhesive layer (4).

On the other hand, polyester (thickness 12
A silicone treatment was applied to the exposed surface of the ionomer in the backing member (3) using a 20 μm thick ionomer laminate film.

Next, the ionomer side of the above-mentioned backing member (3) and the support (5) side of the adhesive with support/ff1 (4) are overlapped to form a flat disc in the same manner as in Example 1. 5% polyvinyl alcohol and 70% water inside the disc
A drug-containing gel solution consisting of 10% N-methylpyrrolidone and 15% 27-enovin, a coronary vasodilator, was injected with a syringe for 0.5 m, and the injection port was further heat-sealed to form a drug-containing layer ( 2), the backing member (3) and the adhesive F
A pharmaceutical formulation (1) of the invention was obtained, which was interposed between VI (4) and sealed in a layered manner.

Comparative Example 1 A sample was prepared in Example 1 without using the crosslinking agent (benzoyl peroxide).

Comparative Example 2 In Example 3, a sample was prepared in which the adhesive was not irradiated with an electron beam.

Comparative Example 3 Acrylic adhesive solution of Example 1 (solid content concentration 34.9
96), 40 parts of an N-methylpyrrolidone solution containing nianidipine (diphenopine content: 50%), which is a coronary vasodilator, is added to 100 parts of this polymer solid content and mixed uniformly. Then, it was applied onto a polyester release body having a thickness of 60 μm fi so that the thickness after drying would be 50 μm, and dried at a temperature of 110° C. for 4 minutes. Next, a 9μIff polyester film coated with aluminum was used to laminate the aluminum-coated side of the film and the adhesive side to obtain a pharmaceutical preparation.

A sample was prepared by punching out the pharmaceutical preparation thus obtained with a diameter of 32+nmφ.

The characteristics of each example and each comparative example are shown in Table 1 and FIG. 4.

(Margins below) Table 1 Note 1) Preparation Stability The samples of each Example and each Comparative Example were sealed in an aluminum packaging material, and after being left at a temperature of 30°C for one month, the drug-containing layer was The seepage of the medium (liquid) was visually evaluated.

The evaluation criteria in Table 1 are as follows.

◎: No seepage of medium ('a) at all.

O: There is very slight seepage of the medium (liquid).

Δ: There is some oozing of the medium (liquid).

×: The medium (liquid) seeped out significantly.

Rabbit patch test (highest blood concentration): Samples of each example and comparative example (diameter 4
c+++) on the back of the rabbit whose hair has been removed in advance 1
．． 3.5.8.12.24 and 48, respectively, 2 ml of blood was collected at each lapse of time, and the drug concentration in the blood was measured using a scchromatography or high performance liquid chromatography device.

The results are shown in FIG. 4, and the maximum blood concentrations are shown in Table 1.

From the results shown in the fjS4 diagram and the fjSi table, it is recognized that the pharmaceutical formulation of the present invention has excellent drug release properties over a long period of time and has good stability.

(8) Effects of the Invention The pharmaceutical preparation of the present invention has the above-mentioned structure and has a drug-containing layer in a liquid or gel state.Since the drug-containing layer is in a liquid or gel state, the viscosity is low; It has excellent drug release properties over a long period of time, and because it retains the drug in the form of a solution or dispersion, compared to dissolving or dispersing the drug in q/l before adhesion. This allows the drug content to be increased.

Furthermore, since the pharmaceutical preparation of the present invention uses a specific cross-linked adhesive as its adhesive, even if the liquid drug-containing layer and the adhesive layer come into contact, the adhesive layer hardly becomes plasticized, and as a result, The stability of the pharmaceutical formulation is good, and this unique adhesive layer has the effect of controlling drug release.

[Brief explanation of drawings]

Fig. 1 is an enlarged sectional view showing an embodiment of the present invention, Fig. 2 is an enlarged sectional view showing another embodiment, and Fig. 3 is a plan view thereof.
Figure S4 is a diagram showing changes in blood concentration of drugs over time. (1)...Pharmaceutical formulation, (2)...Drug-containing layer, (3
)...backing member, (4)...adhesive layer, (5)...
...Support, (6)...Peelable body.

Claims (6)

[Claims] (1) A pharmaceutical preparation comprising a drug-containing layer interposed between an impermeable backing member and a cross-linked adhesive layer that is adhesive at room temperature and encapsulated in a laminated form. (2) The pharmaceutical preparation according to claim 1, wherein the drug-containing layer is one selected from the group consisting of drug solutions, dispersions, and gels. (3) The adhesive layer has a dissolved segment ratio of 0.5 to 30
Pharmaceutical formulation according to claim 1 or 2, which is % by weight. (4) The pharmaceutical preparation according to any one of claims 1 to 3, wherein the adhesive layer has a porous support provided on the side of the drug-containing layer. (5) The support has a porosity of 30% or more and a pore diameter of 50 μm.
The pharmaceutical preparation according to claim 4, which has the above-mentioned through holes. (6) The pharmaceutical preparation according to claim 4 or 5, wherein the support is a woven or nonwoven fabric.