JP2019108299A - Plaster formulation and method for producing the same - Google Patents

Abstract

To provide patches that have a diameter changing toward the end of a longitudinal direction, can be stuck successfully when stuck on a roundish affected area, and are easy to release a plaster formulation from a release liner.SOLUTION: Provided is a plaster formulation comprising a plaster agent that comprises a plaster layer in which drug active ingredients are kneaded and a support coated on one face of the plaster layer, and a release liner to be stuck on the other face of the plaster layer of the plaster formulation, two substantially rectangular shaped plaster formulations being stuck on one release liner so that mutual short sides face each other at a predetermined distance, and each of the substantially rectangular plasters having a curved longitudinal side.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a plaster preparation for percutaneously absorbing a pharmaceutically effective ingredient such as, for example, a stiff neck drug, and further relates to a method for producing the plaster preparation.

  The patch to be attached to the skin includes a patch having a large water content of the base and capable of expecting a continuous cooling effect, and a plaster having a small water content of the base and not cooling the affected area. Similarly, although the poultice and the plaster are for percutaneously absorbing a pharmaceutically active ingredient that exerts effects such as anti-inflammatory and analgesic, it is selected according to the affected area to be attached. Specifically, the cataplasm is suitable for affected areas with less movement such as shoulders and hips because its adhesive performance is lower than that of a plaster, and its adhesive performance is higher than that of a cataplasm, so joints of movable parts It has been considered suitable for the affected area such as the surrounding area.

  However, the plaster agent is also effective in sticking to the vicinity of a joint or the like of a movable part because of its high adhesiveness, but there are cases where raw rubber (natural rubber latex) is used as an adhesive component. Raw gum contains a trace amount of protein, which may cause allergy to this protein. Therefore, since a styrene-isoprene-styrene block copolymer of a hot melt adhesive is used as an adhesive component without using a raw rubber, a favorable adhesive layer is formed without deterioration of the components of the hot melt adhesive, The proposal which consists of a paste which knead | mixed at the temperature of 50-100 degreeC is also performed (refer patent document 1).

Unexamined-Japanese-Patent No. 2004-277345

  As such a plaster preparation, it is particularly difficult to peel off the plaster agent from the release liner because the plaster agent having high adhesiveness and a thin plaster agent having the plaster layer attached to the release liner is thin and the release liner is also thin. Is a problem. In addition, when sticking to a rounded diseased part whose diameter is changing toward the end in the longitudinal direction, such as thighs, shins, arms, etc., it is easy to be wrinkled and easily peeled off from the generated wrinkles Also, there is a problem that the medicinal component of the eyelid part is not absorbed percutaneously and is not efficient.

  The present invention is a patch which can be stuck well when attached to a rounded diseased part whose diameter is changing toward the end in the longitudinal direction, and it is easy to peel off the plaster from the release liner. Another object of the present invention is to obtain a manufacturing method that is easy to manufacture this plaster formulation.

A plaster preparation according to the invention described in claim 1 is a plaster preparation comprising a plaster layer to which a medicinal ingredient is kneaded and a support coated on one surface of the plaster layer, and the plaster A plaster formulation comprising a release liner affixed to the other side of the plaster layer of the formulation,
The two substantially rectangular plasters are pasted on one release liner so as to face each other with a predetermined distance therebetween.
The individual substantially rectangular plasters are characterized in that the longitudinal sides are curved.

  The plaster preparation according to the invention described in claim 2 is characterized in that the plaster layer according to claim 1 is a plaster plaster layer in which a medicinal component is kneaded with a hot melt adhesive. .

  The plaster preparation according to the invention described in claim 3 is characterized in that it has a rounded rectangular shape in which four corners where the curved longitudinal side and the short side intersect according to claim 1 or 2 are rounded. It is said that.

The method for producing a plaster preparation according to the invention described in claim 4 is a plaster preparation comprising a plaster layer to which a medicinal ingredient has been kneaded and a support coated on one surface of the plaster layer. A method of producing a plaster formulation, comprising: a release liner applied on the other side of the plaster layer of the plaster formulation,
A plaster layer of plaster agent tape of the same width is pasted to a release liner tape having a width longer than the length of two long sides of a predetermined substantially rectangular plaster agent, and the plaster agent tape and the release liner A laminate forming step of obtaining a laminate;
A half-cut step of punching out a region of a central portion of the plaster agent tape from the obtained laminate, leaving the release liner;
A half-cut removal step to remove the central area of the punched plaster agent tape;
Release the plaster agent tape from the laminate after the half-cut removal step so that the two substantially rectangular plaster agents whose longitudinal sides are curved face each other with the short sides separated by a predetermined distance. And a cutting step of cutting at the same time.

  In the method for producing a plaster preparation according to the invention described in claim 5, in the laminate forming step according to claim 4, the release liner tape spreads a plaster layer obtained by kneading a medicinal component with a hot melt adhesive. After application, a support tape is attached to the plaster layer to obtain a laminate of plaster.

  In the method for producing a plaster preparation according to the invention described in claim 6, in the plaster preparation which has been subjected to the half-cutting step and the cutting step according to claim 4 or 5, the curved longitudinal side and the short side cross each other It is characterized in that it is punched and cut so as to be a round and substantially rectangular plaster with rounded corners.

  The present invention makes it possible to adhere well when sticking to a radiused diseased part whose diameter is changing toward the end in the longitudinal direction, and a plaster preparation which makes it easy to peel off the plaster from the release liner. The effect is that you can get Moreover, there is an effect that the manufacturing method which can manufacture this plaster formulation easily is obtained.

BRIEF DESCRIPTION OF THE DRAWINGS It is explanatory drawing which shows the structure of one Example of the plaster formulation of this invention, a figure is a top view, b figure is a side view, c figure is the front view containing a partially enlarged view. FIG. 2 is an explanatory view showing a manufacturing process of the plaster preparation shown in FIG. 1, wherein a is a step of forming a laminate, b is a step of half cutting a central region, and c is a step of removing a half cut region. (D) shows cutting of two plasters with release liner, (e) shows removing the punched sides, and (f) shows the plaster cut out as shown in FIG. It is explanatory drawing which shows manufacture of the plaster formulation shown in FIG. 1, and a figure shows the process to a laminated body formation process, b figure shows a half cut and a cutting process after that. FIG. 6 is an explanatory view showing another manufacturing process than the half cutting and cutting process shown in FIG. 3 b. It is a front view of the cutting drum used by the half cut shown in FIG. 3 or FIG. It is a front view of the cutting drum used by all the cuts shown in FIG. 3 or FIG.

  In the present invention, a plaster comprising a plaster layer to which a medicinal ingredient is kneaded and a support coated on one side of the plaster layer, and the other side of the plaster layer of this plaster preparation. A plaster preparation comprising a release liner to be attached to the top, wherein two substantially rectangular plaster agents are separated so as to face each other with a predetermined distance between the short sides of each other. The individual substantially rectangular plaster adhered to the liner is curved at its longitudinal side. Since the longitudinal side of the plaster to be attached is curved, it can be favorably attached to a rounded affected area whose diameter changes toward the end in the longitudinal direction. Also, one opposing side of two plasters can be easily flipped over on one release liner and can be easily peeled off from the release liner.

  Specifically, conventionally, since both the release liner and the plaster agent are thin, when trying to turn up the end of the plaster agent with a nail, the end side is rounded with a nail on the plaster layer side, and the adhesive surfaces stick to each other, There was a problem that it was difficult to peel off and it was not possible to cleanly attach to the affected area, but according to the present invention, one of the two plasters is made by moving the bent portion in the direction of the short side of the plaster while bending the release liner. The opposite sides can be easily flipped up, easily removed from the release liner, and can be cleanly attached to the affected area. Moreover, the plaster agent whose longitudinal side is curved is stuck without causing wrinkles by sticking to the affected area along the side of the rounded affected area whose diameter is changing toward the end in the longitudinal direction. Because it is worn, it does not come off easily even in the affected part such as the joint area of the movable part, and the medicinal component is also effectively administered.

  In the plaster preparation of the present invention, a plaster to be stuck to the affected area and a release liner attached to one side of the plaster layer of the plaster. Moreover, as a plaster agent, it is provided with the paste layer which the medicinal component was knead | mixed, and the support body adhered on the other surface of this paste layer.

  Each of the two substantially rectangular plasters of the present invention preferably includes a rounded substantially rectangular plaster rounded at four corners. As a result, the effect of being hard to peel off after sticking on the affected part is exhibited.

  As a method for producing a plaster preparation of the present invention, a release liner tape having a width longer than the total length of the long sides of the substantially rectangular plaster with at least two long sides curved is used. A laminate forming step of laminating a plaster layer of a plaster agent tape to obtain a laminate of a plaster agent and a release liner, and leaving the release liner in the region of the central portion of the plaster agent tape from the obtained laminate From the laminate after the half-cut step of punching out, the half-cut removing step of removing the area of the central part of the punched plaster agent tape, and the half-cut removing step, two substantially rectangular plaster agents are short sides of each other Cutting the plaster tape together with the release liner tape in a shape facing each other with a predetermined distance apart And, it is possible to manufacture.

  In addition, as the separated distance of the opposing short sides of the substantially rectangular plaster agent whose two longitudinal sides are curved, moving the bent portion in the direction of the short side of one plaster agent while bending the release liner. Therefore, it is only necessary to separate them so that the opposite sides of one of the two plasters can be easily turned over. Specifically, it may be about 1 mm to 10 mm. In addition, the curvature of the longitudinal side of the plaster may be a degree of curvature that does not cause wrinkles when it is attached to a rounded affected area whose diameter changes toward the end in the longitudinal direction.

  Preferably, the plaster agent which has been subjected to the half cutting step and the cutting step is punched and cut so that the plaster agent having rounded rounded rectangular corners and rounded rectangular corners is chamfered so that the four corners are rounded. A substantially rectangular plaster can be easily manufactured.

  As the plaster layer of the present invention, preferably, one obtained by kneading a medicinal component with a hot melt adhesive is mentioned. Specific examples of the hot melt pressure-sensitive adhesive include rubber-based pressure-sensitive adhesive substances. Examples of the rubber-based adhesive substance include diene-based polymer compounds conventionally used, specifically, natural rubber, synthetic rubber, and a mixture thereof. Examples of the synthetic rubber include styrene-isobutylene-styrene block copolymer rubber, styrene-butadiene rubber, polyisoprene rubber, butyl rubber, silicone rubber and the like.

  The thickness of the plaster layer of the present invention varies depending on the purpose of use, but when it becomes thinner, the drug content per unit area of the plaster preparation becomes insufficient and adhesion becomes insufficient, and when it becomes thicker, the plaster layer near the support The pharmaceutically active ingredient contained does not diffuse sufficiently, and the drug release is reduced. For this reason, 20-500 micrometers is preferable.

  As the support of the present invention, it is a conventional practice to select a flexible material in order to fit the affected area without the components of the paste layer passing through, but the plaster of the present invention In this case, a flexible material is selected because one side of the two plaster agents is easily turned over by moving the bent portion in the direction of the short side of the plaster agent while bending the release liner when attaching. . For example, elastic woven or non-woven fabric can be mentioned.

  Examples of the material of the release liner of the present invention include polyesters, polypropylenes, polyethylenes, alkylbenzene sulfonic acids, polyvinyl chlorides and metal films.

  The medicinally active ingredient used for the plaster of the present invention is not particularly limited as long as it is a drug which can be so-called percutaneously absorbed. For example, anti-inflammatory analgesics, blood circulation promoting agents, hypotensive agents, diuretics, anti-allergic agents, anti-asthmatic agents, coronary vasodilators, bronchodilators, beta blockers, cancer pain therapeutic agents, smoking cessation aids, etc. Can.

  Examples of the anti-inflammatory and analgesic agent used for the plaster provided by the present invention include flurbiprofen, felbinac, methyl salicylate, glycol salicylate, indomethacin, ketoprofen and the like. Examples of the blood circulation promoting agent include nonylic acid allilic acid, capsaicin, benzyl nicotinate and the like.

  Moreover, as an antihypertensive agent, for example, clonidine, clonidine hydrochloride, atenolol, propranolol, propranolol hydrochloride, nicardipine hydrochloride, pufranol, metoprolol tartrate, captopril, indolol, nipadibin etc. can be mentioned. Furthermore, as the diuretic, for example, acetazolamide, potassium canrenate, chlorthalidone, spironolactone, trichloromethiazide, furosemide, hydrothiazide, hydroflumethiazide and the like can be mentioned.

  Moreover, examples of the anti-allergic agent include diphenhydramine hydrochloride, cyproheptane hydrochloride, homochlorcyclidine hydrochloride, clemastine fumarate, chlorpheniramine maleate, mequitazine and the like. Examples of the anti-asthmatic agent (antitussive agent) include ephedrine hydrochloride, methyl ephedrine hydrochloride, pentoxiverine citrate, dextromethorphan hydrobromide, terptazone sulfate, isoproterenol hydrochloride and the like.

  In addition, as coronary vasodilators, for example, nitroglycerin, nitroglycol, isosorbide dinitrate, dipyridamole, morisidamine and the like can be mentioned. Examples of bronchodilators include trimetoquinol hydrochloride, procaterol hydrochloride, mabuterol hydrochloride, salbutamol sulfate, theophylline, tulobuterol and the like.

  In addition, in the plaster of the present invention, a refreshing agent such as L-menthol, a bactericidal agent, an antioxidant such as dibutyl hydroxytoluene, a moisturizing agent such as isopropyl myristate, and the like can be optionally added.

  FIG. 1 is an explanatory view showing the constitution of an embodiment of the plaster preparation of the present invention, wherein a is a plan view, b is a side view and c is a front view including a partially enlarged view. Fig. 2 is an explanatory view showing the process of producing the plaster preparation shown in Fig. 1, wherein a is a step of forming a laminate, b is a step of half cutting a central region, and c is a half cut region. The removal step, FIG. D shows cutting the two plasters together with the release liner, FIG. E shows removing the punched both sides, and the f shows a cut out of the plaster preparation shown in FIG.

  FIG. 3 is an explanatory drawing showing continuous production of the plaster preparation shown in FIG. FIG. 4 is an explanatory view showing another manufacturing than the half cutting and cutting process shown in FIG. 3 b. FIG. 5 is a front view of the cutting drum used in the half cut shown in FIG. 3 or FIG. FIG. 6 is a front view of a cutting drum used in the full cut shown in FIG. 3 or FIG.

  As shown in FIG. 1, the plaster preparation 10 of the present example includes two substantially rectangular plasters 12 whose longitudinal sides are curved. The two plasters 12 are pasted on one release liner 18 at a distance of 5 mm so that the short sides of each other are separated by a predetermined distance. The plaster agent 12 includes a plaster layer 14 spread on the lower surface of the support 16, and further, a release liner 18 is attached to the lower surface of the plaster layer 14. The release liner 18 between the two plasters 12 is formed with a perforation 20 through which the release liner 18 can be broken.

  Four corners of the plaster preparation 10 in which two plasters 12 are stuck on one release liner 18 are rounded and rounded, and the curved long sides and the short sides of both sides are also broken together with the release liner. . The opposite corners where the short sides of the two opposing plasters 12 face each other at a predetermined distance are also chamfered in the same manner as the four corners of the plaster preparation, leaving the release liner 18.

  In order to remove one plaster agent 12 from this plaster preparation 10, one of the two plaster agents can be removed by moving the bent portion in the direction of the short side of one plaster agent 12 while bending the central portion of the release liner 18 The opposite sides can be easily flipped up and easily removed from the release liner 18. In addition, the plaster agent 12 removed from the release liner 18 is such that the longitudinal side is curved and the four corners are rounded and chamfered. For this reason, by sticking to the affected area along the side surface of the rounded affected area whose diameter changes toward the end in the longitudinal direction, since the wrinkles are adhered without turning, the joint of the movable part It is hard to come off even in the affected area such as the periphery, and the medicinal component is also effectively administered.

  Plaster formulation 10 of this example is manufactured as follows. As shown in FIG. 3A, the release liner tape 28, which becomes the release liner 18 when cut, is carried out while being released from the release liner roll 38. The width of the release liner tape 28 is longer than the longitudinal sides of at least two substantially rectangular plasters.

  The paste base layer 34 is transferred onto the release liner tape 28 to spread the paste base layer 24. The paste base 34 was obtained by the following steps. That is, a styrene-isoprene-styrene block copolymer (hereinafter abbreviated as SIS), polyisobutylene, alicyclic saturated hydrocarbon resin and liquid paraffin were heated and kneaded at 100 ° C to 150 ° C. Thereafter, as an active ingredient, indomethacin as an anti-inflammatory analgesic and other additives were added and kneaded to obtain a paste base 34.

  The obtained paste base 34 is conveyed while spreading from the lower side of the base tank 33 through the first transfer roll 35 to the second transfer roll 37 as the paste base layer 24 on the entire surface of the release liner tape 28 Ru. Furthermore, the support tape 26 which becomes the support 12 when cut is carried out while being unwound from the support roll 32 downstream in the transport direction, is stuck on the surface of the paste base layer 24 and is transported It is applied by the pressure roller 39 and conveyed downstream as the plaster agent tape 22.

  As shown in FIG. 3 b and FIG. 2, the laminate of the release liner tape 28, the paste base layer 24 and the support tape 26 (FIG. 2 a) is a cutting for half cutting shown in FIG. 5. The drum 50 is punched out of the area at the center of the direction of conveyance of the plaster agent tape 22 leaving the release liner tape 28 (FIG. 2b).

  The stamped central area 54 is removed upwardly from the conveyed plaster tape 22 (FIG. 2c). The plaster agent tape 22 from which the central region 54 has been removed is a cutting drum 60 for full cutting shown in FIG. 6 disposed downstream, and the release liner tape 28, the plaster base layer 24 and the support tape 26. The two substantially rectangular plasters whose longitudinal sides are curved from the laminate with the above are punched out along with the release liner tape 28 with the plaster agent tape 22 in a shape in which the short sides of each other are separated by a predetermined distance. It is cut and divided into the plaster preparation 10 and the area 64 on both sides (FIG. 2d).

  Note that, at the time of punching and cutting by the cutting drum 60, the cutting drum 60 is supported from below by the support drum 62. In order to insert perforations 20 into the release liner tape 28 from below when punching with the cutting drum 60, a projection (not shown) of a perforation cutter at the center of the support drum 62 that supports the cutting drum 60 from below. Is formed. The stamped and cut two-sided area 64 is removed upwards (Fig. 2e) from the transport path (not shown) through which the individual plaster formulation 10 is transported and separated from the plaster formulation 10 (Fig. 2). F figure).

  Although the support drums 52 and 62 are separately installed with the cutting drum 50 for half cutting and the cutting drum 60 for all cuttings as shown to b figure of FIG. 3, as shown in FIG. 52 and 62 may be used as the large support drum 40 of one diameter. This brings about the advantage that it is easy to align the shape of the plaster agent tape 22 which is individually punched out. As mentioned above, although the process of punching out plaster formulation 10 continuously from a layered product using a roll-like liner tape using a support tape was shown, the two pieces of plaster formulation 10 are previously punched out to obtain individual plaster agent. It may be a step of removing the 12 short sides.

10 ... plaster formulation,
12 ... plaster agent,
14 ... plaster layer,
16 ... support,
18 ... release liner,
20 ... perforation,
22 ... Plaster tape,
24 ... plaster base layer,
26 ... Support tape,
28 ... Peeling liner tape,
32: Support roll,
33: Base tank,
34 ... plaster base,
35: First transfer roll,
37: Second transfer roll,
38 ... Peeling liner roll,
39: Press-contact roller,
40 ... large diameter support drum,
50 ... Cutting drum for half cut,
52: Support drum,
54 ... area of the central part punched out,
60 ... Cutting drum for all cuts,
62 ... supporting drum,
64 ... area of both sides stamped and cut,

Claims (6)

A plaster agent comprising a plaster layer having a medicinal component mixed therein and a support applied on one side of the plaster layer, and the other side of the plaster layer of the plaster preparation being stuck A plaster formulation with a release liner,
The two substantially rectangular plasters are pasted on one release liner so as to face each other with a predetermined distance therebetween.
A plaster preparation characterized in that each of the substantially rectangular plasters has a curved longitudinal side.   The plaster preparation according to claim 1, wherein the plaster layer is a plaster layer obtained by kneading a medicinal component with a hot melt adhesive.   The plaster preparation according to claim 1 or 2, wherein four corners at which the curved longitudinal side and the short side intersect each other are rounded and chamfered into a rounded rectangular shape. A plaster agent comprising a plaster layer having a medicinal component mixed therein and a support applied on one side of the plaster layer, and the other side of the plaster layer of the plaster preparation being stuck A method of producing a plaster formulation with a release liner,
A plaster layer of plaster agent tape of the same width is pasted to a release liner tape having a width longer than the length of two long sides of a predetermined substantially rectangular plaster agent, and the plaster agent tape and the release liner A laminate forming step of obtaining a laminate;
A half-cut step of punching out a region of a central portion of the plaster agent tape from the obtained laminate, leaving the release liner;
A half-cut removal step to remove the central area of the punched plaster agent tape;
Release the plaster agent tape from the laminate after the half-cut removal step so that the two substantially rectangular plaster agents whose longitudinal sides are curved face each other with the short sides separated by a predetermined distance. And a step of cutting together with the above.   After the laminate forming step spreads and applies a plaster layer obtained by kneading a medicinal component with a hot melt adhesive on the release liner tape, a backing tape is adhered to the plaster layer to form a laminate of plaster plaster. The method for producing a plaster preparation according to claim 4, which is obtained.   The plaster preparation that has been subjected to the half cutting step and the cutting step is punched and cut so as to be a rounded, substantially rectangular plaster agent in which four corners where a long side and a short side intersect are curved and rounded. A method of producing a plaster preparation according to claim 4 or 5, characterized in that

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