JP3158519U - A patch with excellent removability from a packaging bag and operability during application - Google Patents

Abstract

An object of the present invention is to provide a sticking operability by ensuring ease of taking out from a packaging bag and having an appropriate support property even when glue sticking out occurs without depending on the type, configuration and thickness of the adhesive. Providing a good patch. A support having a pressure-sensitive adhesive layer formed on one side thereof, a release liner that covers the entire surface of the pressure-sensitive adhesive layer and has an extending portion that extends outward from all edges of the pressure-sensitive adhesive layer, and the support And a peelable backing film having an extending portion that is laminated on the body and extends outward from all edges of the support. [Selection] Figure 2

Description

  The present invention relates to a patch that is easy to take out the patch enclosed in a packaging bag and excellent in operability at the time of sticking.

  The patch is usually composed of a support body, a patch body comprising an adhesive layer laminated on one side of the support, and a peelable release liner covering the entire surface of the adhesive layer. Further, the adhesive layer may contain a transdermally absorbable drug, and these patches are usually marketed and stored in a state of being enclosed in a packaging bag as a product.

  However, depending on the type of pressure-sensitive adhesive used and the amount of liquid component added to the pressure-sensitive adhesive, the cohesive strength of the pressure-sensitive adhesive may be insufficient. In addition, the pressure-sensitive adhesive layer may be thickened in order to increase the drug content for the purpose of maintaining the blood concentration of the drug. In these cases, “glue sticking out” may occur in which part of the adhesive layer flows out from the edge of the patch. When paste sticks out, the patch adheres to the inner surface of the packaging bag, making it difficult to remove from the packaging bag. Moreover, when it contains a drug, it may cause a decrease in drug efficacy due to drug outflow. Further, when sticking to the skin surface, problems such as sticking operability such as contamination of the adhesive surface due to contact of the protruding glue with the fingers, a decrease in adhesive strength, and unsanitary may occur.

  Up to now, various efforts have been made to suppress the sticking out of the glue. For example, a method of crosslinking the pressure-sensitive adhesive (Patent Document 1), a method of curing the pressure-sensitive adhesive such as introducing pseudo-crosslinking to the pressure-sensitive adhesive having no functional group capable of crosslinking reaction (Patent Document 2), and the like. . However, in the method of crosslinking the pressure-sensitive adhesive layer, the pressure-sensitive adhesive strength decreases due to the hardened pressure-sensitive adhesive, and the operability may be impaired. In some cases, a crosslinking agent cannot be used from the viewpoint of drug stability.

  As another method, there is a method in which the release liner has an extending portion extending outside all the edge portions of the adhesive layer, and even if paste sticks out, the contact with the packaging bag or fingers is reduced. As a system, there has been proposed a patch in which an essential part of an extended part of a release liner is embossed (Patent Document 3). However, embossing increases the volume in the packaging bag and increases the oxygen concentration, which may affect drug stability. Furthermore, it is not preferable in terms of time and cost, such as a decrease in yield due to embossing and an increase in processes.

Moreover, in order not to impair the pasting operability, a technique has been proposed in which a backing film is provided on the surface opposite to the surface having the adhesive layer of the support (Patent Document 4). Even though the operability is improved because rigidity is imparted by this method, the backing film, the support, the pressure-sensitive adhesive layer, and the release liner are flush with each other at the end surface, so that it cannot be said that it is an effective measure against glue sticking out.
Accordingly, there is a need for a patch that retains excellent operability at the time of sticking and has good removability from a packaging bag.

Japanese Patent No. 2700835 JP 2004-217860 A Japanese Utility Model Publication No. 4-51782 JP 7-16258 A

  The present invention has been made in view of such circumstances, and the problem to be solved is not dependent on the type, configuration, and thickness of the pressure-sensitive adhesive, and even when paste sticks out, it is a packaging bag. It is an object of the present invention to provide a medicated patch containing a drug that can ensure good take-out properties from the tablet and has good supportability by having an appropriate support.

  As a result of intensive studies, the present inventors have found that the patch covers the entire surface of the pressure-sensitive adhesive layer and the support having the pressure-sensitive adhesive layer formed on one side, and extends outward from all edges of the pressure-sensitive adhesive layer. Surprisingly, it has a release liner having a protruding portion and a peelable backing film having an extended portion that is laminated on the support and extends outward from all edges of the support. The extending portion becomes a gripping portion and contributes to improvement in operability at the time of sticking, and can prevent the paste from sticking out to the support side, thereby completing a patch excellent in the ability to be taken out from the packaging bag. That is, this invention includes the content shown below.

[1] A support having a pressure-sensitive adhesive layer formed on one side, a release liner that covers the entire surface of the pressure-sensitive adhesive layer, and has an extending portion that extends outward from all edges of the pressure-sensitive adhesive layer;
A peelable backing film having an extended portion laminated on the support and extending outward from all edges of the support.
[2] The patch according to [1], wherein the release liner is provided with a slit for peeling the release liner from the pressure-sensitive adhesive layer.
[3] The sticking according to [1] or [2], wherein the extending part of the backing film is 2 mm or more longer than the edge of the support and has a length not longer than the extending part of the release liner. Agent.
[4] The patch according to any one of [1] to [3] above, wherein the adhesive layer further contains a drug.
[5] The patch according to any one of [1] to [4], which is individually packaged in a packaging bag.

  The patch of the present invention is easy to take out the patch enclosed in the packaging bag, is excellent in operability at the time of pasting, and further contains a drug in the adhesive layer. Prevents drug outflow.

It is the plane schematic diagram and side surface schematic diagram of the patch of one Embodiment which concerns on this invention. It is a side enlarged view of the patch of FIG. It is the plane schematic diagram and side surface schematic diagram of the patch of other embodiment which concerns on this invention. It is a schematic diagram which shows the manufacturing process of the patch of one Embodiment which concerns on this invention.

  The present invention will be described below with reference to the drawings. In addition, in order to clarify each element in a figure, the dimensional ratio between elements is different from the actual.

1 to 3 are a schematic plan view and a schematic side view of an embodiment of the patch 1 according to the present invention. The patch 1 of the present invention has a pressure-sensitive adhesive layer 4 formed on one surface of a support 3 and a release liner 5 covering the pressure-sensitive adhesive layer 4, and a backing film 2 on the other surface of the support 3. Have. The feature of the patch 1 of the present invention is that the backing film 2 and the release liner 5 extend from the end of the support 3 around the entire circumference of the support 3. That is, the backing film 2 has an extending portion 2 </ b> A protruding from the end portion of the support 3, and at the same time, the release liner 5 also has an extending portion 5 </ b> A protruding from the end portion of the support 3. .
By adopting this configuration, the patch 1 can suppress sticking of the adhesive to the support side, and the operability is improved because the extending portion of the backing film 2 becomes a grip portion after the pasting.

  The release liner 5 preferably has a slit (also referred to as a back cut) 6. It is preferable that the slit 6 penetrates substantially the center of the release liner 5. The slit 6 may be a straight line as illustrated in FIG. 1 or a curved line as illustrated in FIG. 3, and may be wavy, serrated, or jagged, and is not limited to one. A plurality may be provided. The slit 6 also has a function as a grip portion of the release liner 5 and facilitates the release liner 5 to be peeled off.

  As shown in FIG. 2, the patch 1 of the present invention is such that the extending part 2 </ b> A of the backing film 2 is preferably 2 mm or longer than the edge part of the support 3 and the length of the extending part 5 </ b> A or less of the release liner 5. It is preferable. Since the extending part 2A of the backing film 2 protrudes from the edge of the support 3, the extending part 2A of the backing film 2 becomes a gripping part, and the operability of the patch 1 is further improved. The paste to the 3 side can be more effectively suppressed.

In FIG. 2, the dimension L2 of the backing film 2 is preferably larger by 2 mm or more at both ends than the dimension L1 of the support 3, and is preferably less than or equal to the dimension L3 of the release liner 5. That is, the dimension L2 of the backing film 2 is preferably in the range of the following formula (I).
L3 ≧ L2 ≧ (L1 + 4 mm) (I)

(Patch shape)
The shape and size of the patch are not particularly limited.
As the shape of the support 3, a rectangle such as a circle, an ellipse, a square and a rectangle, a substantially rectangle, a long shape, a substantially polygon, and the like can be adopted. Moreover, you may cut a rectangular corner | angular part roundly.
The dimensions of the support 3 are not particularly limited, and may be, for example, a circle having a diameter of 5 to 200 mm, a square having a side of 5 to 200 mm, a rectangle such as 30 mm × 20 mm, or a larger size. Further, as shown in the formula (I), the size of the backing film 2 is preferably 2 mm or more at both ends with respect to the size of the support 3 and preferably less than or equal to the size of the release liner 5. Further, the size of the release liner 5 is not particularly limited, but it is not necessary to make it too large with respect to the size of the support 3, so that it extends at a width of 2 mm or more and 10 mm or less at both ends of the support 3. It is preferable that the length is 2 mm or more and 5 mm or less. By setting the extending portion from the end portion of the support within this range, it is possible to secure a grip margin for the release liner 5 and facilitate peeling, and the dimensions of the patch and the packaging bag do not become too large.
Specifically, for example, when the support 3 is approximately 30 mm × 20 mm, the size of the backing film 2 is preferably larger by 2 mm or more than the outer periphery of the support 3, and is 34 mm × 24 mm or more, And it is preferable that it is below the dimension of the release liner 5. FIG. Therefore, for example, when the dimension of the release liner 5 is a dimension (40 mm × 30 mm) that extends 5 mm at both ends with respect to the dimension of the support 3, the dimension of the backing film 2 is 34 mm × 24 mm or more, And it is preferable that it is 40 mm x 30 mm or less.
In the above example, the backing film 2 is extended to the support 3 with the same dimensions at both ends, but the support 3 is extended 2 mm from one end, For example, the shape may extend 3 mm from the other end. Similarly, with respect to the release liner 5, the extension dimension at both ends of the support 3 may be different.

(Adhesive layer)
The pressure-sensitive adhesive layer used in the present invention obtains a composition by blending and mixing a pressure-sensitive adhesive in the presence of a solvent together with components such as a drug, an organic liquid component, and a tackifier as needed, and then applying this composition. It can be formed by layering by a method such as, and drying.

  Although it does not specifically limit as an adhesive which comprises an adhesive layer, Acrylic, a synthetic rubber type, a natural rubber type, and a silicone type adhesive are mentioned from points, such as skin adhesiveness. Acrylic adhesives are preferred because of their stability in quality, ease of preparation, drug release, and low irritation imparted to the skin. In addition, a rubber-based pressure-sensitive adhesive is preferable because the present invention functions particularly effectively for a patch using a soft and thick pressure-sensitive adhesive layer.

  The acrylic pressure-sensitive adhesive is made of an acrylic polymer, and examples of the acrylic polymer include a homopolymer of (meth) acrylic acid alkyl ester or a copolymer thereof. Examples of rubber adhesives include polyisobutylene / polybutene, styrene / diene / styrene block copolymer, styrene / butadiene, nitrile, chloroprene, vinylpyridine, polyisobutylene, butyl, isoprene / isobutylene. Examples thereof include rubber-based pressure-sensitive adhesives made of a system.

  The blending ratio of the acrylic pressure-sensitive adhesive is preferably 10 to 95% by weight, more preferably 20 to 90% by weight. When the amount is less than 10% by weight, the cohesive strength of the adhesive is insufficient, and the skin adhesiveness tends to be insufficient. When the amount exceeds 95% by weight, the compounding amount of the drug and other optional components does not become an effective amount. There is.

  The rubber-based pressure-sensitive adhesive can be used by mixing the same component or different components having different average molecular weights in order to obtain appropriate adhesive strength and drug solubility. For example, when polyisobutylene is described as an example, a high molecular weight polyisobutylene having a viscosity average molecular weight of 1,800,000 to 5,500,000, a medium molecular weight polyisobutylene having a viscosity average molecular weight of 40,000 to 85,000, And if necessary, a mixture with a lower molecular weight polyisobutylene is preferred. The viscosity average molecular weight in the present invention is obtained by calculating the Staudinger index (J0) from the flow time of the capillary 1 of the Ubbelohde viscometer at 20 ° C. by the Schulz-Blaschke equation and using this J0 value by the following equation. Is.

  Here, high molecular weight polyisobutylene is 10 to 80 wt%, preferably 10 to 50 wt%, medium molecular weight polyisobutylene is 0 to 90 wt%, preferably 10 to 80 wt%, and low molecular weight polyisobutylene is 0 wt%. It is suitable to blend in a proportion of ˜80 wt%, preferably 0 to 60 wt%.

  The thickness of the pressure-sensitive adhesive layer is preferably 100 to 200 μm from the viewpoint of securing the adhesive force and suppressing the sticking out.

  The pressure-sensitive adhesive layer may be a cross-linked pressure-sensitive adhesive layer that has been subjected to a crosslinking treatment, or may be a non-cross-linked pressure-sensitive adhesive layer that has not been subjected to a cross-linking treatment. Here, the crosslinking treatment means that the skin adhesive strength of the patch preparation is sufficiently maintained, and that the skin irritation such as pulling the skin when the patch preparation is peeled off from the skin surface and physically peeling the stratum corneum of the skin is kept low. In order to make this compatible, it refers to a known treatment applied to the pressure-sensitive adhesive layer. Examples of the crosslinking treatment include chemical crosslinking treatment, ionic crosslinking treatment, and physical crosslinking treatment with electron beam or ultraviolet ray. Examples of the crosslinking agent include metal salts such as zinc acetate, epoxy compounds, amide compounds, amine compounds, acid anhydrides, peroxides, isocyanate compounds, and the like.

  The solvent is preferably an organic solvent and is not particularly limited, but is preferably a solvent that is compatible with the above-described components constituting the pressure-sensitive adhesive layer and can be easily volatilized in the drying step. Examples of the organic solvent include aromatic hydrocarbons such as toluene and xylene, aliphatic hydrocarbons such as hexane, esters such as ethyl acetate, alcohols such as ethanol, ethers such as diethyl ether and tetrahydrofuran, and the like. These may be used alone or in combination of two or more.

  The drying may be performed by air drying, or may be performed by a known method using a drying device, hot air, far infrared rays, or the like.

  The mixing method of each component is not limited, and examples thereof include a kneader such as a kneader and a planetary mixer, a disperser such as a homogenizer, and a stirrer such as a propeller type blade stirrer. These can be used alone. A combination of more than one species can also be used.

  In the patch of the present invention, the adhesive layer can optionally contain a drug depending on the purpose of treatment. The drug here is not particularly limited, and a drug that can be administered through a skin to a mammal such as a human, that is, a transdermally absorbable drug is preferable. Specific examples of such drugs include general anesthetics, hypnotics and sedatives, antidepressants, antipyretic analgesics, antipruritics, neuropsychiatric drugs, local anesthetics, skeletal muscle relaxants, Autonomic drugs, antispasmodics, antiparkinson drugs, antihistamines, cardiotonic drugs, arrhythmia drugs, angina treatment drugs, diuretics, antihypertensive drugs, vasoconstrictors, coronary vasodilators, peripheral vasodilators, Arteriosclerotic drugs, cardiovascular drugs, respiratory accelerators, bronchodilators, antitussive expectorants, hormone drugs, topical suppurative drugs, analgesic / antipruritic / convergent / anti-inflammatory drugs, parasitic skin disease drugs, hemostatic drugs Drugs, drugs for treating gout, drugs for diabetes, drugs for antineoplastic tumors, antibiotics, chemotherapeutic drugs, narcotics, smoking cessation aids, etc.

  The ratio of the drug in the pressure-sensitive adhesive layer is not particularly limited as long as it satisfies the effect of the drug for transdermal absorption and does not impair the pressure-sensitive adhesive properties of the pressure-sensitive adhesive, but the total weight of the pressure-sensitive adhesive layer (however, the pressure-sensitive adhesive layer Is preferably 0.1 to 60% by weight, more preferably 0.5 to 40% by weight, based on the weight of the crosslinking agent. If the amount is less than 0.1% by weight, the therapeutic effect may not be sufficient. If the amount is more than 60% by weight, skin irritation may occur, which may be economically disadvantageous.

  If desired, the pressure-sensitive adhesive layer can contain an organic liquid component. The organic liquid component is not particularly limited, and glycols such as ethylene glycol, diethylene glycol, propylene glycol, dipropylene glycol, tripropylene glycol, triethylene glycol, polyethylene glycol, polypropylene glycol; and oils such as olive oil, castor oil, and lanolin Hydrocarbons such as squalane and liquid paraffin; various surfactants; ethoxylated stearyl alcohol; glycerin monoesters such as oleic acid monoglyceride, caprylic acid monoglyceride, lauric acid monoglyceride; dialkyl esters of polyalkylene glycols such as polypropylene glycol Glycerin diesters such as glycerin diacetate, glycerin triesters such as glycerin triacetate Or fatty acid alkyl esters such as triethyl citrate; long chain alcohols; higher fatty acids such as oleic acid and caprylic acid; alkyl esters of higher fatty acids such as isopropyl myristate and isopropyl palmitate; N-methylpyrrolidone; Examples include pyrrolidones such as N-dodecylpyrrolidone; sulfoxides such as decylmethyl sulfoxide; 1,3-butanediol and the like. These may be used alone or in combination of two or more.

  In order to impart appropriate tackiness to the pressure-sensitive adhesive layer, for example, a tackifier such as rosin-based resin, polyterpene resin, coumarone-indene resin, petroleum-based resin, terpene-phenol resin, and xylene resin is blended. These may be used alone or in combination of two or more. Examples of the petroleum resins include aliphatic (C5) petroleum resins, aromatic (C9) petroleum resins, copolymer (C5-C9) petroleum resins, and aromatic (C9) petroleum resins. Examples include alicyclic saturated hydrocarbon resins obtained by partial hydrogenation or complete hydrogenation. The alicyclic saturated hydrocarbon resin preferably has a softening point (ring and ball method) of 90 to 150 ° C. Although it does not limit as a compounding quantity of a tackifier, 10-40 weight% is illustrated from a viewpoint which provides moderate tackiness and does not saturate the effect of the tackifier accompanying the increase in a compounding quantity.

(Support)
The support is not particularly limited as long as it can adapt to the skin, but is substantially impermeable such as a drug, that is, the active ingredient or additive of the adhesive layer passes through the support and is on the back surface. Those which are lost from the above and do not cause a decrease in the content are preferred.

  Specific examples include paper, woven fabric, non-woven fabric, knitted fabric, mechanically perforated film / metal foil, and laminates thereof. Of these, paper, woven fabric, non-woven fabric and laminates thereof are particularly preferred from the viewpoint of handleability and the like, and a laminate of nonwoven fabrics is particularly preferred.

  Materials include, for example, polyester, nylon, saran (Asahi Kasei Chemicals Co., Ltd., registered trademark of Dow Chemical Co., USA), polyethylene, polypropylene, polyvinyl chloride, ethylene-ethyl acrylate copolymer, polytetrafluoroethylene, and Surlyn. (Registered trademark of US DuPont) or a combination thereof. From the viewpoint of securing anchorage with the pressure-sensitive adhesive, a laminate of polyethylene terephthalate (hereinafter sometimes abbreviated as PET) and a PET nonwoven fabric is preferable.

  Although the thickness of a support body is not specifically limited, The range of 20-40 micrometers is preferable from a viewpoint of followable | trackability to skin and prevention of peeling after sticking.

(Release liner)
The material of the release liner provided on the pressure-sensitive adhesive layer is not particularly limited, and examples thereof include those known per se. Specifically, PET and other polyesters, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, various acrylic and methacrylic polymers, polystyrene, polycarbonate, polyimide, cellulose acetate, regenerated cellulose (cellophane), celluloid and other plastics Examples thereof include a film or a laminate film of fine paper or glassine paper and polyolefin and the like. A release liner can be obtained by applying a silicone resin treatment or a fluororesin treatment to these surfaces. In view of safety, economy, and drug migration, it is preferable to use a product treated with a silicone resin.

  The thickness of the release liner is usually from 10 to 200 μm, preferably from 50 to 100 μm, based on the results of patches containing drugs that have been developed so far.

(Backing film)
Examples of the material of the peelable backing film include a plastic film and paper. Further, a resin film such as polyester or polyolefin can be applied to these surfaces to obtain a peelable backing film. Preferably, the surface of the paper is subjected to a resin treatment such as polyester.

  The thickness of the backing film is preferably 20 to 100 μm from the viewpoint of obtaining rigidity.

  As described above, the extending part of the backing film is preferably 2 mm or more longer than the edge of the support and has a length equal to or shorter than the extending part of the release liner. The extending portion secures a margin for gripping, so that the backing film is easily peeled off.

(Embodiment)
The manufacturing process of the patch of one embodiment according to the present invention will be described with reference to FIG.

(S01) The pressure-sensitive adhesive layer 10 is formed by applying a pressure-sensitive adhesive to one side of the long release liner 11.
(S02) The support 12 surface of the laminate in which the long support 12 and the backing film 13 are previously bonded is bonded to the pressure-sensitive adhesive layer 10 formed on the release liner 11. In addition, in order to bond the support body 12 and the backing film 13, well-known methods, such as inflation molding, extrusion lamination molding, lamination molding, and casting, can be used.
(S03) The support 12, the pressure-sensitive adhesive layer 10 and the peeling are performed by half-cutting both ends in the width direction of the long laminate composed of the backing film 13, the support 12, the pressure-sensitive adhesive layer 10 and the release liner 11. Slits 14 are provided in the three layers of the liner 11. The outer support 12, the pressure-sensitive adhesive layer 10, and the release liner 11 are removed from the slit 14 so that only the backing film 13 remains.
(S04) The release liner 11 is peeled off.
(S05) The second release liner 15 wider than any of the backing film 13, the support 12, and the pressure-sensitive adhesive layer 10 is bonded again on the pressure-sensitive adhesive layer 10.
(S06) The slit 16 is provided at the center of the release liner 15.
Both ends in the width direction of the backing film 13 are cut with a blade so that the long backing film 13 has a predetermined width (S07), and the backing film 13 at both ends is removed (S08).
(S09) The second release liner 15 is punched out (total patch removal). The punching means is not particularly limited, and examples thereof include a laser and a push cutting blade. Since it is easy to adjust and align the cutting dimensions and to obtain a clean end face, it is preferably punched with a press cutting blade die set (male type and female type).

  The patch according to the present invention may be individually packaged in a packaging bag.

  The present invention is easy to take out the patch encapsulated in the packaging bag, is excellent in operability at the time of application, and when the adhesive layer contains a drug, the drug in the packaging bag It can be suitably used as a patch capable of preventing outflow.

DESCRIPTION OF SYMBOLS 1 Patch 2 Backing film 2A Backing film extension part 3 Support body 4 Adhesive layer 5 Release liner 5A Release liner extension part 6 Slit 10 Adhesive layer 11 Release liner 12 Support body 13 Backing film 14 Slit 15 Second Release liner 16 slit

Claims (5)

A support having an adhesive layer formed on one side;
A release liner that covers the entire surface of the pressure-sensitive adhesive layer and has an extending portion that extends outward from all edges of the pressure-sensitive adhesive layer;
A peelable backing film that is laminated on the support and has an extension extending outward from all edges of the support;
A patch having   The patch according to claim 1, wherein the release liner is provided with a slit for peeling the release liner from the pressure-sensitive adhesive layer.   The patch according to claim 1 or 2, wherein the extending part of the backing film is 2 mm or more longer than the edge of the support and is not longer than the extending part of the release liner.   The adhesive patch according to any one of claims 1 to 3, wherein the adhesive layer further contains a drug.   The patch according to any one of claims 1 to 4, which is individually packaged in a packaging bag.

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