The present invention relates to a patch package structure including a package and a patch disposed in the package.
Patches to be applied to the skin for the purpose of protecting the affected part and patch preparations to be applied to the skin of a mammal for the purpose of percutaneously administering a drug to the mammal have hitherto been developed. Such patches or patch preparations (hereinafter inclusively referred to as patches unless otherwise indicated) are being sold on the market generally in the form of a package structure including the patch disposed in a bag-form package (see, for example, JP-UM-B-4-51782). Such a bag-form package is generally made of a flexible resin film or the like and, hence, it is not difficult to open the bag-form package by tearing it by hand.
However, use of such a bag-form package has the following drawback. The patch is in close contact with the package, and a load is apt to be imposed on the patch from outside the package. Because of this, a component of the pressure-sensitive adhesive layer is apt to leak out through or protrude from a peripheral or other part of the patch, whereby the patch adheres to the inner surface of the package. The patch hence tends to be difficult to take out of the package.
JP-T-10-511330 (the term “JP-T” as used herein means a published Japanese translation of a PCT patent application) discloses a patch package structure including a package having a given container shape and a patch disposed therein. The patch disposed in such a package is less apt to receive a load from outside the package as compared with the patch in a bag-form package. This patch package structure hence is inhibited from suffering the trouble that a component of the pressure-sensitive adhesive layer leaks out through or protrudes from a peripheral part of the patch. Consequently, the patch is inhibited from adhering to the inner surface of the package.
However, such a container-shape package generally includes a material having some degree of rigidity so as to retain an almost constant shape, and it is hence generally necessary to use scissors or the like for opening the package and it is difficult to open this package by hand.
Under the circumstances described above, an object of the invention is to provide a patch package structure in which the patch is inhibited from adhering to the inner surface of the package and the package can be easily opened by hand.
In order to solve the above-mentioned object, the present invention provides the following items 1 to 10.
1. A patch package structure which comprises a package and a patch disposed in the package,
the package comprising a first sheet material which is substantially planar and a second sheet material which has been molded,
the second sheet material having a first region which projects outward from the package and a second region which surrounds the first region and is substantially planar,
the first region having a planar outer shape which includes a planar outer shape of the patch, and
the second region having a first sealed region which surrounds the first region and an unsealed region located nearer to a central part of the second sheet material than the first sealed region.
2. The patch package structure according to item 1, wherein the second sheet material has, in the unsealed region, a close-contact region in which the second sheet material is in close contact with the first sheet material.
3. The patch package structure according to item 2, wherein the close-contact region is a second sealed region.
4. The patch package structure according to item 3,
wherein the package has an opening initiation part in a peripheral area of the package, and
wherein the opening initiation part is located in such a position that when the package is torn at the opening initiation part, a tear is formed in the package and the tear extends to the unsealed region.
5. The patch package structure according to item 3, wherein the second sealed region has a dot-form planar shape.
6. The patch package structure according to item 3, wherein the second sealed region has a strip-form planar shape.
7. The patch package structure according to item 3, wherein the second sealed region has a substantially triangular planar shape.
8. The patch package structure according to item 3,
wherein the boundary between the first region and the second region has a substantially rectangular shape having a first side and a second side adjoining the first side;
the second region having the unsealed region extending along the first side; and
the unsealed region having at least two second sealed regions.
9. The patch package structure according to item 3,
wherein the boundary between the first region and the second region has a substantially rectangular shape having a first side and a second side adjoining the first side;
the second region having the unsealed region extending along each of the first side and the second side; and
the unsealed region each having at least one second sealed region.
10. The package structure according to any one of items 1 to 9, wherein the patch is a patch preparation containing a drug.
According to the invention, since the patch is disposed in the package described above, the patch can be inhibited from receiving an external load and the patch can hence be inhibited from adhering to the inner wall of the package. In addition, since the package has a sealed region and an unsealed region as described above, the patch package structure of the invention can be opened more easily than conventional patch package structures.
Preferred embodiments of the invention are shown below. However, the following detailed explanations thereon and specific examples are intended only for exemplification and should not be construed as limiting the scope of the invention. The following explanations on preferred embodiments are merely illustrative and are never intended to limit the invention and the applications or uses thereof.
The invention is explained in more detail by reference to the accompanying drawings, in which constituent elements are indicated by reference numerals.
Reference is made to
As used herein, the phrase “a component of a pressure-sensitive adhesive layer” is meant to encompass not only one component of a pressure-sensitive adhesive layer but also a plurality of components and a composition thereof.
In
The sizes of the patch and package vary depending on the intended use of the patch. However, in the case where they have a substantially rectangular planar outer shape, the sizes thereof in a specific example are as follows. In a specific example, the patch has a substantially rectangular shape in which a first side has a length of about 20-100 mm and a second side has a length of about 20-100 mm, and has a thickness of about 30-400 μm. In this specific example, the package has a substantially rectangular shape in which a first side has a length of about 25-130 mm and a second side has a length of about 25-130 mm. In this specific example, the first region of the package has a substantially rectangular shape in which a first side has a length of about 21-110 mm and a second side has a length of about 21-110 mm. In this specific example, the second region of the package has a strip shape having a width of about 2-10 mm. In this specific example, the first region projects to a height of about 0.5-2.0 mm from the second region.
In the next place,
Techniques for obtaining the sealed region 11 are not particularly limited so long as the first sheet material and the second sheet material can be sealed to each other. For example, fusion bonding such as heat sealing or adhesive bonding can be used to obtain the sealed region 11. On the other hand, in the unsealed region 12, the first sheet material and the second sheet material are not sealed to each other. The first and second sheet materials may be in contact with each other or apart from each other, and need not be in close contact with each other. It is preferred that in the unsealed region, the first sheet material and the second sheet material are in close contact with each other to form one or more close-contact regions. Although the unsealed region in
With Reference to
The close-contact region 14 need not be a region where the first sheet material has been sealed to the second sheet material, so long as the first and second sheet materials are sufficiently near to each other. In the close-contact region, the distance between the inner wall of the first sheet material and the inner wall of the second sheet material is shorter than the thickness of the patch 3. Owing to this close-contact region, a peripheral part of the patch is inhibited from being caught in the gap between the first sheet material and second sheet material even when the patch moves in the package. Because of this, the possibility that the patch might be torn together with the package upon opening is reduced. Techniques for obtaining the close-contact region are not particularly limited. Examples thereof include a method in which the first sheet material and/or the second sheet material in the region are slightly projected toward each other. In this embodiment, the close-contact region 14 has been drawn so as to have an elliptic planar shape. However, the planar shape of the close-contact region 14 should not be construed as being limited to elliptic ones. Other examples thereof will be described later.
In the next place, reference is made to
In this embodiment, the package has one or more opening initiation parts 16 in a peripheral area of the package. The opening initiation part 16 in this embodiment has been drawn as a substantially V-shaped notch in the package. The planar shape of the notch should not be construed as being limited to that shape, and may be a substantially quadrangular shape such as a substantial I-shape or a substantially trapezoidal shape or a substantially polygonal shape such as a substantially pentagonal shape. This constitution enables the user to easily tear the package at the opening initiation part 16. The opening initiation part is disposed so as to result in a tear 13 extending to the unsealed region 12.
The direction in which a tear is to be formed is governed by the planar shape of the notch. For example, in the case of a substantially V-shaped notch, a tear will be formed along the extension of a straight line which nearly bisects the V-shaped vertex angle, unless the user tears the package with special intention. Alternatively, in the case of a substantially I-shaped notch, a tear will be likewise formed along the extension of the shape I. Consequently, a notch is disposed in such a position that the unsealed region is present on such an extension of the straight line. In addition, the shape of the tear to be formed can be shown as an illustration on the outer wall of the package, or how to tear the package can be described in the directions to be attached to the patch package structure.
In this embodiment, the second sealed regions 15 have a dot-form planar shape.
It is preferred in the invention that the planar outer shape of each second sealed region 15 is small. For example, in the case where the strip-form unsealed region 12 is split into a package-center-side half and a package-periphery-side half, the planar outer shape of each second sealed region 15 is included in the package-center-side half. When the user tears the package to form a tear 13, a lower force suffices for the user to tear the region which has not been sealed (i.e., the unsealed region 12) than in the case of tearing the region which have been sealed (i.e., the second sealed region 15). Consequently, the second sealed region 15 having a small planar outer shape is preferred because the user can easily form a tear in the package.
Furthermore, in the case that the user tears the package to form a tear 13 and the user then peels off the first and second sheet materials in the second sealed region 15 in the resultant opening, a lower peeling force suffices when the second sealed region 15 has a smaller area. The dot-form second sealed region 15 is preferred from the standpoint of ease of production.
This constitution has the following advantage when the package is torn at the opening initiation part 16 to form a tear 13 and open the package. Namely, the first sheet material and the second sheet material can be easily peeled off from an area around the vertex located between the first side and second side of the substantially rectangular boundary between the first region 9 and the second region 10.
With reference to
The first sheet material and second sheet material in the patch package structure of the invention described above are not particularly limited so long as both materials can be sealed together for forming the package. Heat-sealable sheet materials are preferred from the standpoint of ease of production. Examples of such packaging materials include films of resins such as polyolefins including polyethylene and polypropylene, polyesters including poly(ethylene terephthalate), and other resins including poly(vinyl chloride) and polyacrylonitrile, metal films such as aluminum foils, materials obtained by vapor-depositing aluminum on these films, and laminated films obtained by laminating two or more thereof.
From the standpoints of impermeability to package contents such as a drug and heat sealability, a polyacrylonitrile film or the like is preferred for use as such a packaging material. From the standpoint of the property of not adsorbing package contents such as a drug, it is preferred to employ a polyester, in particular, poly(ethylene terephthalate) or the like. From the standpoint of the property of being impermeable to or not transmitting package contents (components of the patch and the gas in the package), light rays, or gases, more preferred packaging materials are those resin films which have undergone aluminum vapor deposition and laminated films obtained by laminating an aluminum foil to those resin films. More preferred from the standpoint of reconciling those properties are laminated films obtained by laminating a polyester, in particular poly(ethylene terephthalate), with a polyacrylonitrile film. Most preferred is a laminated film obtained by laminating a polyester, in particular poly(ethylene terephthalate), with an aluminum foil or vapor-deposited aluminum layer and a polyacrylonitrile film. From the standpoint of the storage stability of package contents such as a drug, a laminated film obtained by laminating a water-impermeable layer and a water-permeable layer respectively to the outer side and inner side of a hygroscopic layer containing a drying agent is also preferred.
Materials and constitutions of the first sheet material and the second sheet material may be the same or different. In the case where the second sheet material to be used is a molded sheet material, it is preferably made of a rigid material because the molded sheet material is required to retain a given shape. In the case where the first sheet material is used as an approximately planar unmolded sheet material without being molded, the first sheet material is preferably made of a flexible material because such unmolded sheet material can be easily sealed to the second sheet material to thereby facilitate production.
The thickness of the first sheet material is not particularly limited. However, it is preferably 10-200 μm, more preferably 20-100 μm, from the standpoints of production efficiency and impermeability to ingredients to be packaged in the package structure.
The thickness of the second sheet material is not particularly limited. It is, however, preferred that the second sheet material have some degree of stiffness because of the necessity of retaining the given shape. From this standpoint, the thickness thereof is preferably 50-300 μm, more preferably 50-200 μm.
Molding methods for obtaining the molded sheet material having the given shape are not limited. Examples thereof include vacuum/pressure molding, injection molding, and press molding. From the standpoints of suitability for cost reduction, degree of freedom of shapes, material selection, etc., vacuum molding, pressure molding, and the like are preferred.
The patch may be a patch preparation in which the pressure-sensitive adhesive layer contains a drug. The drug herein is not particularly limited. Preferred is a drug which can be administered to a mammal such as a human being through the skin, i.e., which is percutaneously absorbable. Examples of such drugs include systemic anesthetics, hypnotic agents, antiepileptics, antipyretic/analgesic/antiphlogistic agents, antidizzying agents, psychoneurotics, local anesthetics, skeletal muscle relaxants, agents for autonomous nerve, antispasmodics, anti-Parkinsonian agents, antihistamines, cardiotonics, antiarrhythmics, diuretics, antihypertensives, vasoconstrictors, coronary vasodilators, peripheral vasodilators, antiarteriosclerotic agents, agents for circulatory organs, respiration facilitators, antitussive/expectorant agents, hormone drugs, external-use preparations for purulent diseases, analgesic/antipruritic/astringent/antiphlogistic agents, agents for parasitic skin diseases, hemostats, antipodagrics, agents for diabetes, antineoplastics, antibiotics, chemotherapeutics, narcotics, and smoking renunciation aids.
The content of the percutaneously absorbable drug is not particularly limited so long as it sufficiently produces the effect thereof and does not impair the adhesiveness of the pressure-sensitive adhesive. However, the content thereof in the pressure-sensitive adhesive is, for example, 0.01-70% by weight, preferably 0.1-60% by weight, more preferably 0.5-40% by weight. In case where the content thereof is lower than 0.01% by weight, there is a possibility that the remedial effect might be insufficient. In case where the content thereof is higher than 70% by weight, there is a possibility that skin irritation might occur and such a large drug amount might be economically disadvantageous.
The pressure-sensitive adhesive layer contains a pressure-sensitive adhesive. The pressure-sensitive adhesive is not particularly limited. Examples thereof include acrylic pressure-sensitive adhesives containing an acrylic polymer; rubber pressure-sensitive adhesives such as styrene/diene/styrene block copolymers (e.g., styrene/isoprene/styrene block copolymers and styrene/butadiene/styrene block copolymers), polyisoprene, polyisobutylene, and polybutadiene; silicone pressure-sensitive adhesives such as silicone rubbers, dimethylsiloxane-based polymers, and diphenylsiloxane-based polymers; vinyl ether pressure-sensitive adhesives such as poly(vinyl methyl ether), poly(vinyl ethyl ether), and poly(vinyl isobutyl ether); vinyl ester pressure-sensitive adhesives such as vinyl acetate/ethylene copolymers; and polyester pressure-sensitive adhesives produced from a carboxylic acid ingredient such as dimethyl terephthalate, dimethyl isophthalate, or dimethyl phthalate and a polyhydric alcohol ingredient such as ethylene glycol.
Acrylic pressure-sensitive adhesives or rubber pressure-sensitive adhesives are preferred among such pressure-sensitive adhesives because acrylic or rubber pressure-sensitive adhesives give a pressure-sensitive adhesive layer which is capable of holding a liquid component therein and hence can give a soft feeling during wear on the skin. In particular, acrylic pressure-sensitive adhesives are preferred because they can be easily crosslinked and give a pressure-sensitive adhesive layer capable of holding a large amount of a liquid component therein.
Examples of such acrylic pressure-sensitive adhesives include acrylic ester pressure-sensitive adhesives containing as the main component a polymer comprising monomer units derived from one or more C2-18 alkyl esters of (meth)acrylic acid. Examples of those rubber pressure-sensitive adhesives include rubber pressure-sensitive adhesives containing as the main component at least one member selected from polyisobutylene, polyisoprene, and styrene/diene/styrene copolymers.
The liquid component is not particularly limited. From the standpoint of compatibility with the pressure-sensitive adhesive layer, organic liquid ingredients are preferred. Although the organic liquid ingredients are not particularly limited, ones having the effect of accelerating percutaneous absorption are preferred. Examples of such organic liquid ingredients include glycols such as ethylene glycol, diethylene glycol, propylene glycol, triethylene glycol, polyethylene glycol, and polypropylene glycol; fats and oils such as olive oil, caster oil, squalane, and lanolin; hydrocarbons such as liquid paraffin; various surfactants; ethoxy stearyl alcohol; glycerol monoesters such as oleic acid monoglyceride, caprylic acid monoglyceride, and lauric acid monoglyceride, glycerol diesters, glycerol triesters, and mixtures thereof; alkyl esters of fatty acids, such as ethyl laurate, isopropyl myristate, isotridecyl myristate, octyl palmitate, isopropyl palmitate, ethyl oleate, and diisopropyl adipate; higher fatty acids such as oleic acid and caprylic acid; and other compounds including N-methylpyrrolidone and 1,3-butanediol.
In the case where a liquid component is contained in the pressure-sensitive adhesive layer, there is a possibility that during storage of the patch, the pressure-sensitive adhesive layer might plasticize and components of the pressure-sensitive adhesive layer might protrude or flow out from the periphery of the patch. The invention is advantageously practiced especially in such cases. From this standpoint, the content of the liquid component in the pressure-sensitive adhesive layer is preferably 5-70% by weight, more preferably 10-65% by weight, most preferably 15-60% by weight.
When the pressure-sensitive adhesive layer is relatively thick, the protrusion or outflow of the pressure-sensitive adhesive layer from the periphery of the patch tends to occur. The invention is advantageously practiced especially in such cases. From this standpoint, the thickness of this pressure-sensitive adhesive layer is preferably 20-300 μm, more preferably 30-250 μm, most preferably 50-200 μm.
The explanations of the invention given above are merely illustrative, and modified embodiments thereof which do not depart from the spirit of the invention are hence intended to be within the scope of the invention. Such modified embodiments should not be construed ad departing from the spirit and scope of the invention.
The present application is based on Japanese Patent Application No. 2008-026631 filed on Feb. 6, 2008, and the contents are incorporated herein by reference.
Number | Date | Country | Kind |
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2008-026631 | Feb 2008 | JP | national |