JP4549732B2 - Packing bag for storing patch and patch package - Google Patents

Description

  TECHNICAL FIELD The present invention relates to a patch storage packaging bag and a patch package, and more particularly, to a patch storage packaging bag excellent in usability in which the patch can be easily taken out, and to the package. It is related with the patch package body which was excellent in the handleability which accommodates.

BACKGROUND ART Drug-containing patches for administering a drug into a living body by percutaneous absorption are widely used in various fields because they can be gradually released into the living body over time by being applied to a local area. Such drug-containing patches are made of plastics such as polyester and polyethylene, or a patch layer containing a transdermally absorbable drug is formed on the surface of a base material such as a woven fabric or non-woven fabric that has been subjected to a drug-impermeable treatment. The release layer is laminated on the surface of the adhesive layer to protect the surface of the adhesive layer. Usually, such a patch is stored in a packaging bag made of a drug-impermeable sheet in order to prevent deterioration of the contained drug due to volatilization or environmental influence.
When the patch is packaged in a packaging bag, the components of the patch layer containing the drug, such as the patch layer composition itself, the plasticizer contained in the patch composition, the tackifier, etc. The adhesive sticks to the inner surface of the sheet constituting the packaging bag or the back surface of the base material and protrudes from the end surface, and it may be difficult to remove the patch from the packaging bag during use.

As a method for solving these problems, for example, the release paper is sufficiently large compared to the adhesive layer, and the components leached from the adhesive layer are stopped on the release paper, or the release paper is made with the outer peripheral edge of the release paper as the edge height. Although it is possible to prevent leaching of components to the outside, in any case, it is necessary to consider the fact that an extra release paper material is required and a separate process called release paper molding is required. In this case, there is a problem from the viewpoint of cost and manufacturing process.
On the other hand, improvement of the packaging bag is also being studied, and a method has been proposed in which irregularities are formed on the inner surface of the packaging sheet, thereby reducing the contact area with the inclusion and suppressing unwanted adhesion. (For example, refer to Patent Document 1). In this method, when unevenness is formed on the sheet itself by uneven roll processing, the effect is reduced by unevenness being deformed and smoothed by stress, and there is a concern that holes or scratches may be formed in the sheet during formation. In the case where irregularities are formed using an ink formed of a foamable resin, there is a problem that the process becomes complicated. Moreover, in any case, there is a concern that the effect of preventing the volatilization of the medicine in the adhesive layer due to the decrease in adhesiveness at the peripheral edge of the packaging bag due to the unevenness.
Japanese Patent Laid-Open No. 7-80040

  The present invention has been made in order to solve such problems, and an object of the present invention is to achieve high sealing performance of the seal portion, and to effectively suppress the volatilization of the drug contained in the patch, and to package it. When removing the patch from the bag, a patch bag for storing the patch that can be quickly removed without peeling off the release paper, and a patch package with excellent handleability by storing the patch in the package It is to provide.

The packaging bag for storing a patch of the present invention comprises a pair of sheets having a heat-fusible resin layer for storing a patch formed by laminating a patch layer containing a drug and a release paper on a base material. A packaging bag configured by heat-sealing, wherein at least part of the heat-sealing portion of the packaging bag is configured by directly heat-sealing the heat-sealing resin layers of the sheet; A part of the inner surface of the sheet is provided with an adhesion preventing layer made of a release agent , where A is the width of the heat fusion part at the periphery of the sheet, and B is the width of the part where the heat fusion part and the adhesion prevention layer overlap. 0 or where, B / a is characterized scope der Rukoto of 1 / 10-5 / 10.
In this patch storing packaging bag, the adhesion preventing layer extends to the heat fusion part of the packaging bag, the outer periphery of the adhesion preventing layer is outside the inner circumference of the heat fusion part , When the width of the heat-sealed part is A and the width of the part where the heat-fused part and the adhesion preventing layer overlap is B, both of them are partly so that B / A is in the range of 1/10 to 5/10. and overlap Turkey from the viewpoint of sealing properties and anti-adhesion properties.
Furthermore, when the adhesion preventing layer is colored, there is an advantage that alignment becomes easy when heat-sealing the pair of sheets.
The sheet constituting the packaging bag used here has a laminated structure, and at least one of the plurality of layers, in particular, the innermost layer is a drug non-absorbable layer. It is preferable from the viewpoint of preventing adsorption. A non-adsorbing resin that can form an adsorbing drug non-absorbing layer that does not have a concern of reducing the effect of the patch by adsorbing medicinal ingredients, and used as the innermost layer of the packaging bag, such as norbornene resin A cyclic polyolefin resin can be mentioned. Although the cyclic polyolefin resin may be difficult to heat-seal, by using it in the embodiment as in the present invention, the drug non-adsorbability and the adhesiveness are compatible, and the effects of the present invention can be exhibited.

The patch package according to claim 5 of the present invention is a patch obtained by laminating a patch layer containing a drug and a release paper on a base material in any one of the above-described packaging bags for storing a patch of the present invention. It is characterized by containing an agent.
Here, it is preferable from the viewpoint of the effect that the peel force between the adhesion preventing layer and the adhesive layer in the packaging bag for storing a patch is equal to or less than the peel force between the adhesive layer and the release paper.
The adhesion preventing layer provided on the inner surface of the sheet is easily formed by applying a release agent to the inner surface of the sheet. Although the adhesion preventing layer may be provided only on one side of the sheet, it is preferably provided on the inner surfaces of both sides from the viewpoint of the effect.

According to the aspect of the present invention, the sheet constituting the packaging bag is smooth and excellent in adhesiveness, and excellent airtightness is achieved, and when the adhesion preventing layer is provided on a part of the sheet inner surface, By extending the outer periphery to the heat-sealed part of the pair of sheets and overlapping the parts, the effect of reaching the corners inside the packaging bag is obtained without impairing the heat-sealing property of the peripheral part. Anti-adhesive properties can be obtained.
Further, in a preferred embodiment, the peel force of the adhesion preventing layer provided on the inner surface is optimized in the relationship between the adhesive layer and the release paper, so that the adhesive layer does not peel from the release paper, Adhesion with the inner surface of the packaging bag is effectively suppressed, and it can be easily removed from the packaging bag when the patch is used.

  According to the present invention, the sealing part has high sealing performance, and effectively suppresses the volatilization of the drug contained in the patch, and when the patch is taken out from the packaging bag, the release paper is not peeled off quickly. It is possible to provide a patch storage packaging bag that can be taken out, and a patch package that is excellent in handleability using the same.

Hereinafter, the present invention will be described in detail.
FIG. 1 is a perspective view showing a patch storing packaging bag (hereinafter, appropriately referred to as a packaging bag) 10 of the present invention. The packaging bag 10 is formed by heat-sealing the peripheral portions of a pair of sheets 12 arranged facing each other. An adhesion preventing layer 14 is provided on a part of the inner surface of the sheet 12 constituting the packaging bag.

  In FIG. 1, the pair of sheets arranged to face each other is composed of two sheets, but it is not always necessary to have two sheets. The two sheets are opposed to each other by folding one rectangular sheet into two. In this case, if the airtightness can be secured, the fold portion may be heat-sealed or not heat-sealed. The sheet constituting the packaging bag is preferably a gas-impermeable sheet from the viewpoint of suppressing the volatilization of the drug contained in the encapsulated patch, as long as the sheet has a heat-fusible resin layer. Even if it is a single layer, it may have a laminated structure formed by laminating a plurality of layers, but those having a laminated structure formed by laminating a plurality of layers having different functions are preferable from the viewpoint of effect. .

  A typical example of the gas-impermeable sheet is a synthetic resin film. Among them, a sheet that can be heat-sealed is preferable from the viewpoint of simplicity of the manufacturing process and sealing reliability. Specific examples of such synthetic resins include olefin resins such as polyethylene, polypropylene, and polybutylene, ethylene-vinyl acetate copolymers, and ethylene-vinyl alcohol copolymers.

A synthetic resin film can exhibit gas barrier properties even with a single layer by selecting the material and thickness. In this case, a single layer sheet can be used, but it will be described in detail later, but it is used for a patch. Because many chemicals are low-molecular compounds that easily volatilize, in order to obtain higher gas barrier properties, laminated metal foils, etc., synthesis of polyacrylonitrile, polyester, cyclic polyolefin, polyvinyl alcohol, ethylene-vinyl alcohol copolymer, etc. It is preferable to laminate a non-drug-adsorbing layer made of a resin sheet.
Further, for the purpose of improving printability and strength, paper or a biaxially stretched film may be laminated on the outermost layer. In this case, these materials may be gas permeable.
Although the thickness of the sheet | seat which comprises a packaging bag can be selected according to the objective, Generally, about 10-150 micrometers is preferable at a single layer sheet | seat, and 10-250 micrometers is the whole thickness at a laminated sheet.

In order to form the packaging bag of the present invention, a pair of sheets are arranged facing each other, the opening is left at the upper end, the side end and the lower end are heat-sealed, and then the patch from the opening And the opening may be heat-sealed. Further, as described above, when one sheet is folded in two, the portion corresponding to the fold mountain does not necessarily have to be heat-sealed. When two sheets are used, it is not always necessary to have the same material and configuration.
The pair of sheets is easily sealed by overlapping the heat-fusible resin layers provided on the inner surface of the sheets and heat-sealing them by a known method such as thermocompression bonding.

The packaging bag of this invention is equipped with the adhesion prevention layer which consists of release agents in a part of sheet | seat inner surface. The adhesion preventing layer is preferably formed by applying a release agent to the inner surface of the sheet and drying it from the viewpoint of simplicity of the process.
The adhesion preventing layer may be provided only on the inner surface of one of the sheets. For example, when the release paper of the patch is larger than the size of the patch, the effect of the present invention can be obtained by providing it only on the base sheet side, but it is generally provided on the inner surfaces of the sheets on both sides. Is preferred.

  In addition, it is preferable to use a coloring agent as the release agent because the formation region of the adhesion preventing layer is easily visible, and alignment is facilitated when heat-sealing a pair of sheets. As the colorant used for coloring the adhesion preventing layer, known colorants can be appropriately selected and used, but those having excellent affinity with the release agent and dispersibility are preferred, from such a viewpoint, For example, phthalocyanine blue is preferable.

When the adhesion preventing layer is formed of a release agent, examples of the release agent that can be used include Toray Dow Corning, LTC-305B (trade name), GE Toshiba Silicone, TPR-6500 (trade name), and the like. . The adhesion preventing layer can be formed by dissolving these in an appropriate solvent such as ethyl acetate or toluene, applying the solution to a predetermined region on the surface of the sheet, and curing with hot air or ultraviolet rays. The coating amount is appropriately selected depending on the required peeling force and the physical properties of the sheet to be formed. In general, the coating amount after drying is preferably 0.1 to 5 g / m ² , More preferably, it is 0.5 g / m ² .

The adhesion preventing layer is formed on a part of the inner surface of the sheet constituting the packaging bag. The adhesion preventing layer can be formed in a desired region as long as the heat fusion property of the heat fusion region formed on the peripheral edge of the sheet is not impaired. Specific examples of the adhesion preventing layer forming region are shown in FIG. 3 to FIG. 6 by model diagrams, but the present invention is not limited to these. In the figure, the region indicated by the hatched portion represents the adhesion preventing layer forming portion 14, and the region indicated by the halftone dot represents the heat fusion region 16.
Here, when the width of the heat fusion region at the peripheral edge of the sheet is A and the width of the portion where the heat fusion region and the adhesion preventing layer overlap is B, in this embodiment, there is no overlapping portion, and B is 0.
FIG. 2A shows an embodiment in which the adhesion preventing layer 14 is formed in the entire region except for the heat fusion region 16 at the periphery of the sheet 12. In addition, since adhesion or adhesion between the patch, which is an article to be stored, and the packaging bag, mainly occurs due to the exudation of the adhesive layer component from the edge of the patch, it occurs in the vicinity of the peripheral edge of the sheet. ), The same effect can be obtained without providing the adhesion preventing layer 14 at the center of the sheet.
Here, even if a slight gap is generated between the heat fusion region 16 and the adhesion preventing layer 14, there is no problem as long as the end portion of the patch does not enter there.

  3 and 4 are model diagrams showing a preferred embodiment of the region where the adhesion preventing layer 14 is formed. 3 and 4, the adhesion preventing layer 14 is extended to the heat fusion region 16 at the periphery of the sheet, and the adhesion preventing layer 14 region and the heat fusion region 16 partially overlap each other. In this aspect, it is possible to obtain a packaging bag having a high adhesion suppressing effect at the end of the packaging bag and excellent in airtightness, which is preferable. At this time, when the width of the heat fusion region at the periphery of the sheet is A and the width of the portion where the heat fusion region and the adhesion preventing layer overlap is B, B / A is in the range of 1/10 to 5/10. It is preferable that it is in the range of 1/10 to 2/10.

  The packaging bag is not necessarily rectangular, and may be elliptical as shown in the model diagram of FIG. Further, the region where the heat-sealed portion is not formed at the center of the sheet may not be rectangular as shown in FIG. 2B or FIG. 4, and may be any shape such as a heart shape shown in FIG. By selecting a highly designable shape as this shape and forming the adhesion preventing layer with a coloring material, there is also an advantage that the appearance can be improved. At this time, the design effect can be improved by selecting a transparent or translucent material as the sheet.

In the patch package of the present invention, the peeling force of the adhesion preventing layer is selected based on the balance between the peeling force between the adhesive layer and the peeling force between the adhesive layer and the release paper in the stored patch. It is preferable to adjust so that the peeling force is equal to or less than the latter peeling force. Here, “below” means that it can be peeled off with a smaller force.
The adhesion preventing layer is provided for the purpose of suppressing the adhesion of the adhesive layer component of the patch, but when evaluating peel strength, the adhesion preventing layer formed on the adhesive layer and the inner surface of the sheet constituting the packaging bag Are then peeled off under predetermined conditions, and the peel force at that time is measured.
Moreover, what is necessary is just to measure the peeling force of the sticking layer of a patch, and release paper by using the patch itself as a sample and peeling force of a sticking layer and release paper.

Usually, in the present invention, the peel force defined in the claims is evaluated by measuring the peel strength of the adhesion preventing layer to the adhesive layer and the release paper to the adhesive layer, and comparing the respective peel forces. However, since the adhesive layer that serves as a reference for the peel force in the above measurement is common, the values measured under the same conditions using the same adhesive tape as a sample are relatively compared as shown below. Thus, it can be confirmed whether or not the relationship of each peeling force is included in the preferable range of the present invention.
[Peeling force]
First, a polyester pressure-sensitive adhesive tape No. 1 was formed on the surface of the adhesion preventing layer. Adhesive surfaces of 31B (manufactured by Nitto Denko Corporation) are bonded together, and heat-treated at 70 ° C. for 20 hours under a load of 20 g / cm ² . This is subjected to a tensile tester, and the resistance value when the polyester adhesive tape is peeled from the adhesion preventing layer at an angle of 180 ° and a speed of 0.3 m / min is defined as a first peeling force. Next, the same polyester adhesive tape No. 31B is bonded together and the same operation is performed, and the second peeling force is measured. It is a preferred embodiment of the patch package of the present invention that the first peel force is equal to or less than the second peel force.

As a method for adjusting the peel force, first, the peel force between the adhesive layer and the release paper in the patch that is an article to be stored is measured directly or by the method described above. Next, the peeling force between the adhesive layer and the adhesion preventing layer provided inside the packaging bag is measured, and the peeling force between the adhesion preventing layer and the adhesion layer provided inside the packaging bag is equal to the previously measured value or What is necessary is just to adjust the physical property of an adhesion prevention layer so that it may become below that.
The peel strengths of the two may be equal, but from the viewpoint of the effect, it is preferably less than about 20% ((first peel force / second peel force) = (8/10) or less), preferably 50% It is more preferable that it is less than [(first peel force / second peel force) = (5/10) or less].
Adjustment of the peeling force of the adhesion preventing layer can be easily performed by a known method such as changing the type and amount of the release agent used or adding a light release agent.
Preferred embodiments of the release agent used in the present invention include (1) organic release agents such as olefin resins and long chain alkyl group-containing resins, (2) silicone release agents, and (3) silicone release agents and organics. Examples thereof include blends with copolymers, copolymers, (4) fluorine release agents, (5) blends of fluorine release agents with other release agents, copolymers, and the like.
Thus, the packaging bag which has the above outstanding characteristics can be obtained by adjusting the peeling force of an adhesion prevention layer in relation to the patch accommodated inside a packaging bag.

Next, the patch contained in the packaging bag of the present invention will be described.
The drug-containing patch that can be applied to the packaging bag of the present invention forms a patch layer containing a transdermally absorbable drug on the surface of the base material, and laminates release paper on the patch layer surface to form the patch layer surface. Any protective material can be used without particular limitation.
Substrates include polyolefins such as polyethylene and polypropylene; polyesters such as polyethylene terephthalate; plastic sheets such as polyacrylonitrile; stretchable elastomer and rubber sheets, metal foil, and surface impregnated with drugs. A woven fabric, a non-woven fabric, or a composite sheet thereof can be used.

  The patch layer contains a known transdermally absorbable drug that can penetrate into the body through the skin as a medicinal component. Representative examples of the drug include blood circulation promoters such as l-menthol and camphor, analgesics such as indomethacin, and transdermal penetration enhancers such as urea, but are not limited thereto. The drug can be used alone or in combination of two or more depending on the purpose of the patch.

These agents are contained in an adhesive organic material mainly composed of a polymer such as an acrylic, rubber, silicone, or vinyl ether, and an adhesive layer using the organic material as a matrix is formed. A plasticizer, a tackifier, etc. can be mix | blended with the composition which forms this sticking layer as needed.
Since the surface of the drug-containing adhesive layer formed on the substrate has adhesiveness, it is protected by laminating release paper until use.
As the release paper, a known release paper such as a resin film such as a polyethylene terephthalate (PET) film, a metal foil, paper, or a laminate of these can be arbitrarily selected and used. .

  The packaging bag and patch package of the present invention have high hermeticity, can effectively prevent the volatilization of the drug in the patch that is the object to be stored, and is easy to take out the patch. Also, it can be suitably used for a patch containing a fragrance as a medicine, and its application range is wide.

Hereinafter, the present invention will be described in detail using specific examples, but the present invention is not limited thereto.
Example 1
A synthetic resin film 12 made of a laminate of a PET film having a width of 50 mm and a length of 50 mm and a thickness of 12 μm and a polyacrylonitrile non-absorbable layer made of polyacrylonitrile having a thickness of 30 μm was used as a sheet for constituting a packaging bag.
A silicone release agent (manufactured by Toray Dow Silicone Co., Ltd., LTC-350B) is applied to the inner surface (polyacrylonitrile layer) of the film so that the applied amount after drying is 1 g / m ^{2 in} the shape shown in FIG. It dried and the adhesion prevention layer was formed. Thereafter, the lower end and both side portions were heat-sealed, and one patch was introduced from the opening at the upper end, and the upper end was heat-sealed to obtain a packaging bag for storing a patch.
The patch applied here uses a non-woven fabric as a base material, and a patch layer made of a rubber-based adhesive layer containing indomethacin as a drug is formed on the surface so as to have a thickness of 50 μm, and a release paper (PET) is formed on the surface. The film is formed by laminating the same release agent as that having formed the adhesion preventing layer on the film in the same amount and drying.

(Measurement of peel force)
The following peeling force was measured by the measurement method based on a commercially available adhesive tape.
The peel force between the reference adhesive tape and release paper was measured at 10 points, and as a result, it was 10 to 12 g (10 to 12 g / 50 mm) for a sample having a width of 50 mm. Moreover, the peeling force between the adhesive tape and the adhesion preventing layer formed on the inner surface of the sheet is 10 to 12 g / 50 mm, and the peeling force between the adhesion preventing layer and the adhesive layer is equivalent to the peeling force between the adhesive layer and the release paper. It was confirmed that.

(Evaluation of ease of removal)
After preparing 10 of these packaging bags and leaving them in an oven at a temperature of 40 ° C. for 30 days, the packaging bag was opened and the patch inside was taken out. There was no adhesion between the material to be stored and the inner surface of the packaging bag sheet due to the seepage of.
(Evaluation of sealing performance)
In addition, even after storage under the same conditions, no peeling or opening of the heat-sealed portion at the periphery of the packaging bag was observed, and there was no change in the medicinal properties and effects of the encapsulated patch. Was confirmed to be excellent in hermeticity.

It is a perspective view which shows an example of the packaging bag of this invention. It is a model figure which shows the shape of the adhesion prevention layer provided in the sheet | seat inner surface which comprises a packaging bag, (A) shows the aspect provided in the whole surface except the adhesion | attachment area | region, (B) is adhesion prevention in a sheet | seat center part. The mode which does not provide a layer is shown. It is a model figure which shows the aspect in which the adhesion prevention layer provided in the sheet | seat inner surface which comprises a packaging bag partially overlaps with the adhesion area | region of a peripheral part. It is a model figure which shows another aspect in which the adhesion prevention layer provided in the sheet | seat inner surface which comprises a packaging bag partially overlaps with the adhesion area | region of a peripheral part. It is a model figure which shows the shape of the adhesion prevention layer provided in the sheet | seat inner surface in the elliptical packaging bag. It is a model figure in which the unformed area of the adhesion preventing layer provided on the inner surface of the sheet shows the shape of a heart.

Explanation of symbols

10 Packaging bags for storing patches (packaging bags)
12 Sheet 14 constituting the packaging bag Adhesion prevention layer 16 Thermal fusion region of the sheet constituting the packaging bag

Claims (5)

A packaging bag configured by heat-sealing a pair of sheets having a heat-fusible resin layer for storing a patch formed by laminating a patch layer containing a drug and a release paper on a base material There,
At least a part of the heat-sealing part of the packaging bag is formed by directly heat-sealing the heat-sealing resin layers of the sheet, and an adhesion preventing layer made of a release agent is formed on a part of the inner surface of the sheet. And B is 0 or B / A is 1/10, where A is the width of the heat-sealed portion at the periphery of the sheet and B is the width of the portion where the heat-fused portion and the adhesion preventing layer overlap. 5/10 patch accommodating packaging bag, wherein the range der Rukoto of. The packaging bag for storing patches according to claim 1, wherein the adhesion preventing layer is colored. The patch-containing packaging bag according to claim 1 or 2 , wherein the sheet constituting the packaging bag has a laminated structure, and at least one layer thereof is a drug non-absorbable layer. A patch comprising a patch containing a patch and a release paper laminated on a base material in the patch storage packaging bag according to any one of claims 1 to 3. Agent package. The patch package according to claim 4 , wherein the peel force between the adhesion preventing layer and the adhesive layer in the adhesive packaging packaging bag is equal to or less than the peel force between the adhesive layer and the release paper.

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