JP2019038615A - Carrying drug set - Google Patents

Abstract

To provide a packaging form which suppresses decomposition of a drug due to humidity and has improved drug stability during long-term storage, when achieving a portable package in which a PTP sheet is mounted on a portable protective case.SOLUTION: There are provided a PTP sheet in which tablets containing at least one steroid hormone as an active ingredient are divided and stored; a portable protective case which has the PTP sheet mounted therein and forms a portable package; and a portable drug set which has a container for housing the PTP sheet and the portable protective case and in which the portable protective case is formed of a paper mount and the PTP sheet is stored in an outer bag of a gas barrier material and is packaged separately from the portable protective case in the container.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a portable drug set useful for providing a portable package in which a PTP sheet is attached to a portable protective case.

  2. Description of the Related Art Conventionally, a PTP sheet that is an embodiment of a press-through pack package (hereinafter also referred to as “PTP package”) is known as a medicine packaging form. As this type of PTP sheet, a plurality of pockets that bulge to one side of a transparent base sheet are thermoformed, each of the drugs is stored in the pockets, and a metal foil or the like is opened in the pockets. What sealed and stuck the breakable cover film is generally known. In this PTP sheet, the medicine stored in the pocket portion is taken out by pressing the swollen pocket portion with a finger toward the lid film and breaking the lid film.

  On the other hand, in order to easily carry the PTP sheet, a holding case or a protective case for mounting the PTP sheet has been proposed (see Patent Documents 1 and 2). In these cases, information such as usage / dose, efficacy / effects, precautions for use, etc. is described in the case itself, which not only improves portability, which is its original purpose, but also improves compliance. Expected to be useful. For example, as a product form of a low-dose pill, a portable package in which a PTP sheet is attached to a paper protective case has already been commercialized, and a product packaged with a material such as a biaxially stretched polypropylene film is provided in this portable package. It is distributed in the market.

Japanese Patent Laid-Open No. 2003-237836 JP 2012-066836 A

  A drug containing a steroid hormone as an active ingredient, particularly a tablet, may undergo slight degradation over time due to the influence of humidity (moisture). Therefore, in adopting the above-described carrying package, there is a demand for a packaging form that suppresses drug degradation due to humidity and further enhances drug stability during long-term storage. However, it is difficult to say that a product packaged with a material such as a biaxially stretched polypropylene film is sufficient to suppress the entry of moisture (moisture) from the outside.

  In recent years, in various packaging fields, the use of an outer bag made of a gas barrier material having excellent physical properties such as low oxygen permeability and moisture resistance has been studied. Therefore, instead of packaging films such as the above-mentioned biaxially stretched polypropylene film, the carrying package is wrapped with an outer bag made of a gas barrier material, thereby preventing the invasion of oxygen and humidity from the outside, thereby long-term stability of the drug. However, it was found that suppression of drug degradation is not always achieved.

  The present invention has been made in view of such circumstances, and the purpose thereof is to realize a portable package in which a PTP sheet is attached to a portable protective case, and drug decomposition due to humidity is suppressed, and during long-term storage. The object is to provide a packaging form with enhanced drug stability.

  As a result of intensive studies on the above problems, the present inventor has the possibility that drug decomposition may be accelerated if a carrying package in which a PTP sheet is attached to a carrying protective case is enclosed in an outer bag made of a gas barrier material. Furthermore, the present inventors have completed the present invention by ascertaining the cause of such enhanced drug degradation.

That is, the present invention provides the following aspects <1> to <5>.
<1> A PTP sheet in which tablets containing at least one steroid hormone as an active ingredient are stored separately, a protective case for carrying the PTP sheet to form a carrying package, and the PTP sheet and carrying A protective case for carrying, the protective case for carrying is made of a paper mount on which information about the active ingredient and the tablet is printed, and the PTP sheet is contained in an outer bag of a gas barrier material In the container, the PTP sheet is packaged separately from the carrying protective case, and is not affected by moisture contained in the paper mount, and is stored for a long time. A portable drug set in which the stability of the active ingredient at the time is further enhanced.
<2> The portable drug set according to <1>, wherein the PTP sheet is housed in the outer bag together with a desiccant.
<3> The portable drug set according to <1> or <2>, wherein the steroid hormone is follicular hormone or follicular hormone and another steroid hormone.
<4> The drug set for carrying according to any one of <1> to <3>, wherein at least one of the PTP sheet and the carrying protective case is accommodated in the container. <5> The portable protective case includes a plurality of folded paper mounts, and the paper mount includes a mounting portion to which the PTP sheet is fixed. The portable drug set described in 1.

  In the portable medicine set having the above-described configuration, the PTP sheet in which tablets are separately stored is housed in an outer bag made of a gas barrier material, and is packaged separately from a carrying protective case made of a paper mount. Therefore, the moisture contained in the paper board does not fill the outer bag of the gas barrier material. Therefore, the drug decomposition caused by the moisture contained in the paper board does not occur, thereby improving the drug stability during long-term storage. On the other hand, when using (during taking medicine), the PTP sheet can be taken out from the outer bag, and the PTP sheet can be attached to the carrying protective case so that the carrying package can be easily configured. In addition, it is possible to ensure improvement in medication compliance.

  Here, when a desiccant is used in the outer bag of the gas barrier material, moisture contained in the PTP sheet and moisture in the external atmosphere taken in when the PTP sheet is sealed in the outer bag are absorbed. The humidity in the bag is further reduced. Therefore, the drug stability during long-term storage is further improved.

  Further, if a plurality of PTP sheets and carrying protective cases are accommodated in the container and the packaging is made compact and common, efficiency in transportation and storage can be improved. Further, if the carrying protective case is composed of a plurality of folded paper mounts, the carrying case can be made lighter and more compact, so that the efficiency in transportation and storage can be further improved.

  ADVANTAGE OF THE INVENTION According to this invention, the novel packaging form which improved the drug stability at the time of long-term storage is ensured, ensuring the improvement of the carrying property and medication compliance of a PTP sheet.

It is a disassembled perspective view which shows one Embodiment of the chemical | medical agent set 10 for carrying. 3 is a perspective view schematically showing a PTP sheet 23. FIG. It is a perspective view which shows typically protective case 31 for carrying. 2 is a perspective view schematically showing a carrying package 51. FIG. It is a graph which shows stability with time of a drug.

  Embodiments of the present invention will be described below with reference to the drawings. The positional relationship such as up, down, left and right is based on the positional relationship shown in the drawings unless otherwise specified, and the dimensional ratios in the drawings are not limited to the illustrated ratios. The following embodiments are examples for explaining the present invention, and the present invention is not limited only to the embodiments.

(First embodiment)
FIG. 1 is an exploded perspective view showing a portable medicine set 10 of the present embodiment. The carrying medicine set 10 includes a PTP package 21, a carrying protective case 31, and a container 40 that is a paper individual packaging box that accommodates these. In the present embodiment, the PTP package 21 and the carrying protective case 31 are accommodated in the container 40 by three each. The three carrying protective cases 31 are enclosed in the transparent film 39.

  The PTP package 21 has a PTP sheet 23 accommodated in an outer bag 22 made of a gas barrier material. The gas barrier material constituting the outer bag 22 is made of a material having an aluminum vapor deposition layer or an aluminum foil and a resin layer, and prevents intrusion of gas and moisture (humidity) from the outside.

  FIG. 2 is a perspective view schematically showing the PTP sheet 23. The PTP sheet 23 accommodated in the PTP package 21 is formed of a substantially rectangular multilayer laminated sheet in plan view. The PTP sheet 23 has a configuration of a transparent base sheet 24 made of a thermoplastic resin, that is, polyvinyl chloride, and a breakable lid film 25 such as an aluminum foil attached to the back side thereof.

  The base material sheet 24 is provided with a plurality of pocket portions 24a bulging toward the surface side. In the present embodiment, the dome-shaped pocket portions 24a are formed in a 7 × 3 array. Each pocket 24a accommodates a round tablet M containing at least one steroid hormone as an active ingredient.

  The breakable lid film 25 is adhered to the back surface side of the base sheet 24 so as to cover the opening of each pocket portion 24a, whereby each pocket portion 24a is sealed.

  FIG. 3 is a perspective view schematically showing the carrying protective case 31. The carrying protective case 31 is a so-called wallet-type sheet case, and includes a four-fold paper mount 32.

  The paper mount 32 has a cover piece 33, a spine cover piece 34, a first holding piece 35, and a second holding piece 36 connected in this order. Each of the cover piece 33, spine piece 34, first holding piece 35, and second holding piece 36 has information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, and expiration date. It is printed (not shown).

  A plurality of holes 35a and 36a are formed in the first holding piece 35 and the second holding piece 36, respectively, and the shape and arrangement thereof correspond to the shape of the pocket portion 24a of the PTP sheet 23 and the arrangement of 7 × 3. It has become. An adhesive 37 for attaching the PTP sheet 23 is applied to the second sandwiching piece 36. In the present embodiment, a mounting portion for fixing the PTP sheet is configured from the plurality of holes 35 a and 36 a of the first and second holding pieces 35 and 36 and the adhesive 37.

  FIG. 4 is a perspective view schematically showing the carrying package 51. In the present embodiment, the carrying package 51 is configured by mounting the PTP sheet 23 on the paper mount 32. Hereinafter, a procedure for mounting the carrying package 51 will be described.

  First, the PTP sheet 23 is pressed and fixed to the adhesive 37 of the second holding piece 36 so that the dome-shaped pocket portion 24 a of the PTP sheet 23 is inserted into the plurality of holes 36 a of the second holding piece 36. Next, the second clamping piece 36 to which the PTP sheet 23 is fixed is bent so that the PTP sheet 23 is sandwiched between the first clamping piece 35 and the second clamping piece 36. Thereafter, the back cover piece 34 and the cover piece 33 are folded in order so as to wrap the PTP sheet 23. By these operations, a four-fold wallet-type carrying package 51 is obtained.

Hereinafter, the mechanism of action of the portable drug set 10 having the above configuration will be described with reference to FIG.
In general, the fluctuation range varies depending on the type of drug, but chemical changes over time due to light, heat, oxygen, humidity (water), etc. are unavoidable. That is, as shown by the line X in FIG. 5, when stored at room temperature in the atmosphere, the drug can undergo chemical changes such as decomposition even though it is slightly over time.

  Therefore, for the purpose of avoiding the entry of light, heat, oxygen, and humidity (water) from the outside, it is conventionally effective to enclose the drug in a gas barrier material bag and store it for a long time. According to this, as shown by the line Y in FIG. 5, exposure to light, heat, oxygen, and humidity (water) is suppressed, so that drug degradation is reduced compared to the line X during storage at room temperature in the atmosphere. Naturally it is expected to be suppressed.

  However, according to the knowledge of the present inventor, when the above-described carrying package 51 is sealed in the outer bag 22 of the gas barrier material and stored for a long time, surprisingly, as shown by the line Z in FIG. Furthermore, it has been newly found that the degradation of the drug in the carrying package 51 is enhanced.

  The reason is due to moisture contained in the paper mount 32 of the carrying package 51. That is, by enclosing the carrying package 51 in the outer bag 22 made of a gas barrier material, the entry of light, heat, oxygen, and humidity (water) from the outside is surely avoided. Water is not released to the outside. That is, when the carrying package 51 is composed of the paper mount 32, if the outer bag 22 made of a gas barrier material is adopted, the water contained in the paper mount 32 is not discharged to the outside but is filled in the outer bag 22. However, the result is that the drug decomposition proceeds according to the water content.

  On the other hand, in the portable medicine set 10 of the present embodiment, the PTP sheet 23 in which the round tablets M are separately stored is housed in the outer bag 22 made of a gas barrier material and is separate from the carrying protective case 31. It is packaged in. Therefore, there is no influence of moisture contained in the paper mount 32, and the drug stability during long-term storage is further enhanced.

  Moreover, in the portable medicine set 10 of the present embodiment, the PTP sheet 23 is taken out from the outer bag 22 during use (during taking medicine), and the PTP sheet 23 is attached to the carrying protective case 31 for carrying. The package 51 can be configured easily. Therefore, the portability and compliance of the PTP sheet 23 are not sacrificed.

Note that the present invention is not limited to the above-described embodiment, and appropriate modifications can be made without departing from the technical idea thereof.
For example, in the above embodiment, the PTP package 21 in which only the PTP sheet 23 is accommodated in the outer bag 22 of the gas barrier material is shown. However, for example, a desiccant may be accommodated together with the PTP sheet 23. By configuring the PTP package 21 in this manner, drug stability during long-term storage can be further enhanced.

  Moreover, in the said embodiment, although the PTP sheet | seat 23 in which the round tablet M containing at least one steroid hormone as an active ingredient was stored separately was shown, if it is a chemical | medical agent which can decompose | disassemble by the humidity in a bag, it is the same The effect of is produced. Furthermore, the kind of tablet is not particularly limited. Specific examples include naked tablets; coated tablets such as sugar-coated tablets and film-coated tablets; enteric tablets; sustained release tablets; sublingual tablets; chewable tablets; orally disintegrating tablets. Further, the shape of the tablet is not particularly limited. It is particularly useful in tablets that are relatively hygroscopic.

  Furthermore, in the said embodiment, although the polyvinyl chloride was shown as the base material sheet 24, according to desired performance, the thermoplastic resin well-known in this industry as the base material sheet 24, for example, a polyvinyl chloride-polyvinylidene chloride, is shown. A copolymer, polypropylene, polyethylene terephthalate, or the like can be used. Further, the number and arrangement of the pockets 24a of the PTP sheet 23 and the holes 35a and 36a of the first and second holding pieces 35 and 36 are appropriately determined in consideration of the usage / dose of the drug, design, handling, etc. Can be changed. For example, a 7 × 4 arrangement or a staggered arrangement may be used. Further, the number of installed pocket portions 24a of the PTP sheet 23 may be set to 2 to 31, for example, according to the usage and dosage. In this case, the number and arrangement of the holes 35a and 36a may be the same as the pocket portion 24a of the PTP sheet 23. Furthermore, the number of holes 35a and 36a may be set larger than the number of pockets 24a installed in the PTP sheet 23. In this case, the carrying protective case 31 may be a variety of PTPs having different numbers of pockets 24a. The sheet 23 can be used in common.

  INDUSTRIAL APPLICABILITY The present invention can be widely and effectively used in the field of pharmaceutical PTP sheet packaging.

DESCRIPTION OF SYMBOLS 10 Carrying agent set 21 PTP package 22 Outer bag 23 of gas barrier material PTP sheet 24 Base sheet 24a Pocket part 25 Cover film 31 Protective case 32 for carrying paper 35a Hole 36a Hole 37 Adhesive 40 Container 51 For carrying Package M Drug

Claims (4)

There is a PTP sheet in which medicines that can be decomposed due to humidity are separately stored, a carrying protective case on which the PTP sheet is attached to form a carrying package, and a container for housing the PTP sheet and the carrying protective case And
The carrying protective case consists of a paper mount on which information about the medicine is printed,
The PTP sheet is housed in an outer bag of a gas barrier material, and is packaged separately from the carrying protective case in the container,
A portable drug set in which the stability of the drug during long-term storage is further enhanced by the PTP sheet packaged separately from the protective case for carrying without being affected by moisture contained in the paper board. The PTP sheet is accommodated in the outer bag together with a desiccant,
The portable drug set according to claim 1. At least one of the PTP sheet and the carrying protective case is accommodated in the container,
The drug set for carrying according to claim 1 or 2. The carrying protective case is made of a plurality of folded paper mounts,
The paper mount has a mounting portion for fixing the PTP sheet.
The drug set for carrying according to any one of claims 1 to 3.

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