WO2022025103A1 - Medicine set - Google Patents

Medicine set Download PDF

Info

Publication number
WO2022025103A1
WO2022025103A1 PCT/JP2021/027865 JP2021027865W WO2022025103A1 WO 2022025103 A1 WO2022025103 A1 WO 2022025103A1 JP 2021027865 W JP2021027865 W JP 2021027865W WO 2022025103 A1 WO2022025103 A1 WO 2022025103A1
Authority
WO
WIPO (PCT)
Prior art keywords
ptp sheet
oxygen
drug
sheet
outer bag
Prior art date
Application number
PCT/JP2021/027865
Other languages
French (fr)
Japanese (ja)
Inventor
哲郎 吉成
亨 安澤
達雄 野村
正人 岩本
Original Assignee
ノーベルファーマ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ノーベルファーマ株式会社 filed Critical ノーベルファーマ株式会社
Priority to JP2022539522A priority Critical patent/JPWO2022025103A1/ja
Publication of WO2022025103A1 publication Critical patent/WO2022025103A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets

Definitions

  • the present invention relates to a drug set.
  • Ethinylestradiol is used as one of the active ingredients in drugs such as oral contraceptives and dysmenorrhea treatments. Since EE is decomposed over time under the influence of oxygen, the quality of a drug containing EE may deteriorate over time.
  • Patent Document 1 a method of blending an antioxidant in a tablet and a method of preventing autoxidation by using a compound in which EE is encapsulated with cyclodextrin have been proposed (Patent Document 1). ⁇ 3).
  • a method of stabilizing a drug containing EE by using a press-through pack package which is one of the packaging forms of a drug
  • PTP press-through pack package
  • PVC Polyvinyl chloride
  • PVC / PVDC polyvinylidene chloride
  • PVDC polyvinylidene chloride
  • the drug set of the present invention was devised in view of the above-mentioned problems, and an object thereof is to suppress oxygen decomposition of oxygen-deteriorating components contained in the drug and improve the stability of the drug. It is one of.
  • the drug set disclosed here includes a PTP sheet in which a drug containing a component deteriorated by oxygen is separately stored, an oxygen scavenger, and an outer bag of a gas barrier material containing the oxygen scavenger together with the PTP sheet. It is configured in preparation.
  • the disclosed drug set it is possible to suppress oxygen decomposition of components that are mixed with the drug and deteriorate due to oxygen, and improve the stability of the drug.
  • the PTP sheet will be described with reference to the posture along the horizontal plane.
  • the horizontal plane is shown in the front-back direction (in the figure, the front is indicated by “F” and the rear is indicated by “B") and in the left-right direction (in the figure, the left is indicated by “L” and the right is indicated by “R”. Shown).
  • the left-right direction the left and right are determined based on the state of facing from the front to the rear.
  • the direction of action of gravity is downward (indicated by "D” in the figure), and the opposite direction of the lower direction is upward (indicated by "U” in the figure).
  • FIG. 1 is an exploded perspective view showing the drug set 1 of the present embodiment.
  • the drug set 1 includes a carrying package 3 to which a PTP sheet is attached, an oxygen scavenger 4, and an outer bag 2 for accommodating the oxygen scavenger 4.
  • the internal space 20 of the outer bag 2 contains one carrying package 3 and one oxygen scavenger 4.
  • the positional relationship between the carrying package 3 and the oxygen scavenger 4 in the outer bag 2 is not particularly limited.
  • the outer bag 2 is provided with an opening 24 as an opening for communicating the internal space 20 with the outside. The opening 24 is not provided in the unopened outer bag 2 and is formed when the carrying package 3 is used.
  • FIG. 2 is a diagram schematically showing an unopened outer bag 2.
  • the outer bag 2 is made of a gas barrier material. Specifically, it is preferable to use a gas-barrier multilayer film, and the multilayer film is preferably made of an aluminum-deposited layer or a laminated film having an aluminum foil and a resin layer.
  • the multilayer film can prevent gas and moisture (humidity) from entering from the outside to the inside of the outer bag 2.
  • the outer bag 2 may be a substantially rectangular bag having a pair of long sides and a pair of short sides.
  • the periphery of the outer bag 2 may be surrounded by the seal portion 21.
  • the seal portion 21 is provided on the entire circumference of a substantially rectangular shape.
  • the planned opening portion 22 and the break line 23 are provided in the width direction of the short side of the outer bag 2.
  • the opening 24 is formed by removing the planned opening portion 22 that forms a part of the outer bag 2. Specifically, when the planned opening portion 22 is separated along the break line 23, the region of the planned opening portion 22 in the outer bag 2 is removed, and the opening 24 is opened. In this way, the carrying package 3 can be taken in and out through the opening 24.
  • a zip 25 may be provided in the vicinity of the break line 23 and the opening 24.
  • the zip 25 is a reopenable / closable occlusal tool including an engaging protrusion and an engaging recess.
  • the zip 25 may be of any kind such as a chuck, a slide fastener, and a zipper.
  • the material of the zip 25 is not particularly limited, and may be made of, for example, plastic.
  • the opening 24 is opened and closed according to the opening and closing of the zip 25. Since the outer bag 2 can be hermetically sealed, the carrying package 3 may be hermetically housed in the outer bag 2 again after use or during the drug holiday, whereby deterioration of the quality of the drug can be further prevented.
  • the carrying package 3 of FIG. 1 is composed of a PTP sheet 30 and a carrying protective case 33.
  • the configurations of the PTP sheet 30 will be described with reference to FIG. 3, and the configuration of the carrying protective case 33 with reference to FIG. 4 will be described.
  • FIG. 3 is a perspective view schematically showing the PTP sheet 30.
  • the PTP sheet 30 is made of a multilayer laminated sheet having a substantially rectangular shape in a plan view.
  • the PTP sheet 30 has a laminated structure having a base material sheet 31 on the upper surface and a lid film 32 on the lower surface.
  • the base sheet 31 is made of a material having oxygen permeability.
  • the material is preferably composed of a thermoplastic resin, specifically polyvinyl chloride (PVC).
  • PVC polyvinyl chloride
  • the oxygen contained in the pocket portion 31a in which the tablet M is separately stored is absorbed by the oxygen scavenger 4 included in the outer bag 2 (that is, in the pocket portion 31a). Oxygen contained in the pocket portion 31a is discharged to the outside).
  • Tablet M is a drug containing a component that is deteriorated by oxygen such as EE.
  • the base material sheet 31 is provided with a plurality of pocket portions 31a that are raised (bulged) upward.
  • the dome-shaped pocket portions 31a are formed in a 7x3 arrangement.
  • one round tablet M containing at least EE as an active ingredient is stored (divided storage) in each pocket portion 31a.
  • the lid film 32 is composed of a breakable material, for example, a single layer of aluminum foil.
  • the lid film 32 is attached to the lower surface side of the base sheet 31 so as to cover the opening of each pocket portion 31a, whereby each pocket portion 31a is sealed.
  • FIG. 4 is a perspective view schematically showing the carrying protective case 33.
  • the carrying protective case 33 is a so-called wallet type sheet case, and is made of a four-fold paper mount 34.
  • the paper mount 34 has a cover piece 35, a spine cover piece 36, a first holding piece 37, and a second holding piece 38 connected in this order.
  • Information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, expiration date, etc. is contained in the cover piece 35, the spine cover piece 36, the first holding piece 37, and the second holding piece 38, respectively. It may be printed (not shown).
  • a plurality of holes 37a and 38a are formed in the first holding piece 37 and the second holding piece 38, respectively, and the shape and arrangement thereof correspond to the shape of the pocket portion 31a of the PTP sheet 30 and the arrangement of 7x3. It has become.
  • the second holding piece 38 is coated with a slightly adhesive type adhesive 39 for attaching the PTP sheet 30.
  • a mounting portion for fixing the PTP sheet 30 is configured from the plurality of holes 37a, 38a of the first and second holding pieces 37, 38 and the adhesive 39.
  • FIG. 5 is a perspective view schematically showing the carrying package 3.
  • the carrying package 3 is configured by attaching the PTP sheet 30 to the paper mount 34.
  • the procedure for attaching the carrying package 3 will be described.
  • the PTP sheet 30 is pressed against the adhesive 39 of the second holding piece 38 and fixed so that the dome-shaped pocket portion 31a of the PTP sheet 30 is inserted into the plurality of holes 38a of the second holding piece 38.
  • the second holding piece 38 to which the PTP sheet 30 is fixed is bent so that the PTP sheet 30 is sandwiched between the first holding piece 37 and the second holding piece 38.
  • the spine cover piece 36 and the cover piece 35 are bent in order so as to wrap the PTP sheet 30.
  • the tablet M breaks through the lid film 32 of the PTP sheet 30 and passes through the hole 37a of the first holding piece 37 to the first. It is discharged below the holding piece 37 of.
  • the PTP sheet 30 is housed in the outer bag 2 in a state of being attached to the paper mount 34.
  • the user can easily refer to information about the drug when using the drug, for example, information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, expiration date, and the like.
  • information about the drug for example, information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, expiration date, and the like.
  • the oxygen scavenger 4 consists of a pouch filled with an oxygen absorbing substance.
  • the oxygen scavenger 4 has an oxygen scavenging function in the storage environment of the drug M.
  • oxygen in the outer bag 2 when unopened and residual oxygen in the pocket portion 31a when the lid film 32 is sealed are removed. Can be done. Further, it is also possible to remove oxygen that has entered from the outside over time after opening the outer bag 2. As a result, the decomposition of EE contained in the drug can be suppressed, and the quality of the drug M can be stabilized.
  • oxygen scavengers require a small amount of water for the reaction to absorb oxygen. If such an oxygen scavenger is used, the oxygen absorption function may not be exhibited at low humidity. Further, if an oxygen scavenger itself containing water is used, the water may be absorbed by the drug, resulting in drug decomposition or other quality deterioration. Therefore, it is preferable to use the oxygen scavenger 4 of the present embodiment having a moisture absorption (drying) function in addition to the oxygen absorption function. Thereby, the tablet M can be stored in a dry state.
  • the moisture contained in the paper mount 34 can also be absorbed.
  • the oxygen scavenger 4 having a moisture absorbing (drying) function in addition to the oxygen absorbing function, the drug can be stored in a dry state, and the quality of the drug can be stabilized.
  • the type of oxygen scavenger 4 is not limited as long as it exhibits an oxygen absorbing function in the storage environment of the drug. Further, as described above, the oxygen scavenger 4 may further have a hygroscopic (drying) function. Specific examples of commercially available products include oxygen scavengers manufactured by Pharmakeep (registered trademark; manufactured by Mitsubishi Gas Chemical Company, Inc.). The oxygen absorption capacity of the oxygen scavenger 4 may be appropriately selected depending on the capacity of the outer bag 2, the number of agents contained in the PTP sheet 30, and the size of the paper mount 34.
  • a PTP sheet prepared in the same manner as above using a sheet of PVC / PVDC material manufactured by Sumitomo Bakelite Co., Ltd., VSL-4610-N was also prepared.
  • Each created PTP sheet is put together with the number of paper mounts shown in Table 1 and oxygen scavenger (Mitsubishi Gas Chemical Co., Ltd., Pharmakeep (registered trademark) KD-20), and an aluminum bag (manufactured by Japan Co., Ltd.).
  • Detector Ultraviolet absorptiometer (measurement wavelength: 210 nm)
  • Table 1 shows the composition of each sample (drug set) and the residual rate of ethinyl estradiol (EE) after storage for 2 months (storage temperature: 50 ° C.).
  • EE ethinyl estradiol
  • Measurement sample (PTP sheet prepared using PVC material stored in an aluminum bag together with a paper mount and oxygen scavenger, Example 5) and reference example acquisition sample (PTP prepared using PVC / PVDC material) Place the sheet and Reference Example 2) in a thermostat at a temperature of 40 ° C ⁇ 2 ° C and a humidity of 75% RH ⁇ 5% RH, and quantify ethinyl estradiol at the start, storage for 1 month, storage for 3 months, and storage for 6 months. , The change in the content of ethinyl estradiol was investigated. The measurement was performed using 3 lots of each sample, and the quantification of ethinyl estradiol was performed using the following method.
  • Detector Fluorometer (excitation wavelength: 281 nm, detection wavelength: 305 nm) Column: Octadecylsilylated silica gel (5 ⁇ m), inner diameter 4.6 mm, length 15 cm Column temperature: Around 40 ° C Mobile phase: Acetonitrile / water mixture (11: 9) Flow rate: 1 mL / min Injection volume: 20 ⁇ L
  • FIG. 6 shows the change in the content of ethinyl estradiol (EE) when stored at 40 ° C.
  • Graphs PVC Nos. 1 to 3 show the results of Example 5, and graphs PVC / PVCC Nos. 1 to 3 show the results of Reference Example 2.
  • the sample measured sample, Example 5
  • the oxygen scavenger almost no decrease in ethinyl estradiol was confirmed over 6 months, and it was confirmed that the sample was extremely stable.
  • the cause of the difference in the suppression of decomposition of EE and the reduction of EE separately stored in PTP sheets made of different materials is, for example, the decomposition of EE by oxygen remaining in the pocket portion 31a of the base sheet 31 of the PTP sheet 30.
  • oxygen in the pocket portion 31a is effectively discharged to the outside of the pocket portion 31a by using a PVC material having a lower gas barrier property as compared with PVDC.
  • the base material sheet 31 is composed of a composite (PVC / PVDC) of polyvinyl chloride and polyvinylidene chloride. Since PVDC is excellent in moisture resistance and gas barrier property, by using a PTP sheet made of PVC / PVDC material, it is possible to prevent the moisture in the outer bag 2 and the moisture in the paper mount 34 from being absorbed by the chemicals. It is possible to prevent the oxygen in the outer bag 2 from entering the pocket portion 31a. However, as described above, when the base sheet 31 is prepared using the PVC / PVDC material, in consideration of the high gas barrier property of the PVDC, after storing the drug M and before sealing with the lid film 32.
  • a PTP sheet made of a gas barrier material containing a drug containing a component deteriorated by oxygen is provided, and an outer bag made of a gas barrier material containing the PTP sheet.
  • the PTP sheet may be configured to separately store the drug in a low oxygen state.
  • the drug set may use a PTP sheet made of a material having low oxygen permeability (or oxygen impermeable) such as PVC / PVDC material, and the air in the pocket may be replaced with an inert gas at the time of sealing. May realize a hypoxic state.
  • the PTP sheet of the drug set may have a moisture-proof function.
  • the PTP sheet when the PTP sheet is stored in a gas barrier outer bag and heat-sealed, it is preferable to remove oxygen by degassing or replacing the air in the outer bag with an inert gas. ..
  • a desiccant or oxygen scavenger when storing in the outer bag together with the paper mount, a desiccant or oxygen scavenger may be included.
  • the outer bag 2 has the zip 25, but the zip 25 may not be present. Further, in the present embodiment, one carrying package 3 included in the outer bag 2 is shown, but the number may be plural. Further, in the present embodiment, the oxygen scavenger 4 is separately enclosed in the outer bag 2 together with the carrying package 3, but may be attached to any position on the paper mount 34 of the carrying protective case 33. .. Alternatively, the oxygen scavenger 4 may be inserted between the first holding piece 37 and the second holding piece 38.
  • polyvinyl chloride (PVC) and a composite of polyvinyl chloride and polyvinylidene chloride (PVC / PVDC) are shown as the base sheet 31, but the base sheet can be used depending on the desired performance.
  • a thermoplastic resin known in the art for example, polypropylene, polyethylene terephthalate, or the like can be used.
  • the number and arrangement of the pocket portions 31a of the PTP sheet 30 and the holes 37a, 38a of the first and second holding pieces 37, 38 are appropriately determined in consideration of the usage / dose, designability, handleability, etc. of the drug. Can be changed. For example, it may be arranged in a 7x4 arrangement or in a staggered manner.
  • the number of pocket portions 31a of the PTP sheet 30 may be set to 2 to 31 according to the usage and dosage, for example. For example, if seven pocket portions 31a are arranged in a row for one week and the number is 7 ⁇ 4 rows or 7 ⁇ 3 rows, it is convenient for medication management and is preferable.
  • the number and arrangement of the holes 37a and 38a may be the same as those of the pocket portion 31a of the PTP sheet 30.
  • the number of holes 37a and 38a to be installed may be larger than the number of pockets 31a of the PTP sheet 30 to be installed. In this case, the carrying protective case 33 and various PTPs having different number of pockets 31a are installed.
  • the sheet 30 can be used in common.
  • the oxygen scavenger 4 is in the form of a bag, but is not limited to this, and may be in the form of a canister, a sheet, or a film. In the case of a sheet, it is easy to enclose it in the outer bag 2 together with the carrying package 3.

Abstract

The present invention improves the stability of a medicine by suppressing oxygen degradation of a component which is blended in the medicine and is deteriorated by oxygen. A medicine set 1 according to the present invention is configured to comprise a PTP sheet in which medicines that contain a component that is deteriorated by oxygen are separately contained, a deoxygenating agent 4, and an outer package 2 which contains the deoxygenating agent 4 together with the PTP sheet, said outer package 2 being formed of a gas barrier material.

Description

薬剤セットDrug set
　本発明は、薬剤セットに関する。 The present invention relates to a drug set.
　エチニルエストラジオール（ＥＥ；Ethinylestradiol）は、経口避妊薬や月経困難症治療剤のごとき薬剤における有効成分の一つとして用いられている。ＥＥは、酸素の影響を受けて経時的に分解されるため、ＥＥを含む薬剤では、経時的にその品質が低下するおそれがある。ＥＥの安定性を向上させる取り組みとして、錠剤中に抗酸化剤を配合させる方法や、ＥＥをシクロデキストリンで包接した化合物を用いることで自動酸化を防止する方法が提案されている（特許文献１～３）。 Ethinylestradiol (EE) is used as one of the active ingredients in drugs such as oral contraceptives and dysmenorrhea treatments. Since EE is decomposed over time under the influence of oxygen, the quality of a drug containing EE may deteriorate over time. As an effort to improve the stability of EE, a method of blending an antioxidant in a tablet and a method of preventing autoxidation by using a compound in which EE is encapsulated with cyclodextrin have been proposed (Patent Document 1). ~ 3).
国際公開第２０１２／１２０３６５号International Publication No. 2012/120365 特開２００９－１０２４２４号公報Japanese Unexamined Patent Publication No. 2009-102424 特表平１０－５０２３６２号公報Special Table No. 10-502362
　ここで、薬剤に添加剤を配合する方法の他に、医薬品の包装形態の一つであるプレススルーパック包装（ＰＴＰ；Press Through Package）により、ＥＥを含む薬剤の安定化を図る方法が考えられる。シート状のＰＴＰ（ＰＴＰシート）の容器側の素材として、ポリ塩化ビニル（ＰＶＣ；polyvinyl chloride）が広く用いられているが、ＰＶＣでは、空気中に存在する水分及び酸素の透過を完全に防止することはできない。 Here, in addition to the method of adding an additive to a drug, a method of stabilizing a drug containing EE by using a press-through pack package (PTP; Press Through Package), which is one of the packaging forms of a drug, can be considered. .. Polyvinyl chloride (PVC) is widely used as a material on the container side of a sheet-shaped PTP (PTP sheet), but PVC completely prevents the permeation of moisture and oxygen existing in the air. It is not possible.
　そこで、より防湿性及びガスバリア性に優れた、ＰＶＣとポリ塩化ビニリデン（ＰＶＤＣ；polyvinylidene chloride）との複合体（ＰＶＣ／ＰＶＤＣ）をＰＴＰシートの素材として用いることがＥＥを含む薬剤の安定化に有用と考えられている。しかしながら、ＰＶＣ／ＰＶＤＣを素材としたＰＴＰシートを用いても、ＥＥの分解を完全に防止することはできないため、ＥＥの安定性の向上を図るための、さらなる工夫が必要である。なお、ＥＥの他、酸素により劣化する成分を含む他の薬剤についても同様の課題がある。 Therefore, it is useful to use a complex (PVC / PVDC) of PVC and polyvinylidene chloride (PVDC), which has better moisture resistance and gas barrier properties, as a material for PTP sheets to stabilize drugs including EE. It is believed that. However, even if a PTP sheet made of PVC / PVDC is used, the decomposition of EE cannot be completely prevented, so further measures are required to improve the stability of EE. In addition to EE, there are similar problems with other drugs containing components that are deteriorated by oxygen.
　本発明の薬剤セットは、前述したような課題に鑑み創案されたものであり、薬剤に配合された、酸素により劣化する成分についての酸素分解を抑制し、薬剤の安定性を向上させることを目的の一つとする。 The drug set of the present invention was devised in view of the above-mentioned problems, and an object thereof is to suppress oxygen decomposition of oxygen-deteriorating components contained in the drug and improve the stability of the drug. It is one of.
　ここで開示する薬剤セットは、酸素により劣化する成分を含む薬剤が区分収納されたＰＴＰシートと、脱酸素剤と、前記脱酸素剤を前記ＰＴＰシートとともに収容するガスバリア性素材の外袋と、を備えて構成されている。 The drug set disclosed here includes a PTP sheet in which a drug containing a component deteriorated by oxygen is separately stored, an oxygen scavenger, and an outer bag of a gas barrier material containing the oxygen scavenger together with the PTP sheet. It is configured in preparation.
　開示の薬剤セットによれば、薬剤に配合された、酸素により劣化する成分についての酸素分解を抑制し、薬剤の安定性を向上させることができる。 According to the disclosed drug set, it is possible to suppress oxygen decomposition of components that are mixed with the drug and deteriorate due to oxygen, and improve the stability of the drug.
薬剤セットの一実施形態を示す分解斜視図である。It is an exploded perspective view which shows one Embodiment of a drug set. 外袋を模式的に示す図である。It is a figure which shows typically the outer bag. ＰＴＰシートを模式的に示す斜視図である。It is a perspective view which shows the PTP sheet schematically. 携行用保護ケースを模式的に示す図である。It is a figure which shows typically the protective case for carrying. 携行用パッケージを模式的に示す図である。It is a figure which shows typically the carrying package. ＥＥの含量変化を示す図である。It is a figure which shows the content change of EE.
　以下、図面を参照して本発明の実施の形態を説明する。ただし、以下に説明する実施形態は、あくまでも例示であり、以下に明示しない種々の変形又は技術の適用を排除する意図はない。例えば、本実施形態を、その趣旨を逸脱しない範囲で種々変形して実施することができる。なお、以下の説明で用いる図面において、同一符号を付した部分は、特に断らない限り、同一若しくは同様の部分を表す。 Hereinafter, embodiments of the present invention will be described with reference to the drawings. However, the embodiments described below are merely examples, and there is no intention of excluding the application of various modifications or techniques not specified below. For example, the present embodiment can be variously modified and implemented without departing from the spirit of the present embodiment. In the drawings used in the following description, the parts with the same reference numerals represent the same or similar parts unless otherwise specified.
　本実施形態では、ＰＴＰシートが水平面に沿う姿勢のものを基準にして説明する。水平面は、前後方向（図中には前方を「Ｆ」で示すとともに後方を「Ｂ」で示す）および左右方向（図中には左方を「Ｌ」で示すとともに右方を「Ｒ」で示す）を有する面とする。左右方向については、前方から後方へ向いた状態を基準に左右を定める。また、鉛直方向のうち重力の作用方向を下方（図中には「Ｄ」で示す）とし、下方の反対方向を上方（図中には「Ｕ」で示す）とする。 In this embodiment, the PTP sheet will be described with reference to the posture along the horizontal plane. The horizontal plane is shown in the front-back direction (in the figure, the front is indicated by "F" and the rear is indicated by "B") and in the left-right direction (in the figure, the left is indicated by "L" and the right is indicated by "R". Shown). Regarding the left-right direction, the left and right are determined based on the state of facing from the front to the rear. In the vertical direction, the direction of action of gravity is downward (indicated by "D" in the figure), and the opposite direction of the lower direction is upward (indicated by "U" in the figure).
［Ｉ．一実施形態］
　以下、本実施形態における本発明の構成を項目［１］で述べ、本発明による作用機序を項目［２］で述べる。そして、変形例を項目［３］で述べ、その他を項目［４］で述べる。 [I. Embodiment]
Hereinafter, the configuration of the present invention in the present embodiment will be described in item [1], and the mechanism of action according to the present invention will be described in item [2]. Then, a modification example will be described in the item [3], and the others will be described in the item [4].
［１．構成］
　図１は、本実施形態の薬剤セット１を示す分解斜視図である。薬剤セット１は、ＰＴＰシートが装着された携行用パッケージ３と、脱酸素剤４と、これらを収容する外袋２とを備えている。本実施形態では、外袋２の内部空間２０には、携行用パッケージ３が１つ、脱酸素剤４が１つ収容されている。外袋２内における携行用パッケージ３及び脱酸素剤４の位置関係は特に限定されない。外袋２には、内部空間２０を外部と連通させる開口として開口部２４が設けられている。開口部２４は、未開封の外袋２には設けられておらず、携行用パッケージ３の使用時に形成される。 [1. composition]
FIG. 1 is an exploded perspective view showing the drug set 1 of the present embodiment. The drug set 1 includes a carrying package 3 to which a PTP sheet is attached, an oxygen scavenger 4, and an outer bag 2 for accommodating the oxygen scavenger 4. In the present embodiment, the internal space 20 of the outer bag 2 contains one carrying package 3 and one oxygen scavenger 4. The positional relationship between the carrying package 3 and the oxygen scavenger 4 in the outer bag 2 is not particularly limited. The outer bag 2 is provided with an opening 24 as an opening for communicating the internal space 20 with the outside. The opening 24 is not provided in the unopened outer bag 2 and is formed when the carrying package 3 is used.
　図２は、未開封の外袋２を模式的に示す図である。外袋２は、ガスバリア性素材から構成される。具体的には、ガスバリア性多層フィルムを用いることが好ましく、当該多層フィルムは、アルミ蒸着層又はアルミ箔と樹脂層とを有する積層フィルムからなることが好ましい。当該多層フィルムにより外袋２の外部から内部に気体及び水分（湿度）が侵入するのを防止することができる。 FIG. 2 is a diagram schematically showing an unopened outer bag 2. The outer bag 2 is made of a gas barrier material. Specifically, it is preferable to use a gas-barrier multilayer film, and the multilayer film is preferably made of an aluminum-deposited layer or a laminated film having an aluminum foil and a resin layer. The multilayer film can prevent gas and moisture (humidity) from entering from the outside to the inside of the outer bag 2.
　外袋２は、一対の長辺と一対の短辺とを有する略長方形の袋状のものであってよい。外袋２の周囲は、シール部２１によって囲繞されていてもよい。本実施形態では、シール部２１が略長方形の全周に設けられている。 The outer bag 2 may be a substantially rectangular bag having a pair of long sides and a pair of short sides. The periphery of the outer bag 2 may be surrounded by the seal portion 21. In the present embodiment, the seal portion 21 is provided on the entire circumference of a substantially rectangular shape.
　本実施形態では、外袋２の短辺の幅方向には、開口予定部２２及び破断線２３が設けられている。図１に示すように、開口部２４は、外袋２の一部をなす開口予定部２２が取り除かれることで形成される。具体的には、開口予定部２２が破断線２３に沿って切り離されると、外袋２における開口予定部２２の領域が取り除かれ、開口部２４が開放される。このように、開口部２４を介して携行用パッケージ３を出し入れすることができる。 In the present embodiment, the planned opening portion 22 and the break line 23 are provided in the width direction of the short side of the outer bag 2. As shown in FIG. 1, the opening 24 is formed by removing the planned opening portion 22 that forms a part of the outer bag 2. Specifically, when the planned opening portion 22 is separated along the break line 23, the region of the planned opening portion 22 in the outer bag 2 is removed, and the opening 24 is opened. In this way, the carrying package 3 can be taken in and out through the opening 24.
　破断線２３及び開口部２４の付近には、ジップ２５が設けられていてもよい。ジップ２５は、係合突起及び係合凹部からなる再開閉可能な咬合具である。ジップ２５は、チャック、スライドファスナー、ジッパー等のいずれの種類のものであってもよい。ジップ２５の材質は特に限定されず、例えばプラスチック製であってもよい。開口部２４は、ジップ２５の開閉に応じて開閉される。外袋２は密閉可能であるため、使用後や休薬期間に携行用パッケージ３を再び外袋２に密閉収容してもよく、これにより、薬剤の品質の低下をさらに防止することができる。 A zip 25 may be provided in the vicinity of the break line 23 and the opening 24. The zip 25 is a reopenable / closable occlusal tool including an engaging protrusion and an engaging recess. The zip 25 may be of any kind such as a chuck, a slide fastener, and a zipper. The material of the zip 25 is not particularly limited, and may be made of, for example, plastic. The opening 24 is opened and closed according to the opening and closing of the zip 25. Since the outer bag 2 can be hermetically sealed, the carrying package 3 may be hermetically housed in the outer bag 2 again after use or during the drug holiday, whereby deterioration of the quality of the drug can be further prevented.
　本実施形態では、図１の携行用パッケージ３は、ＰＴＰシート３０と、携行用保護ケース３３とで構成されている。以下、ＰＴＰシート３０について図３を参照し、携行用保護ケース３３について図４を参照して、それぞれの構成を説明する。 In the present embodiment, the carrying package 3 of FIG. 1 is composed of a PTP sheet 30 and a carrying protective case 33. Hereinafter, the configurations of the PTP sheet 30 will be described with reference to FIG. 3, and the configuration of the carrying protective case 33 with reference to FIG. 4 will be described.
　図３は、ＰＴＰシート３０を模式的に示す斜視図である。ＰＴＰシート３０は、平面視において略長方形状の多層積層シートからなる。ＰＴＰシート３０は、上面に基材シート３１を有し、下面に蓋フィルム３２を有する積層構成になっている。 FIG. 3 is a perspective view schematically showing the PTP sheet 30. The PTP sheet 30 is made of a multilayer laminated sheet having a substantially rectangular shape in a plan view. The PTP sheet 30 has a laminated structure having a base material sheet 31 on the upper surface and a lid film 32 on the lower surface.
　好ましい態様において、基材シート３１は、酸素透過性を有する素材により構成される。当該素材は、熱可塑性樹脂、詳細にはポリ塩化ビニル（ＰＶＣ）で構成されることが好ましい。これにより、蓋フィルム３２の密閉時におけるポケット部３１ａ内の残存酸素をポケット部３１ａの外に排出させることができる。基材シート３１の酸素透過性は、外袋２に同梱される脱酸素剤４によって、錠剤Ｍが区分収納されたポケット部３１ａ内に含まれる酸素が吸収される（つまり、ポケット部３１ａ内に含まれる酸素がポケット部３１ａから外部に排出される）程度であることが好ましい。錠剤Ｍは、ＥＥのごとき酸素により劣化する成分を含む薬剤である。 In a preferred embodiment, the base sheet 31 is made of a material having oxygen permeability. The material is preferably composed of a thermoplastic resin, specifically polyvinyl chloride (PVC). As a result, the residual oxygen in the pocket portion 31a when the lid film 32 is sealed can be discharged to the outside of the pocket portion 31a. Regarding the oxygen permeability of the base sheet 31, the oxygen contained in the pocket portion 31a in which the tablet M is separately stored is absorbed by the oxygen scavenger 4 included in the outer bag 2 (that is, in the pocket portion 31a). Oxygen contained in the pocket portion 31a is discharged to the outside). Tablet M is a drug containing a component that is deteriorated by oxygen such as EE.
　基材シート３１には、上方に隆起（膨出）したポケット部３１ａが複数設けられている。本実施形態では、ドーム状のポケット部３１ａが７ｘ３の配列で形成されている。各ポケット部３１ａには、前述のごとく、有効成分として少なくともＥＥを含有する丸形錠剤Ｍがそれぞれ１つずつ収納（区分収納）されている。 The base material sheet 31 is provided with a plurality of pocket portions 31a that are raised (bulged) upward. In this embodiment, the dome-shaped pocket portions 31a are formed in a 7x3 arrangement. As described above, one round tablet M containing at least EE as an active ingredient is stored (divided storage) in each pocket portion 31a.
　蓋フィルム３２は、可破断性の素材、例えば、アルミ箔の単層で構成される。蓋フィルム３２は、各ポケット部３１ａの開口を覆うように基材シート３１の下面側に貼着されており、これにより、各ポケット部３１ａが密封されている。 The lid film 32 is composed of a breakable material, for example, a single layer of aluminum foil. The lid film 32 is attached to the lower surface side of the base sheet 31 so as to cover the opening of each pocket portion 31a, whereby each pocket portion 31a is sealed.
　図４は、携行用保護ケース３３を模式的に示す斜視図である。本実施形態において、携行用保護ケース３３は、所謂ウォレット型のシートケースであり、４つ折りの紙製台紙３４からなる。 FIG. 4 is a perspective view schematically showing the carrying protective case 33. In the present embodiment, the carrying protective case 33 is a so-called wallet type sheet case, and is made of a four-fold paper mount 34.
　紙製台紙３４は、表紙片３５、背表紙片３６、第１の挟持片３７、第２の挟持片３８がこの順に連接されたものである。これら表紙片３５、背表紙片３６、第１の挟持片３７、第２の挟持片３８には、薬剤の名称、用法・用量、効能・効果、使用上の注意、使用期限などの情報がそれぞれ印刷されていてもよい（図示省略）。 The paper mount 34 has a cover piece 35, a spine cover piece 36, a first holding piece 37, and a second holding piece 38 connected in this order. Information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, expiration date, etc. is contained in the cover piece 35, the spine cover piece 36, the first holding piece 37, and the second holding piece 38, respectively. It may be printed (not shown).
　第１の挟持片３７及び第２の挟持片３８には、複数の孔３７ａ，３８ａがそれぞれ形成されており、その形状および配列は、ＰＴＰシート３０のポケット部３１ａの形状および７ｘ３の配列に対応したものとなっている。第２の挟持片３８には、ＰＴＰシート３０を貼着するための微粘着タイプの粘着剤３９が塗布されている。本実施形態では、第１及び第２の挟持片３７，３８の複数の孔３７ａ，３８ａ及び粘着剤３９とからＰＴＰシート３０を固定する装着部が構成されている。 A plurality of holes 37a and 38a are formed in the first holding piece 37 and the second holding piece 38, respectively, and the shape and arrangement thereof correspond to the shape of the pocket portion 31a of the PTP sheet 30 and the arrangement of 7x3. It has become. The second holding piece 38 is coated with a slightly adhesive type adhesive 39 for attaching the PTP sheet 30. In the present embodiment, a mounting portion for fixing the PTP sheet 30 is configured from the plurality of holes 37a, 38a of the first and second holding pieces 37, 38 and the adhesive 39.
　図５は、携行用パッケージ３を模式的に示す斜視図である。本実施形態において、携行用パッケージ３は、紙製台紙３４にＰＴＰシート３０を装着することにより構成される。以下、携行用パッケージ３の装着手順について説明する。 FIG. 5 is a perspective view schematically showing the carrying package 3. In the present embodiment, the carrying package 3 is configured by attaching the PTP sheet 30 to the paper mount 34. Hereinafter, the procedure for attaching the carrying package 3 will be described.
　まず、ＰＴＰシート３０のドーム状のポケット部３１ａが第２の挟持片３８の複数の孔３８ａに挿通するように、ＰＴＰシート３０を第２の挟持片３８の粘着剤３９へ押し付けて固定する。次に、第１の挟持片３７及び第２の挟持片３８の間でＰＴＰシート３０を挟み込むように、ＰＴＰシート３０が固定された第２の挟持片３８を折り曲げる。その後、ＰＴＰシート３０を包むように背表紙片３６及び表紙片３５を順に折り曲げる。これらの操作により、４つ折りウォレット型の携行用パッケージ３が得られる。 First, the PTP sheet 30 is pressed against the adhesive 39 of the second holding piece 38 and fixed so that the dome-shaped pocket portion 31a of the PTP sheet 30 is inserted into the plurality of holes 38a of the second holding piece 38. Next, the second holding piece 38 to which the PTP sheet 30 is fixed is bent so that the PTP sheet 30 is sandwiched between the first holding piece 37 and the second holding piece 38. After that, the spine cover piece 36 and the cover piece 35 are bent in order so as to wrap the PTP sheet 30. By these operations, a four-fold wallet type carrying package 3 is obtained.
　第２の挟持片３８に固定されたポケット部３１ａを上方から指で押すと、錠剤Ｍは、ＰＴＰシート３０の蓋フィルム３２を突き破り、第１の挟持片３７の孔３７ａを通って、第１の挟持片３７の下方に排出される。 When the pocket portion 31a fixed to the second holding piece 38 is pushed from above with a finger, the tablet M breaks through the lid film 32 of the PTP sheet 30 and passes through the hole 37a of the first holding piece 37 to the first. It is discharged below the holding piece 37 of.
　本実施形態では、ＰＴＰシート３０が紙製台紙３４に装着された状態で外袋２に収容される。これにより、ユーザーは薬剤の使用時に薬剤に関する情報、例えば、薬剤の名称、用法・用量、効能・効果、使用上の注意、使用期限などの情報を容易に参照することができる。また、使用前に紙製台紙３４にＰＴＰシート３０を装着する手間を省けるため、調剤薬局での販売を容易にすることができる。 In the present embodiment, the PTP sheet 30 is housed in the outer bag 2 in a state of being attached to the paper mount 34. As a result, the user can easily refer to information about the drug when using the drug, for example, information such as the name of the drug, usage / dose, efficacy / effect, precautions for use, expiration date, and the like. In addition, since it is possible to save the trouble of attaching the PTP sheet 30 to the paper mount 34 before use, it is possible to facilitate sales at dispensing pharmacies.
　図１に戻り、脱酸素剤４は、酸素吸収物質を充填した小袋からなる。脱酸素剤４は、薬剤Ｍの保存環境において脱酸素機能を有する。ＰＴＰシート３０とともに脱酸素剤４を外袋２に同梱することで、未開封時の外袋２内の酸素と、蓋フィルム３２の密閉時におけるポケット部３１ａ内の残存酸素とを除去することができる。さらに、外袋２の開封後に経時で外部から浸入してくる酸素を除去することもできる。これにより、薬剤に含まれるＥＥの分解を抑制することができ、ひいては、薬剤Ｍの品質の安定化を図ることができる。 Returning to FIG. 1, the oxygen scavenger 4 consists of a pouch filled with an oxygen absorbing substance. The oxygen scavenger 4 has an oxygen scavenging function in the storage environment of the drug M. By including the oxygen scavenger 4 together with the PTP sheet 30 in the outer bag 2, oxygen in the outer bag 2 when unopened and residual oxygen in the pocket portion 31a when the lid film 32 is sealed are removed. Can be done. Further, it is also possible to remove oxygen that has entered from the outside over time after opening the outer bag 2. As a result, the decomposition of EE contained in the drug can be suppressed, and the quality of the drug M can be stabilized.
　ここで、脱酸素剤の中には、酸素を吸収する反応に微量の水分を必要とするものがある。このような脱酸素剤を用いると、低湿度においては酸素吸収機能が発揮されないおそれがある。また、脱酸素剤自体に水分を含有させたものを用いると、その水分が薬剤に吸収されることで薬剤分解やその他の品質劣化が起こるおそれがある。そこで、本実施形態の脱酸素剤４は、酸素吸収機能に加え、吸湿（乾燥）機能を有するものを用いることが好ましい。これにより、錠剤Ｍを乾燥状態で保存することができる。さらに、本実施形態では、ＰＴＰシート３０は紙製台紙３４に装着された状態で外袋２に同梱されるため、紙製台紙３４に含まれる湿気も吸湿することができる。また、外袋２の開封後に経時で外部から浸入してくる湿気を吸湿することもできる。このように、酸素吸収機能に加え、吸湿（乾燥）機能を有する脱酸素剤４を用いることで、薬剤を乾燥状態で保存することができ、薬剤の品質の安定化を図ることができる。 Here, some oxygen scavengers require a small amount of water for the reaction to absorb oxygen. If such an oxygen scavenger is used, the oxygen absorption function may not be exhibited at low humidity. Further, if an oxygen scavenger itself containing water is used, the water may be absorbed by the drug, resulting in drug decomposition or other quality deterioration. Therefore, it is preferable to use the oxygen scavenger 4 of the present embodiment having a moisture absorption (drying) function in addition to the oxygen absorption function. Thereby, the tablet M can be stored in a dry state. Further, in the present embodiment, since the PTP sheet 30 is bundled with the outer bag 2 in a state of being attached to the paper mount 34, the moisture contained in the paper mount 34 can also be absorbed. In addition, it is also possible to absorb moisture that infiltrates from the outside over time after opening the outer bag 2. As described above, by using the oxygen scavenger 4 having a moisture absorbing (drying) function in addition to the oxygen absorbing function, the drug can be stored in a dry state, and the quality of the drug can be stabilized.
　脱酸素剤４は、薬剤の保存環境において酸素吸収機能を発揮するものである限り、その種類は限定されない。また上述した通り、脱酸素剤４は、吸湿（乾燥）機能をさらに備えたものであっても良い。具体的な市販品としては、例えば、ファーマキープ（登録商標；三菱ガス化学株式会社製）の脱酸素剤が挙げられる。脱酸素剤４の酸素吸収能力は、外袋２の容量及びＰＴＰシート３０に収容される薬剤の個数や紙製台紙３４の大きさに応じて適宜選択されてよい。 The type of oxygen scavenger 4 is not limited as long as it exhibits an oxygen absorbing function in the storage environment of the drug. Further, as described above, the oxygen scavenger 4 may further have a hygroscopic (drying) function. Specific examples of commercially available products include oxygen scavengers manufactured by Pharmakeep (registered trademark; manufactured by Mitsubishi Gas Chemical Company, Inc.). The oxygen absorption capacity of the oxygen scavenger 4 may be appropriately selected depending on the capacity of the outer bag 2, the number of agents contained in the PTP sheet 30, and the size of the paper mount 34.
［２．作用機序］
　以下、上記構成の薬剤セット１の作用機序について、薬剤の成分としてのＥＥの安定性の向上の検証結果を参照して説明する。 [2. Mechanism of action]
Hereinafter, the mechanism of action of the drug set 1 having the above constitution will be described with reference to the verification results of the improvement of the stability of EE as a component of the drug.
［２－１．ＰＴＰシートに用いる基材シートの素材の比較］
［２－１－１．試料の調製］
　まず、試料の調製について説明する。
（１）ジェミーナ（登録商標）配合錠（１錠中にエチニルエストラジオール０．０２ｍｇ及びレボノルゲストレル０．０９ｍｇ配合、ノーベルファーマ株式会社製）２８錠を、錠剤を格納するポケット（７錠×４列）が形成されたＰＶＣ素材（住友ベークライト株式会社製、VSS-F110-UV-3）のシートに区分収納し、ＰＴＰ用アルミニウム箔（昭北ラミネート工業株式会社製）を用いてシールしてＰＴＰシートを作成した。
（２）別に、ＰＶＣ／ＰＶＤＣ素材（住友ベークライト株式会社製、VSL-4610-N）のシートを用いて上記と同様に作成したＰＴＰシートも準備した。
　作成した各ＰＴＰシートを、表１記載の数の紙製台紙と脱酸素剤（三菱ガス化学株式会社製、ファーマキープ（登録商標）KD-20）とともに、アルミ袋（株式会社生産日本社製、ラミジップスタンドタイプAL-11）に入れ、ヒートシールにより封をした薬剤セットを複数種類作成した。作成した薬剤セットをあらかじめ室温にて一週間放置し、測定試料とした。
（３）また、脱酸素剤による安定化効果を確認するための参考例として、ジェミーナ（登録商標）配合錠８４錠を、ＰＴＰシートに収納せずにバラの状態で紙製台紙３枚及び脱酸素剤３個と共に上記と同じアルミ袋に入れ、ヒートシールにより封をした試料も作成した。 [2-1. Comparison of base sheet materials used for PTP sheets]
[2-1-1. Sample preparation]
First, the preparation of the sample will be described.
(1) 28 tablets of Gemina (registered trademark) combination tablets (containing 0.02 mg of ethinyl estradiol and 0.09 mg of levonorgestrel in one tablet, manufactured by Nobelpharma Co., Ltd.), and pockets for storing tablets (7 tablets x 4 rows) The PTP sheet is separated and stored in a sheet of PVC material (manufactured by Sumitomo Bakelite Co., Ltd., VSS-F110-UV-3) on which is formed, and sealed with aluminum foil for PTP (manufactured by Shohoku Laminate Industry Co., Ltd.). Created.
(2) Separately, a PTP sheet prepared in the same manner as above using a sheet of PVC / PVDC material (manufactured by Sumitomo Bakelite Co., Ltd., VSL-4610-N) was also prepared.
Each created PTP sheet is put together with the number of paper mounts shown in Table 1 and oxygen scavenger (Mitsubishi Gas Chemical Co., Ltd., Pharmakeep (registered trademark) KD-20), and an aluminum bag (manufactured by Japan Co., Ltd.). We created multiple types of drug sets that were placed in the Lamizip stand type AL-11) and sealed with a heat seal. The prepared drug set was left at room temperature for one week in advance to prepare a measurement sample.
(3) In addition, as a reference example for confirming the stabilizing effect of the oxygen scavenger, 84 Gemina (registered trademark) combination tablets are not stored in the PTP sheet, but are separated into 3 paper mounts and removed. A sample was also prepared by putting it in the same aluminum bag as above together with three oxygen scavengers and sealing it with a heat seal.
［２－１－２．実験方法］
　次に、実験方法を説明する。
　作成したそれぞれの試料を、５０℃に設定された恒温器に入れ、開始時と２カ月保存後のそれぞれにおいて、下記の方法によりエチニルエストラジオールの定量を行ってエチニルエストラジオールの含量変化（開始時の含量を100とした場合における残存率（％））を調べた。 [2-1-2. experimental method]
Next, the experimental method will be described.
Each of the prepared samples was placed in an incubator set at 50 ° C., and ethinyl estradiol was quantified by the following method at the start and after storage for 2 months, respectively, to change the content of ethinyl estradiol (content at the start). The residual rate (%) when was set to 100 was investigated.
　エチニルエストラジオールの定量方法を以下に説明する。
（１）錠剤１個に対し、アセトニトリル／水混液（１１：９）１０ｍLで振とう抽出し、孔径０．４５μｍのメンブランフィルターでろ過した液を、試料溶液とした。調製した試料溶液につき、下記の条件によるHPLC分析を行い、エチニルエストラジオールのピーク面積を求め、エチニルエストラジオール標準物質による分析結果との比較に基づき、エチニルエストラジオールの含量を求めた。
（２）以下は、定量の条件である。
　検出器：紫外吸光光度計（測定波長：２１０nm）
　カラム：オクタデシルシリル化シリカゲル（５μm）、内径４．６mm、長さ１５cm
　カラム温度：４０℃付近
　移動相：アセトニトリル／水混液（１１：９）
　流量：１．２ｍL/分
　注入量：５０μL The method for quantifying ethinyl estradiol will be described below.
(1) One tablet was extracted by shaking with 10 mL of an acetonitrile / water mixed solution (11: 9), and the solution filtered through a membrane filter having a pore size of 0.45 μm was used as a sample solution. The prepared sample solution was subjected to HPLC analysis under the following conditions to determine the peak area of ethinyl estradiol, and the content of ethinyl estradiol was determined based on the comparison with the analysis results using the ethinyl estradiol standard substance.
(2) The following are quantitative conditions.
Detector: Ultraviolet absorptiometer (measurement wavelength: 210 nm)
Column: Octadecylsilylated silica gel (5 μm), inner diameter 4.6 mm, length 15 cm
Column temperature: Around 40 ° C Mobile phase: Acetonitrile / water mixture (11: 9)
Flow rate: 1.2 mL / min Injection amount: 50 μL
［２－１－３．結果］
　検証結果を表１に示す。表１は、各試料（薬剤セット）の構成と２カ月保存後におけるエチニルエストラジオール（ＥＥ）の残存率（保存温度：５０℃）を示す。ＰＶＣ／ＰＶＤＣを用いて作成されたＰＴＰシートを、脱酸素剤を含まずにアルミ袋に入れた試料（比較例１）では、保存２カ月後において、約９％のエチニルエストラジオールの減少が確認された。ＰＶＣ／ＰＶＤＣを用いて作成されたＰＴＰシートを脱酸素剤と共にアルミ袋に入れた試料（実施例１、実施例２）では、エチニルエストラジオールの減少は約６％まで抑えられており、ＰＴＰシートと共に脱酸素剤を封入することによって、エチニルエストラジオールの分解抑制効果が得られることが確認された。バラの錠剤を脱酸素剤と共に封入した試料における結果（参考例１）から、脱酸素剤の効果により錠剤そのもののエチニルエストラジオールの分解が効果的に抑制されることが確認されているが、実施例１及び２の結果から、ＰＶＣ／ＰＶＤＣ製のＰＴＰシートに区分収納された態様であっても、エチニルエストラジオールの分解抑制効果が得られることを示すことが確認された。
　ＰＶＣを用いて作成されたＰＴＰシートを脱酸素剤と共にアルミ袋に入れた試料（実施例３、実施例４）では、エチニルエストラジオールの減少量が約２%以下に抑えられていた。この結果から、酸素透過性を有するＰＶＣを用いて作成されたＰＴＰシートを脱酸素剤とともにガスバリア性を有する袋に封入することにより、エチニルエストラジオールの分解が、特に効果的に抑制されることが確認された。 [2-1-3. result]
The verification results are shown in Table 1. Table 1 shows the composition of each sample (drug set) and the residual rate of ethinyl estradiol (EE) after storage for 2 months (storage temperature: 50 ° C.). In a sample (Comparative Example 1) in which a PTP sheet prepared using PVC / PVDC was placed in an aluminum bag without containing an oxygen scavenger, a decrease of about 9% in ethinyl estradiol was confirmed after 2 months of storage. rice field. In the samples (Examples 1 and 2) in which a PTP sheet prepared using PVC / PVDC was placed in an aluminum bag together with an oxygen scavenger, the decrease in ethinyl estradiol was suppressed to about 6%, together with the PTP sheet. It was confirmed that the effect of suppressing the decomposition of ethinyl estradiol can be obtained by encapsulating an oxygen scavenger. From the results (Reference Example 1) of a sample in which a rose tablet was encapsulated with an oxygen scavenger, it was confirmed that the effect of the oxygen scavenger effectively suppressed the decomposition of ethinyl estradiol in the tablet itself. From the results of 1 and 2, it was confirmed that the effect of suppressing the decomposition of ethinyl estradiol can be obtained even in the mode in which the PTP sheet made of PVC / PVDC is separately stored.
In the samples (Examples 3 and 4) in which the PTP sheet prepared using PVC was placed in an aluminum bag together with an oxygen scavenger, the amount of decrease in ethinyl estradiol was suppressed to about 2% or less. From this result, it was confirmed that the decomposition of ethinyl estradiol was particularly effectively suppressed by enclosing the PTP sheet prepared using PVC having oxygen permeability in a bag having gas barrier property together with an oxygen scavenger. Was done.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
［２－２．ＰＶＣ素材の基材シートを用いた薬剤セットの加速試験］
［２－２－１．試料の調製］
　まず、試料の調製について説明する。
（１）ジェミーナ配合錠２１錠を、錠剤を格納するポケット（７錠×３列）が形成されたＰＶＣ素材（住友ベークライト株式会社製、VSS-F110-UV-3）のシートに区分収納し、ＰＴＰ用アルミニウム箔（昭北ラミネート工業株式会社製）を用いてシールして、ＰＴＰシートを作成した。このＰＴＰシートと紙製台紙からなるセット１セットを、脱酸素剤（三菱ガス化学株式会社製、ファーマキープ（登録商標）KD-20）１個と共にガスバリア性を有するアルミ袋に格納し、ヒートシールにより封をし、測定試料とした。
（２）別に、ジェミーナ配合錠１０錠を、錠剤を格納するポケット（５錠×２列）が形成されたＰＶＣ／ＰＶＤＣ素材のシートに区分収納し、ＰＴＰ用アルミニウム箔（昭北ラミネート工業株式会社製）を用いてシールしたＰＴＰシートを作成し、参考例取得用の試料とした（アルミ袋への収納を行わず、ＰＴＰシートそのものを、下記の実験に供した）。 [2-2. Accelerated test of drug set using PVC material base sheet]
[2-2-1. Sample preparation]
First, the preparation of the sample will be described.
(1) 21 Gemina combination tablets are separately stored in a sheet of PVC material (VSS-F110-UV-3, manufactured by Sumitomo Bakelite Co., Ltd.) in which pockets (7 tablets x 3 rows) for storing tablets are formed. A PTP sheet was prepared by sealing with an aluminum foil for PTP (manufactured by Shohoku Laminate Industry Co., Ltd.). A set consisting of this PTP sheet and a paper mount is stored in an aluminum bag with gas barrier properties together with one oxygen scavenger (Mitsubishi Gas Chemical Company, Pharmakeep (registered trademark) KD-20) and heat-sealed. It was sealed with a sample and used as a measurement sample.
(2) Separately, 10 Gemina combination tablets are separately stored in a PVC / PVDC material sheet having pockets (5 tablets x 2 rows) for storing tablets, and aluminum foil for PTP (Shokita Laminate Industry Co., Ltd.). A sealed PTP sheet was prepared using (manufactured by) and used as a sample for obtaining a reference example (the PTP sheet itself was used in the following experiment without being stored in an aluminum bag).
［２－２－２．実験方法］
　次に、実験方法について説明する。
　測定試料（ＰＶＣ素材を用いて作成したＰＴＰシートを、紙製台紙及び脱酸素剤と共にアルミ袋に収納したもの、実施例５）及び参考例取得用試料（ＰＶＣ／ＰＶＤＣ素材を用いて作成したＰＴＰシート、参考例２）を、温度４０℃±２℃、湿度７５％RH±５％RHの恒温器に入れ、開始時、保存1カ月、保存3カ月、保存6カ月におけるエチニルエストラジオールの定量を行い、エチニルエストラジオールの含量変化を調べた。
　測定は、それぞれ3ロットの試料を用いて行い、エチニルエストラジオールの定量は、下記の方法を用いて行った。 [2-2-2. experimental method]
Next, the experimental method will be described.
Measurement sample (PTP sheet prepared using PVC material stored in an aluminum bag together with a paper mount and oxygen scavenger, Example 5) and reference example acquisition sample (PTP prepared using PVC / PVDC material) Place the sheet and Reference Example 2) in a thermostat at a temperature of 40 ° C ± 2 ° C and a humidity of 75% RH ± 5% RH, and quantify ethinyl estradiol at the start, storage for 1 month, storage for 3 months, and storage for 6 months. , The change in the content of ethinyl estradiol was investigated.
The measurement was performed using 3 lots of each sample, and the quantification of ethinyl estradiol was performed using the following method.
　エチニルエストラジオールの定量方法を以下に説明する。
（１）錠剤１個に対し、アセトニトリル／水混液（１１：９）１０ｍLで振とう抽出し、孔径０．４５μｍのメンブランフィルターでろ過した液を、試料溶液とした。調製した試料溶液につき、下記の条件によるHPLC分析を行い、エチニルエストラジオールのピーク面積を求め、エチニルエストラジオール標準物質による分析結果との比較に基づき、エチニルエストラジオールの含量を求めた。
（２）以下は、定量の条件である。
　検出器：蛍光光度計（励起波長：２８１nm、検出波長：３０５nm）
　カラム：オクタデシルシリル化シリカゲル（５μm）、内径４．６mm、長さ１５cm
　カラム温度：４０℃付近
　移動相：アセトニトリル／水混液（１１：９）
　流量：１ｍL/分
　注入量：２０μL The method for quantifying ethinyl estradiol will be described below.
(1) One tablet was extracted by shaking with 10 mL of an acetonitrile / water mixed solution (11: 9), and the solution filtered through a membrane filter having a pore size of 0.45 μm was used as a sample solution. The prepared sample solution was subjected to HPLC analysis under the following conditions to determine the peak area of ethinyl estradiol, and the content of ethinyl estradiol was determined based on the comparison with the analysis results using the ethinyl estradiol standard substance.
(2) The following are quantitative conditions.
Detector: Fluorometer (excitation wavelength: 281 nm, detection wavelength: 305 nm)
Column: Octadecylsilylated silica gel (5 μm), inner diameter 4.6 mm, length 15 cm
Column temperature: Around 40 ° C Mobile phase: Acetonitrile / water mixture (11: 9)
Flow rate: 1 mL / min Injection volume: 20 μL
［２－２－３．結果］
　結果を、図６に示す。図６は、４０℃保存におけるエチニルエストラジオール（ＥＥ）の含量変化を示す。グラフＰＶＣNo.1～3は、実施例５の結果を示し、グラフＰＶＣ／ＰＶＤＣNo.1～3は、参考例２の結果を示す。脱酸素剤と共にアルミ袋に収納した試料（測定試料、実施例５）では、６カ月にわたってほとんどエチニルエストラジオールの減少は確認されず、極めて安定であることが確認された。一方、ＰＶＣ／ＰＶＤＣ素材のＰＴＰに格納したＰＴＰシートをアルミ袋に入れずに保存した試料（参考例取得用試料、参考例２）では、６カ月間で約９％のエチニルエストラジオールの減少が確認された。
　この結果から、ＰＶＣ素材のＰＴＰシートに格納し、脱酸素剤と共にガスバリア性のアルミ袋に収納することにより、エチニルエストラジオールの減少を、効果的に抑えることができることが確認された。 [2-2-3. result]
The results are shown in FIG. FIG. 6 shows the change in the content of ethinyl estradiol (EE) when stored at 40 ° C. Graphs PVC Nos. 1 to 3 show the results of Example 5, and graphs PVC / PVCC Nos. 1 to 3 show the results of Reference Example 2. In the sample (measurement sample, Example 5) stored in an aluminum bag together with the oxygen scavenger, almost no decrease in ethinyl estradiol was confirmed over 6 months, and it was confirmed that the sample was extremely stable. On the other hand, in the sample in which the PTP sheet stored in the PVC / PVDC material PTP was stored without being put in an aluminum bag (reference example acquisition sample, reference example 2), a decrease of about 9% in ethinyl estradiol was confirmed in 6 months. Was done.
From this result, it was confirmed that the decrease of ethinyl estradiol can be effectively suppressed by storing it in a PTP sheet made of PVC material and storing it in a gas barrier aluminum bag together with an oxygen scavenger.
［３．変形例］
　上記表１の検証結果において、素材別に比較すると、ＰＶＣ／ＰＶＤＣ素材を用いて作成したＰＴＰシート（比較例１，実施例１，実施例２）を用いることが好ましく、ＰＶＣ素材を用いて作成したＰＴＰシート（実施例３，実施例４）を用いることがより好ましいことが確認された。 [3. Modification example]
In the verification results of Table 1 above, when compared by material, it is preferable to use a PTP sheet (Comparative Example 1, Example 1, Example 2) prepared using a PVC / PVCC material, and the PVC material was used. It was confirmed that it is more preferable to use the PTP sheet (Examples 3 and 4).
　素材の異なるＰＴＰシートに区分収納されたＥＥの分解の抑制及びＥＥの減少に差が生じた原因としては、例えば、ＰＴＰシート３０の基材シート３１のポケット部３１ａに残存する酸素によってＥＥの分解が起こり得るが、ＰＶＤＣと比較してガスバリア性の低いＰＶＣ素材を用いることによって、ポケット部３１ａ内の酸素が効果的にポケット部３１ａ外へ排出されたことが考えられる。 The cause of the difference in the suppression of decomposition of EE and the reduction of EE separately stored in PTP sheets made of different materials is, for example, the decomposition of EE by oxygen remaining in the pocket portion 31a of the base sheet 31 of the PTP sheet 30. However, it is considered that oxygen in the pocket portion 31a is effectively discharged to the outside of the pocket portion 31a by using a PVC material having a lower gas barrier property as compared with PVDC.
　上記表１の検証結果において、素材に応じて結果に違いがあるものの、参考例１とそれ以外とを比較すると、ＰＴＰシートに区分収納して脱酸素剤入りのアルミ袋に収納することで、ＰＶＣ素材及びＰＶＣ／ＰＶＤＣ素材の両方において、ＥＥの減少の抑制に一定の効果が得られることが確認された。 In the verification results in Table 1 above, although the results differ depending on the material, comparing Reference Example 1 with the others, it is possible to store them separately in a PTP sheet and store them in an aluminum bag containing an oxygen scavenger. It was confirmed that a certain effect was obtained in suppressing the decrease in EE in both the PVC material and the PVC / PVDC material.
　基材シート３１は、ポリ塩化ビニルとポリ塩化ビニリデンとの複合体（ＰＶＣ／ＰＶＤＣ）で構成されることも考えられる。ＰＶＤＣは、防湿性及びガスバリア性に優れているため、ＰＶＣ／ＰＶＤＣ素材のＰＴＰシートを用いることで、外袋２内の湿気及び紙製台紙３４の湿気が薬剤に吸収されることを防止でき、外袋２内の酸素がポケット部３１ａに侵入することを防止することができる。ただし、上記の通り、ＰＶＣ／ＰＶＤＣ素材を用いて基材シート３１を作成する場合には、ＰＶＤＣのガスバリア性の高さを考慮して、薬剤Ｍを収納した後に蓋フィルム３２で密閉する前に、ポケット部３１ａ内の空気を不活性ガス（窒素やアルゴン等）で置換することが好ましいと考えられる。基材シート３１の両面を蓋フィルム３２の素材、例えば、アルミ箔の単層で作成する場合も同様である。 It is also conceivable that the base material sheet 31 is composed of a composite (PVC / PVDC) of polyvinyl chloride and polyvinylidene chloride. Since PVDC is excellent in moisture resistance and gas barrier property, by using a PTP sheet made of PVC / PVDC material, it is possible to prevent the moisture in the outer bag 2 and the moisture in the paper mount 34 from being absorbed by the chemicals. It is possible to prevent the oxygen in the outer bag 2 from entering the pocket portion 31a. However, as described above, when the base sheet 31 is prepared using the PVC / PVDC material, in consideration of the high gas barrier property of the PVDC, after storing the drug M and before sealing with the lid film 32. It is considered preferable to replace the air in the pocket portion 31a with an inert gas (nitrogen, argon, etc.). The same applies to the case where both sides of the base sheet 31 are made of the material of the lid film 32, for example, a single layer of aluminum foil.
　なお、薬剤セットのさらに別の実施形態としては、酸素により劣化する成分を含む薬剤が区分収納されたガスバリア性素材のＰＴＰシートと、前記ＰＴＰシートを収容するガスバリア性素材の外袋と、を備え、前記ＰＴＰシートは、低酸素状態で前記薬剤を区分収納している構成であってもよい。例えば、当該薬剤セットは、ＰＶＣ／ＰＶＤＣ素材等の酸素透過性の低い（もしくは酸素不透過性の）素材によるＰＴＰシートを用いてもよく、シール時にポケット内の空気を不活性ガスで置換することで低酸素状態を実現してもよい。さらに、当該薬剤セットのＰＴＰシートは、防湿機能を有してもよい。これらの態様において、ＰＴＰシートをガスバリア性の外袋に収納してヒートシールする際に、当該外袋内の空気を脱気もしくは不活性ガスで置換する等して、酸素を除去することが好ましい。また、紙製台紙と共に外袋内に収納する場合には、乾燥剤や脱酸素剤を同梱しても良い。 As yet another embodiment of the drug set, a PTP sheet made of a gas barrier material containing a drug containing a component deteriorated by oxygen is provided, and an outer bag made of a gas barrier material containing the PTP sheet. The PTP sheet may be configured to separately store the drug in a low oxygen state. For example, the drug set may use a PTP sheet made of a material having low oxygen permeability (or oxygen impermeable) such as PVC / PVDC material, and the air in the pocket may be replaced with an inert gas at the time of sealing. May realize a hypoxic state. Further, the PTP sheet of the drug set may have a moisture-proof function. In these embodiments, when the PTP sheet is stored in a gas barrier outer bag and heat-sealed, it is preferable to remove oxygen by degassing or replacing the air in the outer bag with an inert gas. .. In addition, when storing in the outer bag together with the paper mount, a desiccant or oxygen scavenger may be included.
［４．その他］
　本実施形態では、外袋２はジップ２５を有しているが、ジップ２５は無くてもよい。また、本実施形態では、外袋２に同梱する携行用パッケージ３を１つ示しているが、その数は複数であってもよい。また、本実施形態では、脱酸素剤４は、携行用パッケージ３とともに外袋２に別々に同封されているが、携行用保護ケース３３の紙製台紙３４の任意の箇所に貼り付けてもよい。あるいは、脱酸素剤４を第１の挟持片３７及び第２の挟持片３８の間に挿入してもよい。これにより、携行用パッケージ３を外袋２から取り出した場合にも酸素吸収機能及び吸湿機能が発揮されるため、薬剤中のＥＥの分解をより抑制することができ、薬剤の品質の安定化を図ることができる。 [4. others]
In the present embodiment, the outer bag 2 has the zip 25, but the zip 25 may not be present. Further, in the present embodiment, one carrying package 3 included in the outer bag 2 is shown, but the number may be plural. Further, in the present embodiment, the oxygen scavenger 4 is separately enclosed in the outer bag 2 together with the carrying package 3, but may be attached to any position on the paper mount 34 of the carrying protective case 33. .. Alternatively, the oxygen scavenger 4 may be inserted between the first holding piece 37 and the second holding piece 38. As a result, even when the carrying package 3 is taken out from the outer bag 2, the oxygen absorption function and the moisture absorption function are exhibited, so that the decomposition of EE in the drug can be further suppressed and the quality of the drug can be stabilized. Can be planned.
　さらに、上記実施形態においては、基材シート３１としてポリ塩化ビニル（ＰＶＣ）及びポリ塩化ビニル及びポリ塩化ビニリデンの複合体（ＰＶＣ／ＰＶＤＣ）を示したが、所望の性能に応じて、基材シート３１として当業界で公知の熱可塑性樹脂、例えばポリプロピレン、ポリエチレンテレフタレートなどを用いることができる。 Further, in the above embodiment, polyvinyl chloride (PVC) and a composite of polyvinyl chloride and polyvinylidene chloride (PVC / PVDC) are shown as the base sheet 31, but the base sheet can be used depending on the desired performance. As 31, a thermoplastic resin known in the art, for example, polypropylene, polyethylene terephthalate, or the like can be used.
　また、ＰＴＰシート３０のポケット部３１ａ及び第１及び第２の挟持片３７，３８の孔３７ａ，３８ａの設置個数や配列は、薬剤の用法・用量、意匠性、取扱性などを考慮して適宜変更することができる。例えば、７ｘ４の配列としたり千鳥状に配列したりしてもよい。 Further, the number and arrangement of the pocket portions 31a of the PTP sheet 30 and the holes 37a, 38a of the first and second holding pieces 37, 38 are appropriately determined in consideration of the usage / dose, designability, handleability, etc. of the drug. Can be changed. For example, it may be arranged in a 7x4 arrangement or in a staggered manner.
　また、ＰＴＰシート３０のポケット部３１ａの設置個数は、例えば用法・用量に適合させて２～３１としてもよい。例えば、1週間分として７個のポケット部３１ａを一列に配し、７個×４列や７個×３列とすると、服薬管理上も便利であり、好ましい。この場合、孔３７ａ，３８ａの設置個数や配列は、ＰＴＰシート３０のポケット部３１ａと同様にすればよい。さらに、ＰＴＰシート３０のポケット部３１ａの設置個数よりも、孔３７ａ，３８ａの設置個数を多くしてもよく、この場合、携行用保護ケース３３を、ポケット部３１ａの設置個数が異なる多種のＰＴＰシート３０で共通使用できるようになる。 Further, the number of pocket portions 31a of the PTP sheet 30 may be set to 2 to 31 according to the usage and dosage, for example. For example, if seven pocket portions 31a are arranged in a row for one week and the number is 7 × 4 rows or 7 × 3 rows, it is convenient for medication management and is preferable. In this case, the number and arrangement of the holes 37a and 38a may be the same as those of the pocket portion 31a of the PTP sheet 30. Further, the number of holes 37a and 38a to be installed may be larger than the number of pockets 31a of the PTP sheet 30 to be installed. In this case, the carrying protective case 33 and various PTPs having different number of pockets 31a are installed. The sheet 30 can be used in common.
　本実施形態では、脱酸素剤４は袋状であるが、これに限られず、キャニスタータイプのものや、シート状やフィルム状のものであってもよい。シート状の場合には、携行用パッケージ３とともに外袋２に封入しやすい。 In the present embodiment, the oxygen scavenger 4 is in the form of a bag, but is not limited to this, and may be in the form of a canister, a sheet, or a film. In the case of a sheet, it is easy to enclose it in the outer bag 2 together with the carrying package 3.
１　　　薬剤セット
２　　　外袋
３　　　携行用パッケージ
４　　　脱酸素剤
２０　　内部空間
２１　　シール部
２２　　開口予定部
２３　　破断線
２４　　開口部
２５　　ジップ
３０　　ＰＴＰシート
３１　　基材シート
３１ａ　ポケット部
３２　　蓋フィルム
３３　　携行用保護ケース
３４　　紙製台紙
３５　　表紙片
３６　　背表紙片
３７　　第１の挟持片
３７ａ　孔
３８　　第２の挟持片
３８ａ　孔
３９　　粘着剤
Ｍ　　　薬剤（錠剤）
  1 Drug set 2 Outer bag 3 Carrying package 4 Oxygen scavenger 20 Internal space 21 Seal part 22 Scheduled opening part 23 Break line 24 Opening part 25 Zip 30 PTP sheet 31 Base material sheet 31a Pocket part 32 Cover film 33 Carrying protective case 34 Paper mount 35 Cover piece 36 Back cover piece 37 First holding piece 37a Hole 38 Second holding piece 38a Hole 39 Adhesive M Drug (tablet)

Claims (6)

  1. 　酸素により劣化する成分を含む薬剤が区分収納されたＰＴＰシートと、
    　脱酸素剤と、
    　前記脱酸素剤を前記ＰＴＰシートとともに収容するガスバリア性素材の外袋と、
    を備えて構成された、薬剤セット。     A PTP sheet in which chemicals containing components that are deteriorated by oxygen are stored separately,
    Oxygen scavenger and
    An outer bag made of a gas barrier material that houses the oxygen scavenger together with the PTP sheet,
    A drug set that is configured with.
  2. 　前記ＰＴＰシートは、酸素透過性を有する素材により構成されている、請求項１に記載の薬剤セット。 The drug set according to claim 1, wherein the PTP sheet is made of a material having oxygen permeability.
  3. 　前記ＰＴＰシートは、ポリ塩化ビニル又はポリ塩化ビニルとポリ塩化ビニリデンとの複合体により構成されている、請求項２に記載の薬剤セット。 The drug set according to claim 2, wherein the PTP sheet is composed of polyvinyl chloride or a complex of polyvinyl chloride and polyvinylidene chloride.
  4. 　前記脱酸素剤は、吸湿機能を有する、請求項１～３のいずれか一項に記載の薬剤セット。 The drug set according to any one of claims 1 to 3, wherein the oxygen scavenger has a hygroscopic function.
  5. 　前記ＰＴＰシートは、紙製の台紙とともに前記外袋に収容されている、請求項１～４のいずれか一項に記載の薬剤セット。 The drug set according to any one of claims 1 to 4, wherein the PTP sheet is housed in the outer bag together with a paper mount.
  6. 　前記ＰＴＰシートは、前記紙製の台紙に装着された状態で前記外袋に収容されている、請求項５に記載の薬剤セット。
          The drug set according to claim 5, wherein the PTP sheet is housed in the outer bag in a state of being attached to the paper mount.
PCT/JP2021/027865 2020-07-29 2021-07-28 Medicine set WO2022025103A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022539522A JPWO2022025103A1 (en) 2020-07-29 2021-07-28

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020128530 2020-07-29
JP2020-128530 2020-07-29

Publications (1)

Publication Number Publication Date
WO2022025103A1 true WO2022025103A1 (en) 2022-02-03

Family

ID=80035705

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/027865 WO2022025103A1 (en) 2020-07-29 2021-07-28 Medicine set

Country Status (3)

Country Link
JP (1) JPWO2022025103A1 (en)
TW (1) TWI800878B (en)
WO (1) WO2022025103A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11322605A (en) * 1998-05-07 1999-11-24 Pola Chem Ind Inc Pharmaceutical preparation containing dopamine uptake inhibitor
JP2005103148A (en) * 2003-10-01 2005-04-21 Nisshin Kyorin Pharmaceutical Co Ltd Method and system for preserving 5-aminosalicylic acid
JP2016068961A (en) * 2014-09-26 2016-05-09 ノーベルファーマ株式会社 Portable drug set

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009143591A (en) * 2007-12-13 2009-07-02 Toppan Printing Co Ltd Ptp package
JP5942405B2 (en) * 2011-12-07 2016-06-29 住友ベークライト株式会社 Tablet packaging
TWI623310B (en) * 2014-07-30 2018-05-11 泰爾茂股份有限公司 Packaged acetaminophen injection solution preparation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11322605A (en) * 1998-05-07 1999-11-24 Pola Chem Ind Inc Pharmaceutical preparation containing dopamine uptake inhibitor
JP2005103148A (en) * 2003-10-01 2005-04-21 Nisshin Kyorin Pharmaceutical Co Ltd Method and system for preserving 5-aminosalicylic acid
JP2016068961A (en) * 2014-09-26 2016-05-09 ノーベルファーマ株式会社 Portable drug set

Also Published As

Publication number Publication date
TW202218650A (en) 2022-05-16
JPWO2022025103A1 (en) 2022-02-03
TWI800878B (en) 2023-05-01

Similar Documents

Publication Publication Date Title
US20110240511A1 (en) Packaging for oxygen-sensitive pharmaceutical products
US20070163917A1 (en) Package and device for simultaneously maintaining low moisture and low oxygen levels
JP5030952B2 (en) Drug packaging material and drug packaging bag
JP5056754B2 (en) container
US20020132359A1 (en) Dispensing unit for oxygen-sensitive drugs
US20060076536A1 (en) Oxygen scavenging pharmaceutical package and methods for making same
JP6060148B2 (en) Tablet packaging device and packaging bag
BR112015022171B1 (en) PHARMACEUTICAL PACKAGING SYSTEM FOR AN INJECTED OXYGEN SENSITIVE DRUG
WO2016204293A1 (en) Laminate for use in blister pack, and blister pack using same
JP2011042371A (en) Ptp package
WO2022025103A1 (en) Medicine set
US11337890B2 (en) Packaging assembly and container for same, method of making a packaging assembly, and associated method of activating an active agent
US20130193007A1 (en) Packaging and methods of packaging particulate solids
US20050020554A1 (en) Stability of hormone formulations
JP2010280403A (en) Laminated packaging bag
JP6449517B1 (en) Carrying drug set
JP7252592B2 (en) packaging material
JP6419505B2 (en) Carrying drug set
JPH10236541A (en) Multiple-compartment container
JP2020011737A (en) Packaging bag
JP2019038615A (en) Portable drug set
JPH10236538A (en) Multiple-compartment container
JP6225634B2 (en) Bag body and method for manufacturing bag body
JP2023524638A (en) Packages configured to preserve products or inhibit pathogens on products, and methods of making and using at least a portion thereof
JPH0350049Y2 (en)

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21848987

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022539522

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21848987

Country of ref document: EP

Kind code of ref document: A1