WO2022025103A1 - Ensemble de médicaments - Google Patents

Ensemble de médicaments Download PDF

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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
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WO
WIPO (PCT)
Prior art keywords
ptp sheet
oxygen
drug
sheet
outer bag
Prior art date
Application number
PCT/JP2021/027865
Other languages
English (en)
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/fr

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    • 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.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)

Abstract

La présente invention améliore la stabilité d'un médicament par suppression de la dégradation de l'oxygène d'un composant qui est mélangé dans le médicament et est détérioré par l'oxygène. Un ensemble de médicaments (1) selon la présente invention est conçu pour comprendre une feuille PTP dans laquelle des médicaments qui contiennent un composant qui est détérioré par l'oxygène sont contenus séparément, un agent de désoxygénation (4), et un emballage externe (2) qui contient l'agent de désoxygénation (4) conjointement avec la feuille de PTP, ledit emballage externe (2) étant constitué d'un matériau barrière aux gaz.
PCT/JP2021/027865 2020-07-29 2021-07-28 Ensemble de médicaments WO2022025103A1 (fr)

Priority Applications (1)

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

Applications Claiming Priority (2)

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

Publications (1)

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

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PCT/JP2021/027865 WO2022025103A1 (fr) 2020-07-29 2021-07-28 Ensemble de médicaments

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JP (1) JPWO2022025103A1 (fr)
TW (1) TWI800878B (fr)
WO (1) WO2022025103A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11322605A (ja) * 1998-05-07 1999-11-24 Pola Chem Ind Inc ドパミン取り込み阻害剤含有製剤
JP2005103148A (ja) * 2003-10-01 2005-04-21 Nisshin Kyorin Pharmaceutical Co Ltd ５−アミノサリチル酸の保存方法及び保存システム
JP2016068961A (ja) * 2014-09-26 2016-05-09 ノーベルファーマ株式会社 携行用薬剤セット

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009143591A (ja) * 2007-12-13 2009-07-02 Toppan Printing Co Ltd Ｐｔｐ包装体
JP5942405B2 (ja) * 2011-12-07 2016-06-29 住友ベークライト株式会社 錠剤包装体
TWI623310B (zh) * 2014-07-30 2018-05-11 泰爾茂股份有限公司 被包裝的乙醯胺苯酚注射溶液製劑

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11322605A (ja) * 1998-05-07 1999-11-24 Pola Chem Ind Inc ドパミン取り込み阻害剤含有製剤
JP2005103148A (ja) * 2003-10-01 2005-04-21 Nisshin Kyorin Pharmaceutical Co Ltd ５−アミノサリチル酸の保存方法及び保存システム
JP2016068961A (ja) * 2014-09-26 2016-05-09 ノーベルファーマ株式会社 携行用薬剤セット

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TW202218650A (zh) 2022-05-16
JPWO2022025103A1 (fr) 2022-02-03
TWI800878B (zh) 2023-05-01

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