JP7069042B2 - 貼付剤 - Google Patents
貼付剤 Download PDFInfo
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- JP7069042B2 JP7069042B2 JP2018559525A JP2018559525A JP7069042B2 JP 7069042 B2 JP7069042 B2 JP 7069042B2 JP 2018559525 A JP2018559525 A JP 2018559525A JP 2018559525 A JP2018559525 A JP 2018559525A JP 7069042 B2 JP7069042 B2 JP 7069042B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Materials For Medical Uses (AREA)
Description
以下の例において、別段の記載がない限り、貼付剤は次のように調製した。
1)粘着剤層の各成分を混和し、剥離フィルム(離型処理をしたPETフィルム)上に塗布した。これを乾燥させることでDMSOを所定量まで除去し、厚み100μmの粘着剤層(100g/m2)を形成した。
2)粘着剤層上に支持体層を積層し、貼付剤を得た。貼付剤は適当な大きさに適宜裁断した。
以下の例において、使用した支持体層の透湿度は、JIS Z0208に準じて、40℃、90%RHの測定条件で測定した。
以下の例において、別段の記載がない限り、貼付剤の粘着性は、次に示す180°剥離試験により評価した。
1)貼付剤から1cm×5cmの試験片を準備し、所定条件で所定時間保存した。
2)試験片から剥離フィルムを除去し、試験片をステンレス板に貼付した。
3)インストロン型引張試験機を用いて、試験片を30cm/分の速度でステンレス板から180°の方向に引き剥がし、剥離力(gF/cm)を測定した。
4)定常な剥離を示した区間での剥離力の積分値から、平均の剥離力(gF/cm)を算出した。高い剥離力は、優れた粘着性を意味する。
以下の例において、貼付剤の皮膚への付着性は、次に示す方法により評価した。被験者の皮膚に貼付剤を貼付した。24時間後、貼付剤の付着の程度を目視で観察した。貼付剤の面積の90%以上が皮膚に付着している状態である場合を「A」、それ以外の場合を「B」として評価した。
表1に示す構成の貼付剤(プラセボ貼付剤)を調製した。表中、「PETフィルム」、「PETフィルム/PET不織布」、「PUフィルム/PU不織布」、及び「PET編布」とは、それぞれ、PETからなるフィルム、PETからなるフィルムとPET繊維からなる不織布との積層体、PUからなるフィルムとPU繊維からなる不織布との積層体、及びPETからなる編布を意味する。また、表1におけるゴム系粘着剤は、SISブロック共重合体とPIBの混合物であって、SISブロック共重合体とPIBを19:7の質量比で含む。「PET編布」としては、透湿度が5667g/m2・24時間であり、縦方向の50%モジュラスが3.9N/50mmであり、かつ横方向の50%モジュラスが3.4N/50mmであるものを使用した(以下の例において同じ)。貼付剤を、30℃、65%RHのインキュベーター内に、支持体層が上向きになり、剥離フィルムが下向きになるように配置し、保存した。24時間後、貼付剤からDMSOを抽出し、GCにより定量した。この保存条件は、貼付剤を皮膚に24時間貼付した場合の環境を模した条件である。
表2に示す構成の貼付剤を調製した。表2におけるゴム系粘着剤は、SISブロック共重合体とPIBの混合物であって、SISブロック共重合体とPIBを19:7の質量比で含む。実施例2、7~9の貼付剤の粘着性を、ASTM D2979のプローブタック試験方法に準じて以下の条件で測定したプローブタック値により評価した。高いプローブタック値は、優れた粘着性を意味する。
試験機:タッキング試験機(レスカ)
プローブ部先端材質:ステンレス
接着面の直径:5mm
引離し速度:2mm/秒
接着荷重:200gF/cm2
接着時間:1秒
表3に示す構成の貼付剤を調製した。表3に示す構成の貼付剤について、試験例2と同様の方法でプローブタック値を測定し、粘着性を評価した。表3におけるゴム系粘着剤は、SISブロック共重合体とPIBの混合物であって、SISブロック共重合体とPIBを19:7の質量比で含む。表3における「ゴム/ポリエステル布」とは、ゴム組成物でコーティングされたポリエステルの布を意味する。実施例16の貼付剤におけるPUフィルム(透湿度786g/m2・24時間)、並びに、実施例17、19及び20の貼付剤におけるPUフィルム(透湿度8408g/m2・24時間)は、それぞれ3M社の「3M CoTran 9701 Backing」及び「3M CoTran 9700」である。
Claims (6)
- 支持体層と支持体層上に積層された粘着剤層とを備え、
支持体層の透湿度が400g/m2・24時間以上であり、かつ、支持体層の縦方向及び横方向の50%モジュラスが1N/50mm~12N/50mmであり、
粘着剤層が、薬物と、ジメチルスルホキシドと、ゴム系粘着剤とを含み、
ジメチルスルホキシドの含有量が、粘着剤層の全質量に対して1質量%~15質量%である、貼付剤。 - 支持体層の透湿度が750g/m2・24時間以上である、請求項1に記載の貼付剤。
- 支持体層の透湿度が2000g/m2・24時間以上である、請求項1に記載の貼付剤。
- 粘着剤層が、スチレン-イソプレン-スチレンブロック共重合体を含む、請求項1~3のいずれか一項に記載の貼付剤。
- 薬物が、ケトプロフェン、ジクロフェナクナトリウム、及びインドメタシンからなる群より選択される1種以上の薬物である、請求項1~4のいずれか一項に記載の貼付剤。
- 粘着剤層がさらに有機酸を含む、請求項5に記載の貼付剤。
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2022002170A JP7366166B2 (ja) | 2016-12-28 | 2022-01-11 | 貼付剤 |
JP2023174989A JP2023184531A (ja) | 2016-12-28 | 2023-10-10 | 貼付剤 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2016256702 | 2016-12-28 | ||
JP2016256702 | 2016-12-28 | ||
PCT/JP2017/046697 WO2018124089A1 (ja) | 2016-12-28 | 2017-12-26 | 貼付剤 |
Related Child Applications (1)
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JP2022002170A Division JP7366166B2 (ja) | 2016-12-28 | 2022-01-11 | 貼付剤 |
Publications (2)
Publication Number | Publication Date |
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JPWO2018124089A1 JPWO2018124089A1 (ja) | 2019-10-31 |
JP7069042B2 true JP7069042B2 (ja) | 2022-05-17 |
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JP2018559525A Active JP7069042B2 (ja) | 2016-12-28 | 2017-12-26 | 貼付剤 |
JP2022002170A Active JP7366166B2 (ja) | 2016-12-28 | 2022-01-11 | 貼付剤 |
JP2023174989A Pending JP2023184531A (ja) | 2016-12-28 | 2023-10-10 | 貼付剤 |
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JP2022002170A Active JP7366166B2 (ja) | 2016-12-28 | 2022-01-11 | 貼付剤 |
JP2023174989A Pending JP2023184531A (ja) | 2016-12-28 | 2023-10-10 | 貼付剤 |
Country Status (8)
Country | Link |
---|---|
US (2) | US11020356B2 (ja) |
EP (1) | EP3563840B1 (ja) |
JP (3) | JP7069042B2 (ja) |
KR (1) | KR102358377B1 (ja) |
CN (1) | CN110114064A (ja) |
ES (1) | ES2893527T3 (ja) |
TW (1) | TWI743283B (ja) |
WO (1) | WO2018124089A1 (ja) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2022519317A (ja) | 2019-02-06 | 2022-03-22 | ベンセラ,インコーポレイティド | 局所ホスホイノシチド3-キナーゼ阻害剤 |
JP7124201B2 (ja) * | 2019-02-27 | 2022-08-23 | 久光製薬株式会社 | 貼付剤 |
JP6744511B1 (ja) * | 2020-02-12 | 2020-08-19 | 久光製薬株式会社 | ジクロフェナクナトリウム含有貼付剤 |
JP6761553B1 (ja) * | 2020-02-12 | 2020-09-23 | 久光製薬株式会社 | ジクロフェナクナトリウム含有貼付剤 |
JP6744512B1 (ja) * | 2020-02-12 | 2020-08-19 | 久光製薬株式会社 | ジクロフェナクナトリウム含有貼付剤 |
WO2022031729A1 (en) * | 2020-08-04 | 2022-02-10 | Venthera, Inc. | Formulations of phosphoinositide 3-kinase inhibitors |
US11872320B2 (en) * | 2021-02-25 | 2024-01-16 | Hisamitsu Pharmaceutical Co., Inc. | Method for treating osteoarthritis |
Citations (6)
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WO2009096315A1 (ja) | 2008-01-31 | 2009-08-06 | Hisamitsu Pharmaceutical Co., Inc. | 貼付剤 |
WO2010137699A1 (ja) | 2009-05-29 | 2010-12-02 | 株式会社イノアック技術研究所 | 貼付材 |
JP2011162514A (ja) | 2010-02-12 | 2011-08-25 | Hisamitsu Pharmaceut Co Inc | 経皮吸収製剤並びにその製造方法 |
WO2011136330A1 (ja) | 2010-04-30 | 2011-11-03 | ニチバン株式会社 | 貼付剤とその使用 |
WO2013191128A1 (ja) | 2012-06-20 | 2013-12-27 | 久光製薬株式会社 | 貼付剤 |
WO2014148582A1 (ja) | 2013-03-21 | 2014-09-25 | ニチバン株式会社 | 無溶剤型のポリウレタン系粘着剤 |
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CN1047732C (zh) * | 1995-04-10 | 1999-12-29 | 浙江省医学科学院 | 石杉碱透皮吸收贴片 |
US5702720A (en) | 1995-12-22 | 1997-12-30 | Minnesota Mining And Manufacturing Company | Transdermal device for the delivery of flurbiprofen |
JPH11322590A (ja) | 1998-05-13 | 1999-11-24 | Teijin Ltd | 新規粘着剤及び貼付製剤 |
AU1436402A (en) * | 2000-11-06 | 2002-05-15 | Samyang Corp | Transdermal drug delivery system with improved water absorbability and adhesion properties |
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WO2004047820A1 (ja) * | 2002-11-27 | 2004-06-10 | Hisamitsu Pharmaceutical Co., Inc. | 温感パップ剤 |
GB2396109B (en) * | 2002-12-12 | 2006-04-19 | Johnson & Johnson Medical Ltd | Absorbent multilayer hydrogel wound dressings |
WO2004058232A1 (ja) | 2002-12-26 | 2004-07-15 | Kowa Co., Ltd. | 貼付剤 |
KR100682729B1 (ko) * | 2004-06-15 | 2007-02-15 | (주)아모레퍼시픽 | 신규 경피흡수제제 및 그 제조방법 |
JP2006288887A (ja) | 2005-04-13 | 2006-10-26 | Nitto Denko Corp | 貼付製剤 |
JP2007015963A (ja) | 2005-07-06 | 2007-01-25 | Hisamitsu Pharmaceut Co Inc | 貼付剤 |
BRPI0712396B8 (pt) * | 2006-08-04 | 2021-05-25 | Hisamitsu Pharmaceutical Co | preparação de adesivo que compreende um suporte estirável e uma camada de adesivo laminada |
EP2196197A1 (en) | 2008-12-15 | 2010-06-16 | Bouty S.P.A. | Antiviral patch |
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JP5307931B1 (ja) * | 2012-12-27 | 2013-10-02 | 久光製薬株式会社 | 貼付剤及びその製造方法 |
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- 2017-12-26 US US16/474,213 patent/US11020356B2/en active Active
- 2017-12-26 KR KR1020197017157A patent/KR102358377B1/ko active IP Right Grant
- 2017-12-26 CN CN201780080620.2A patent/CN110114064A/zh active Pending
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Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2009096315A1 (ja) | 2008-01-31 | 2009-08-06 | Hisamitsu Pharmaceutical Co., Inc. | 貼付剤 |
WO2010137699A1 (ja) | 2009-05-29 | 2010-12-02 | 株式会社イノアック技術研究所 | 貼付材 |
JP2011162514A (ja) | 2010-02-12 | 2011-08-25 | Hisamitsu Pharmaceut Co Inc | 経皮吸収製剤並びにその製造方法 |
WO2011136330A1 (ja) | 2010-04-30 | 2011-11-03 | ニチバン株式会社 | 貼付剤とその使用 |
WO2013191128A1 (ja) | 2012-06-20 | 2013-12-27 | 久光製薬株式会社 | 貼付剤 |
WO2014148582A1 (ja) | 2013-03-21 | 2014-09-25 | ニチバン株式会社 | 無溶剤型のポリウレタン系粘着剤 |
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JP7366166B2 (ja) | 2023-10-20 |
US11020356B2 (en) | 2021-06-01 |
EP3563840A1 (en) | 2019-11-06 |
WO2018124089A1 (ja) | 2018-07-05 |
TW201828931A (zh) | 2018-08-16 |
ES2893527T3 (es) | 2022-02-09 |
US20210251913A1 (en) | 2021-08-19 |
EP3563840A4 (en) | 2020-07-29 |
KR20190085972A (ko) | 2019-07-19 |
CN110114064A (zh) | 2019-08-09 |
US20190350874A1 (en) | 2019-11-21 |
JPWO2018124089A1 (ja) | 2019-10-31 |
TWI743283B (zh) | 2021-10-21 |
EP3563840B1 (en) | 2021-09-01 |
JP2023184531A (ja) | 2023-12-28 |
KR102358377B1 (ko) | 2022-02-03 |
JP2022036194A (ja) | 2022-03-04 |
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