JP2019521781A - 医薬組成物中の凝集体の量を低減するための方法 - Google Patents
医薬組成物中の凝集体の量を低減するための方法 Download PDFInfo
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Classifications
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A—HUMAN NECESSITIES
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Physics & Mathematics (AREA)
- Plasma & Fusion (AREA)
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- Materials For Medical Uses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
バレルの内壁上の前記潤滑剤コーティングの形成中、方法は、バレルの遠位端部から遠位に延びる前記領域内に潤滑剤の堆積するのを制限するステップを含むことを特徴とする、方法を提供する。
−医薬組成物を含むよう意図された容器であって、医薬組成物と接触するよう意図された潤滑剤コーティングで潤滑されたバレルを含む、容器と、
−バレル内で摺動係合するストッパと
を備え、
容器は、ストッパがアクセスできない、バレルの遠端部から遠位に延びる領域を含み、
バレルの遠位端部から遠位に延びる前記領域は、制限された量の潤滑剤を含み、前記制限された量は、25μg未満であり、好ましくは20μg未満である。
最初にHIAC装置をWFIおよびイソプロパノールアルコールの混合物(50/50の割合)で洗浄し、その後WFIのみで洗浄する。
Claims (10)
- 医療注射デバイス内に含まれる医薬組成物内の凝集体の量を低減するための方法であって、前記医薬組成物と接触する潤滑剤コーティング(2)によって潤滑されるバレル(10)を含む容器(1)と、前記バレル(10)内で摺動係合するストッパ(14)とを備え、前記容器は、前記ストッパがアクセスできない、前記バレルの遠位端部(100)から遠位に延びる領域(130、121、123)を含む、方法において、
前記バレルの内壁上の前記潤滑剤コーティング(2)の形成中、前記方法は、前記バレルの前記遠位端部(100)から遠位に延びる前記領域(130、121、123)に潤滑剤の堆積するのを制限するステップを含むことを特徴とする方法。 - 前記潤滑剤は、前記容器の近位端部を通って前記バレルの前記内壁上にノズルによって噴霧され、前記噴霧は、前記バレルの前記遠位端部(100)から遠位に延びる前記領域(130、121、123)内への潤滑剤の堆積を制限するように構成される請求項1に記載の方法。
- 前記ノズル(3)は、前記容器(1)に対して固定される請求項2に記載の方法。
- 前記ノズル(3)は、前記バレル(10)内に動きながら挿入される請求項2に記載の方法。
- 前記潤滑剤の堆積後、前記潤滑剤コーティングを焼きなますステップをさらに含む請求項2乃至4のいずれか一項に記載の方法。
- 前記潤滑剤の堆積後、前記潤滑剤コーティングをプラズマで処理するステップをさらに含む請求項2乃至4のいずれか一項に記載の方法。
- 前記潤滑剤コーティングの形成は、前記バレルの前記内壁上にベクトルガスによって運ばれた前記潤滑剤の化学的前駆体を吸着するステップと、前記化学的前駆体をプラズマで架橋するステップとを含む請求項1に記載の方法。
- 前記バレルの前記遠位端部から遠位に延びる前記領域(130、121、123)内に堆積された潤滑剤の総量は、25μg未満であり、好ましくは20μg未満である請求項1乃至6のいずれか一項に記載の方法。
- 前記潤滑剤は、ポリ−(ジメチルポリシロキサン)またはポリ−(ジメチルポリシロキサン)の乳剤を含む請求項1乃至8のいずれか一項に記載の方法。
- 前記容器は、注入チャネル(121)を備える先端部(120)と、前記注入チャネル(121)内に挿入された中空針(122)とをさらに 備え、前記方法は、前記注入チャネル(121)および前記中空針の前記内側空間(123)内に潤滑剤の堆積するのを制限するステップを含む請求項1乃至9のいずれか一項に記載の方法。
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EP16305874 | 2016-07-11 | ||
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PCT/EP2017/067368 WO2018011190A1 (en) | 2016-07-11 | 2017-07-11 | Method for reducing an amount of subvisible particles in a pharmaceutical composition |
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US (2) | US11628257B2 (ja) |
EP (1) | EP3481467A1 (ja) |
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KR (1) | KR102372106B1 (ja) |
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JP7164997B2 (ja) * | 2018-08-31 | 2022-11-02 | Ntn株式会社 | 塗布針部材、塗布針部材アセンブリ、塗布部材および塗布装置 |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH07280177A (ja) * | 1994-03-28 | 1995-10-27 | Minimed Inc | 注入器の胴部を潤滑するための装置 |
JP2002143300A (ja) * | 2000-07-28 | 2002-05-21 | Carl Zeiss:Fa | 医療用円筒容器の内壁に熱付着性潤滑剤コーティングを施すための方法及び装置 |
JP2014530059A (ja) * | 2011-09-27 | 2014-11-17 | ベクトン ディキンソン フランス | 医療用注射装置においてプラズマ処理したシリコーンオイルのコーティングとしての使用 |
JP2015523422A (ja) * | 2012-05-07 | 2015-08-13 | ベクトン ディキンソン フランス | 医療容器用潤滑性コーティング |
WO2016102068A1 (en) * | 2014-12-23 | 2016-06-30 | Merz Pharma Gmbh & Co. Kgaa | Botulinum toxin prefilled container |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4022206A (en) * | 1975-08-01 | 1977-05-10 | Merck & Co., Inc. | Vaccine delivery system |
DE19753766A1 (de) * | 1997-12-04 | 1999-06-17 | Schott Glas | Länglicher Kunststoff-Hohlkörper und Verfahren zu seiner Herstellung |
US6461334B1 (en) | 1998-03-06 | 2002-10-08 | Novo Nordisk A/S | Medical article with coated surfaces exhibiting low friction and protein adsorption |
JP2004229750A (ja) * | 2003-01-28 | 2004-08-19 | Nipro Corp | プレフィルドシリンジ及びそのバレルの製造方法 |
JP2005160888A (ja) | 2003-12-05 | 2005-06-23 | Terumo Corp | シリンジ用ガスケット、シリンジ及びシリンジ用ガスケットの製造方法 |
EP3505206B1 (en) | 2008-09-22 | 2022-03-16 | Becton, Dickinson and Company | A system for coating the interior of a container using a photolysis chemical vapor deposition process |
KR101704833B1 (ko) * | 2008-12-03 | 2017-02-08 | 덴카 주식회사 | 시린지 |
JP5602754B2 (ja) * | 2009-10-28 | 2014-10-08 | 味の素製薬株式会社 | シリンジとシリンジ本体の製造装置とシリンジ本体の製造方法 |
WO2011092536A1 (en) * | 2010-01-26 | 2011-08-04 | Becton Dickinson France | Drug cartrigde different inner surface conditions |
MX2014013411A (es) * | 2012-05-29 | 2015-10-09 | Becton Dickinson France | Revestimiento lubricante y dispositivo de inyeccion medico que comprende dicho revestimiento. |
US20170182252A1 (en) * | 2014-05-26 | 2017-06-29 | Becton Dickinson France | Method for Storing an Emulsion-Adjuvanted Vaccine in a Lubricated Medical Injection Device |
-
2017
- 2017-07-11 MX MX2019000263A patent/MX2019000263A/es unknown
- 2017-07-11 CN CN202310980324.5A patent/CN116870298A/zh active Pending
- 2017-07-11 KR KR1020197003776A patent/KR102372106B1/ko active IP Right Grant
- 2017-07-11 CN CN201710559852.8A patent/CN107596503A/zh active Pending
- 2017-07-11 US US16/316,736 patent/US11628257B2/en active Active
- 2017-07-11 JP JP2019500789A patent/JP7042792B2/ja active Active
- 2017-07-11 WO PCT/EP2017/067368 patent/WO2018011190A1/en unknown
- 2017-07-11 EP EP17737283.6A patent/EP3481467A1/en active Pending
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Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH07280177A (ja) * | 1994-03-28 | 1995-10-27 | Minimed Inc | 注入器の胴部を潤滑するための装置 |
JP2002143300A (ja) * | 2000-07-28 | 2002-05-21 | Carl Zeiss:Fa | 医療用円筒容器の内壁に熱付着性潤滑剤コーティングを施すための方法及び装置 |
JP2014530059A (ja) * | 2011-09-27 | 2014-11-17 | ベクトン ディキンソン フランス | 医療用注射装置においてプラズマ処理したシリコーンオイルのコーティングとしての使用 |
JP2015523422A (ja) * | 2012-05-07 | 2015-08-13 | ベクトン ディキンソン フランス | 医療容器用潤滑性コーティング |
WO2016102068A1 (en) * | 2014-12-23 | 2016-06-30 | Merz Pharma Gmbh & Co. Kgaa | Botulinum toxin prefilled container |
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US11628257B2 (en) | 2023-04-18 |
KR102372106B1 (ko) | 2022-03-08 |
US20230218830A1 (en) | 2023-07-13 |
KR20190029637A (ko) | 2019-03-20 |
MX2019000263A (es) | 2019-05-27 |
CN116870298A (zh) | 2023-10-13 |
EP3481467A1 (en) | 2019-05-15 |
CN107596503A (zh) | 2018-01-19 |
JP7042792B2 (ja) | 2022-03-28 |
JP2022046705A (ja) | 2022-03-23 |
WO2018011190A1 (en) | 2018-01-18 |
US20190290856A1 (en) | 2019-09-26 |
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