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MX2019000263A - Metodo para reducir una cantidad de particulas subvisibles en una composicion farmaceutica. - Google Patents

Metodo para reducir una cantidad de particulas subvisibles en una composicion farmaceutica.

Info

Publication number
MX2019000263A
MX2019000263A MX2019000263A MX2019000263A MX2019000263A MX 2019000263 A MX2019000263 A MX 2019000263A MX 2019000263 A MX2019000263 A MX 2019000263A MX 2019000263 A MX2019000263 A MX 2019000263A MX 2019000263 A MX2019000263 A MX 2019000263A
Authority
MX
Mexico
Prior art keywords
barrel
pharmaceutical composition
reducing
amount
subvisible particles
Prior art date
Application number
MX2019000263A
Other languages
English (en)
Inventor
Bernard Hamel Jean-
Chevolleau Tzvetelina
Fremon Benoit
Jouffray Sèbastien
Original Assignee
Becton Dickinson France
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 Becton Dickinson France filed Critical Becton Dickinson France
Publication of MX2019000263A publication Critical patent/MX2019000263A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/007—After-treatment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/14—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by electrical means
    • B05D3/141—Plasma treatment
    • B05D3/145—After-treatment
    • B05D3/148—After-treatment affecting the surface properties of the coating
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D5/00—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/3131—Syringe barrels specially adapted for improving sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31516—Piston or piston-rod constructions, e.g. connection of piston with piston-rod reducing dead-space in the syringe barrel after delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La invención de interés describe un método para reducir una cantidad de partículas subvisibles en una composición farmacéutica contenida en un dispositivo de inyección médico que comprende un contenedor (1) que incluye un cilindro (10) lubricado con un revestimiento lubricante (2) en contacto con la composición farmacéutica y un tapón (14) en acoplamiento deslizante dentro del cilindro (10), el contenedor comprende una región (130, 121, 123) que se extiende distalmente desde el extremo distal (100) del cilindro que no es accesible al tapón. Durante la formación de dicho recubrimiento lubricante (2) en la pared interior del cilindro, el método además comprende limitar al lubricante de depositarse en dicha región (130, 121, 123) que se extiende distalmente desde el extremo distal (100) del cilindro.
MX2019000263A 2016-07-11 2017-07-11 Metodo para reducir una cantidad de particulas subvisibles en una composicion farmaceutica. MX2019000263A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16305874 2016-07-11
PCT/EP2017/067368 WO2018011190A1 (en) 2016-07-11 2017-07-11 Method for reducing an amount of subvisible particles in a pharmaceutical composition

Publications (1)

Publication Number Publication Date
MX2019000263A true MX2019000263A (es) 2019-05-27

Family

ID=56567544

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019000263A MX2019000263A (es) 2016-07-11 2017-07-11 Metodo para reducir una cantidad de particulas subvisibles en una composicion farmaceutica.

Country Status (8)

Country Link
US (2) US11628257B2 (es)
EP (1) EP3481467B1 (es)
JP (2) JP7042792B2 (es)
KR (1) KR102372106B1 (es)
CN (2) CN116870298A (es)
ES (1) ES3014921T3 (es)
MX (1) MX2019000263A (es)
WO (1) WO2018011190A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
FR3093004B1 (fr) * 2019-02-21 2023-04-07 Dev Techniques Plastiques Procede de preparation d’une seringue
EP4649977A1 (en) * 2024-05-14 2025-11-19 SCHOTT Pharma Schweiz AG Method of making a coated container

Family Cites Families (17)

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US4022206A (en) * 1975-08-01 1977-05-10 Merck & Co., Inc. Vaccine delivery system
US5456940A (en) * 1994-03-28 1995-10-10 Minimed Inc. System for lubricating a syringe barrel
JP2001502568A (ja) * 1996-10-18 2001-02-27 シエーリング アクチエンゲゼルシヤフト ポリエチレンからなる注射器プラグを有する注射器
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
DE10036832C1 (de) 2000-07-28 2001-12-13 Schott Glas Verfahren und Vorrichtung zum Aufbringen einer hitzefixierten Gleitmittelschicht auf die Innenwandung von zylindrischen Behältern für medizinische Zwecke
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
US20110186537A1 (en) 2008-09-22 2011-08-04 Becton, Dickinson And Company Systems, Apparatus and Methods for Coating the Interior of a Container Using a Photolysis and/or Thermal Chemical Vapor Deposition Process
US20110276005A1 (en) * 2008-12-03 2011-11-10 Taisei Kako Co., Ltd. Syringe
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
EP4218862A1 (en) 2011-09-27 2023-08-02 Becton Dickinson France Medical injection device comprising a lubricant coating
EP2847306B1 (en) 2012-05-07 2021-08-04 Becton Dickinson France Lubricant coating for medical container
CN104350134B (zh) * 2012-05-29 2018-03-09 贝克顿迪金森法国公司 润滑剂涂层和包含这样的涂层的医用注射装置
CA2949881A1 (en) * 2014-05-26 2015-12-03 Becton Dickinson France Method for storing an emulsion-adjuvanted vaccine in a lubricated medical injection device
CN107106780B (zh) 2014-12-23 2020-10-16 莫茨制药有限及两合公司 肉毒杆菌毒素预填充式容器

Also Published As

Publication number Publication date
KR102372106B1 (ko) 2022-03-08
US20190290856A1 (en) 2019-09-26
EP3481467B1 (en) 2025-03-05
JP2019521781A (ja) 2019-08-08
JP2022046705A (ja) 2022-03-23
US12370311B2 (en) 2025-07-29
EP3481467A1 (en) 2019-05-15
JP7042792B2 (ja) 2022-03-28
CN107596503A (zh) 2018-01-19
EP3481467C0 (en) 2025-03-05
CN116870298A (zh) 2023-10-13
WO2018011190A1 (en) 2018-01-18
ES3014921T3 (en) 2025-04-28
KR20190029637A (ko) 2019-03-20
US11628257B2 (en) 2023-04-18
US20230218830A1 (en) 2023-07-13

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