CN1809376B - 装在药物容器中的稳定的液体蛋白质制剂 - Google Patents

装在药物容器中的稳定的液体蛋白质制剂 Download PDF

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Publication number
CN1809376B
CN1809376B CN2004800169917A CN200480016991A CN1809376B CN 1809376 B CN1809376 B CN 1809376B CN 2004800169917 A CN2004800169917 A CN 2004800169917A CN 200480016991 A CN200480016991 A CN 200480016991A CN 1809376 B CN1809376 B CN 1809376B
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CN
China
Prior art keywords
container
interferon
protein
formulation
sealing device
Prior art date
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Expired - Lifetime
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CN2004800169917A
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English (en)
Chinese (zh)
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CN1809376A (zh
Inventor
F·萨马利塔尼
A·德尔里奥
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Ares Trading SA
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Ares Trading SA
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Publication of CN1809376A publication Critical patent/CN1809376A/zh
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/215—IFN-beta
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/005—Closures provided with linings or internal coatings so as to avoid contact of the closure with the contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Food Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
CN2004800169917A 2003-05-13 2004-05-12 装在药物容器中的稳定的液体蛋白质制剂 Expired - Lifetime CN1809376B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP03010671 2003-05-13
EP03010671.0 2003-05-13
PCT/EP2004/050779 WO2004100979A2 (en) 2003-05-13 2004-05-12 Liquid stabilized protein formulations in coated pharmaceutical containers

Publications (2)

Publication Number Publication Date
CN1809376A CN1809376A (zh) 2006-07-26
CN1809376B true CN1809376B (zh) 2010-04-28

Family

ID=33442722

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2004800169917A Expired - Lifetime CN1809376B (zh) 2003-05-13 2004-05-12 装在药物容器中的稳定的液体蛋白质制剂

Country Status (22)

Country Link
US (2) US7540382B2 (https=)
EP (2) EP2324845A1 (https=)
JP (2) JP2007502684A (https=)
KR (1) KR101084412B1 (https=)
CN (1) CN1809376B (https=)
AR (1) AR044302A1 (https=)
AU (1) AU2004237982C1 (https=)
BR (1) BRPI0410679A (https=)
CA (1) CA2523477A1 (https=)
CY (1) CY1115233T1 (https=)
DK (1) DK1633388T3 (https=)
EA (1) EA008308B1 (https=)
ES (1) ES2471942T3 (https=)
HR (1) HRP20140267T1 (https=)
IL (1) IL171912A (https=)
MX (1) MXPA05012191A (https=)
NO (1) NO20055774D0 (https=)
PL (1) PL1633388T3 (https=)
PT (1) PT1633388E (https=)
SI (1) SI1633388T1 (https=)
UA (1) UA91493C2 (https=)
WO (1) WO2004100979A2 (https=)

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JP2007538048A (ja) * 2004-05-17 2007-12-27 アレス トレーディング ソシエテ アノニム ヒドロゲル・インターフェロン製剤
UA92146C2 (ru) * 2004-06-01 2010-10-11 Эйрэс Трейдинг С.А. Стабилизированная жидкая композиция, которая содержит интерферон
PT1845925T (pt) * 2005-01-12 2016-11-22 Biogen Ma Inc Método para distribuir interferão-beta
WO2007016562A2 (en) * 2005-07-29 2007-02-08 Amgen Inc. Formulations that inhibit protein aggregation
WO2007127668A2 (en) * 2006-04-26 2007-11-08 Wyeth Novel processes for coating container means which inhibit precipitation of polysaccharide-protein conjugate formulations
KR100785070B1 (ko) 2006-07-11 2007-12-12 삼성전자주식회사 휴대 단말기에서 디지털 저작권 관리 콘텐츠 재생 방법 및장치
EP2170268A2 (en) 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
BRPI0821029A2 (pt) * 2007-12-20 2015-06-16 Merck Serono Sa Fomulações de peg-interferon-beta
JP5933975B2 (ja) 2008-11-12 2016-06-15 メディミューン，エルエルシー 抗体製剤
JP6214161B2 (ja) 2009-12-21 2017-10-18 ジェネンテック， インコーポレイテッド 抗体製剤
US8802603B2 (en) 2010-06-17 2014-08-12 Becton, Dickinson And Company Medical components having coated surfaces exhibiting low friction and low reactivity
WO2012022734A2 (en) 2010-08-16 2012-02-23 Medimmune Limited Anti-icam-1 antibodies and methods of use
FR2966044B1 (fr) * 2010-10-18 2012-11-02 Sanofi Pasteur Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
TW202244057A (zh) 2012-12-03 2022-11-16 美商諾維生物製藥有限公司 新穎縮肽及其用途
CA2926301A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. Low acidic species compositions and methods for producing and using the same
WO2014159554A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. Low acidic species compositions and methods for producing the same using displacement chromatography
EP4137139A1 (en) 2013-07-10 2023-02-22 Matrix Biology Institute Compositions of hyaluronan with high elasticity and uses thereof
WO2015050959A1 (en) 2013-10-01 2015-04-09 Yale University Anti-kit antibodies and methods of use thereof
EP3041803B1 (en) * 2014-03-13 2019-11-27 Stevanato Group International A. S. Method of handling a liquid drug formulation
US20170226552A1 (en) 2014-07-03 2017-08-10 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using cobalt
WO2016007764A1 (en) 2014-07-09 2016-01-14 Abbvie Inc. Methods for modulating the glycosylation profile of recombinant proteins using non-commonly used sugars
WO2016144773A1 (en) 2015-03-06 2016-09-15 Abbvie Inc. Arabinosylated glycoproteins
WO2016163764A2 (ko) * 2015-04-07 2016-10-13 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제
PL3352766T3 (pl) 2015-09-24 2021-08-02 Matrix Biology Institute Kompozycie z hialuronanem o dużej elastyczności i sposoby ich użycia
WO2017147003A1 (en) 2016-02-26 2017-08-31 Novobiotic Pharmaceuticals, Llc Novel macrocyclic antibiotics and uses thereof
FI126979B (en) 2016-02-29 2017-09-15 Faron Pharmaceuticals Oy Lyophilized pharmaceutical formulation and its use
EP3606941B1 (en) 2017-04-04 2024-05-01 Novobiotic Pharmaceuticals, LLC Novel depsipeptides and uses thereof
US12161777B2 (en) 2020-07-02 2024-12-10 Davol Inc. Flowable hemostatic suspension
US11739166B2 (en) 2020-07-02 2023-08-29 Davol Inc. Reactive polysaccharide-based hemostatic agent
EP4267210A1 (en) 2020-12-28 2023-11-01 Davol Inc. Reactive dry powdered hemostatic materials comprising a protein and a multifunctionalized modified polyethylene glycol based crosslinking agent

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EP0641567A1 (en) * 1993-08-13 1995-03-08 Ciba-Geigy Ag Stable pharmaceutical compositions containing hybrid alpha-interferon
EP0736303A2 (en) * 1995-04-06 1996-10-09 F. Hoffmann-La Roche Ag Interferon solution
WO1997017087A1 (en) * 1995-11-07 1997-05-15 Genentech, Inc. Stabilizing formulation for ngf
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
WO1998028007A1 (en) * 1996-12-24 1998-07-02 Biogen, Inc. Stable liquid interferon formulations
CN2326243Y (zh) * 1997-09-29 1999-06-30 程继勇 覆膜药用瓶塞
CN2441750Y (zh) * 2000-06-23 2001-08-08 程继勇 表面覆膜药用橡胶瓶塞
CN1341542A (zh) * 2001-10-18 2002-03-27 郑秀娣 药品瓶塞隔离膜

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US2622598A (en) 1951-03-08 1952-12-23 Premo Pharmaceutical Lab Inc Drain-clear container for aqueous liquid pharmaceutical preparations
US5183746A (en) 1986-10-27 1993-02-02 Schering Aktiengesellschaft Formulation processes for pharmaceutical compositions of recombinant β-
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US6142977A (en) 1996-10-18 2000-11-07 Schering Ag Prefilled, sterilized syringe with a new and improved plug
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JP2002209975A (ja) * 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓

Patent Citations (8)

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Publication number Priority date Publication date Assignee Title
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
EP0641567A1 (en) * 1993-08-13 1995-03-08 Ciba-Geigy Ag Stable pharmaceutical compositions containing hybrid alpha-interferon
EP0736303A2 (en) * 1995-04-06 1996-10-09 F. Hoffmann-La Roche Ag Interferon solution
WO1997017087A1 (en) * 1995-11-07 1997-05-15 Genentech, Inc. Stabilizing formulation for ngf
WO1998028007A1 (en) * 1996-12-24 1998-07-02 Biogen, Inc. Stable liquid interferon formulations
CN2326243Y (zh) * 1997-09-29 1999-06-30 程继勇 覆膜药用瓶塞
CN2441750Y (zh) * 2000-06-23 2001-08-08 程继勇 表面覆膜药用橡胶瓶塞
CN1341542A (zh) * 2001-10-18 2002-03-27 郑秀娣 药品瓶塞隔离膜

Also Published As

Publication number Publication date
PT1633388E (pt) 2014-06-25
IL171912A (en) 2015-02-26
US7540382B2 (en) 2009-06-02
MXPA05012191A (es) 2006-02-08
KR101084412B1 (ko) 2011-11-21
PL1633388T3 (pl) 2014-08-29
EP1633388A2 (en) 2006-03-15
DK1633388T3 (da) 2014-04-07
HK1088558A1 (zh) 2006-11-10
WO2004100979A2 (en) 2004-11-25
CY1115233T1 (el) 2017-01-04
AU2004237982A1 (en) 2004-11-25
CN1809376A (zh) 2006-07-26
SI1633388T1 (sl) 2014-05-30
USRE43331E1 (en) 2012-05-01
BRPI0410679A (pt) 2006-06-20
EP2324845A1 (en) 2011-05-25
EA008308B1 (ru) 2007-04-27
IL171912A0 (en) 2006-04-10
WO2004100979A3 (en) 2005-05-19
AU2004237982C1 (en) 2018-03-08
ES2471942T3 (es) 2014-06-27
EA200501692A1 (ru) 2006-06-30
NO20055774L (no) 2005-12-06
CA2523477A1 (en) 2004-11-25
UA91493C2 (uk) 2010-08-10
JP2012096063A (ja) 2012-05-24
AR044302A1 (es) 2005-09-07
HRP20140267T1 (hr) 2014-04-25
KR20060009913A (ko) 2006-02-01
NO20055774D0 (no) 2005-12-06
AU2004237982B2 (en) 2010-03-04
JP2007502684A (ja) 2007-02-15
EP1633388B1 (en) 2014-03-19
US20070092487A1 (en) 2007-04-26

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IP01 Partial invalidation of patent right

Commission number: 4W111649

Conclusion of examination: On the basis of claims 1-14 submitted by the patentee on February 20, 2021, the validity of invention patent right No. 200480016991.7 is maintained

Decision date of declaring invalidation: 20210506

Decision number of declaring invalidation: 49682

Denomination of invention: Stable liquid protein preparations loaded in drug containers

Granted publication date: 20100428

Patentee: ARES TRADING S.A.

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Granted publication date: 20100428

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