KR101084412B1 - 코팅된 제약 용기 내 안정화된 액상 단백질 제제 - Google Patents

코팅된 제약 용기 내 안정화된 액상 단백질 제제 Download PDF

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Publication number
KR101084412B1
KR101084412B1 KR20057021160A KR20057021160A KR101084412B1 KR 101084412 B1 KR101084412 B1 KR 101084412B1 KR 20057021160 A KR20057021160 A KR 20057021160A KR 20057021160 A KR20057021160 A KR 20057021160A KR 101084412 B1 KR101084412 B1 KR 101084412B1
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KR
South Korea
Prior art keywords
container
pharmaceutical composition
formulation
comp
closure means
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Legal status (The legal status 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 status listed.)
Expired - Fee Related
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KR20057021160A
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English (en)
Korean (ko)
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KR20060009913A (ko
Inventor
파브리지오 사마리타니
알레산드라 델 리오
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아레스 트레이딩 에스.에이.
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Application filed by 아레스 트레이딩 에스.에이. filed Critical 아레스 트레이딩 에스.에이.
Publication of KR20060009913A publication Critical patent/KR20060009913A/ko
Application granted granted Critical
Publication of KR101084412B1 publication Critical patent/KR101084412B1/ko
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Classifications

    • 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
    • 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

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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (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)
KR20057021160A 2003-05-13 2004-05-12 코팅된 제약 용기 내 안정화된 액상 단백질 제제 Expired - Fee Related KR101084412B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP03010671.0 2003-05-13
EP03010671 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
KR20060009913A KR20060009913A (ko) 2006-02-01
KR101084412B1 true KR101084412B1 (ko) 2011-11-21

Family

ID=33442722

Family Applications (1)

Application Number Title Priority Date Filing Date
KR20057021160A Expired - Fee Related KR101084412B1 (ko) 2003-05-13 2004-05-12 코팅된 제약 용기 내 안정화된 액상 단백질 제제

Country Status (22)

Country Link
US (2) USRE43331E1 (https=)
EP (2) EP1633388B1 (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) NO20055774L (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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JP4988562B2 (ja) * 2004-06-01 2012-08-01 アレス トレーディング ソシエテ アノニム 安定化したインターフェロン液体製剤
AU2006204937B2 (en) * 2005-01-12 2011-02-10 Biogen Ma Inc. Method for delivering Interferon-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
JP5563475B2 (ja) * 2007-12-20 2014-07-30 メルク セローノ ソシエテ アノニム Ｐｅｇインターフェロン−ベータ製剤
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
BR112012013093A2 (pt) 2009-12-21 2017-12-12 Genentech Inc ''formulação farmacêutica aquosa estável, artigo, métodos para estabilizar um anticorpo, para tratamento de uma doença ou distúrbio em um indivíduo, para reduzir a agregação de um anticorpo monoclonal terapêutico e de fabricação de uma formulação farmaceutica, frasco e tanque de aço inoxidável
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
WO2013176754A1 (en) 2012-05-24 2013-11-28 Abbvie Inc. Novel purification of antibodies using hydrophobic interaction chromatography
EP4414376A3 (en) 2012-12-03 2024-11-06 Novobiotic Pharmaceuticals, LLC Novel depsipeptide and uses thereof
BR112015017307A2 (pt) 2013-03-14 2017-11-21 Abbvie Inc composições de espécies com baixa acidez e métodos para produção e uso das mesmas
CA2899449A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. Low acidic species compositions and methods for producing the same using displacement chromatography
ES2837626T3 (es) 2013-07-10 2021-07-01 Matrix Biology Inst Composiciones de hialuronano con alta elasticidad y usos de las mismas
WO2015050959A1 (en) 2013-10-01 2015-04-09 Yale University Anti-kit antibodies and methods of use thereof
BR112016010475B1 (pt) * 2014-03-13 2021-07-20 Stevanato Group International A.S. Método de manuseio de uma formulação farmacêutica líquida
WO2016004197A1 (en) 2014-07-03 2016-01-07 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
ES2871199T3 (es) 2015-09-24 2021-10-28 Matrix Biology Inst Composiciones de hialuronano de alta elasticidad y métodos de uso de las mismas
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
CN110612306B (zh) 2017-04-04 2024-05-07 诺沃生物医药有限责任公司 新缩肽类及其用途
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
JP2024500994A (ja) 2020-12-28 2024-01-10 デボル，インコーポレイテッド タンパク質及び多官能化変性ポリエチレングリコール系架橋剤を含む反応性乾燥粉末状止血用材料

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Also Published As

Publication number Publication date
EP1633388B1 (en) 2014-03-19
AU2004237982C1 (en) 2018-03-08
PL1633388T3 (pl) 2014-08-29
IL171912A (en) 2015-02-26
BRPI0410679A (pt) 2006-06-20
NO20055774D0 (no) 2005-12-06
EP2324845A1 (en) 2011-05-25
AU2004237982A1 (en) 2004-11-25
JP2012096063A (ja) 2012-05-24
MXPA05012191A (es) 2006-02-08
USRE43331E1 (en) 2012-05-01
JP2007502684A (ja) 2007-02-15
NO20055774L (no) 2005-12-06
US7540382B2 (en) 2009-06-02
PT1633388E (pt) 2014-06-25
AU2004237982B2 (en) 2010-03-04
WO2004100979A3 (en) 2005-05-19
HK1088558A1 (zh) 2006-11-10
CN1809376B (zh) 2010-04-28
ES2471942T3 (es) 2014-06-27
WO2004100979A2 (en) 2004-11-25
EA008308B1 (ru) 2007-04-27
IL171912A0 (en) 2006-04-10
CY1115233T1 (el) 2017-01-04
KR20060009913A (ko) 2006-02-01
HRP20140267T1 (hr) 2014-04-25
EA200501692A1 (ru) 2006-06-30
AR044302A1 (es) 2005-09-07
EP1633388A2 (en) 2006-03-15
SI1633388T1 (sl) 2014-05-30
CN1809376A (zh) 2006-07-26
CA2523477A1 (en) 2004-11-25
US20070092487A1 (en) 2007-04-26
DK1633388T3 (da) 2014-04-07
UA91493C2 (uk) 2010-08-10

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