DE69508837T2 - Protein enthaltende stabilisierte Formulierung und Dosierungskit - Google Patents

Protein enthaltende stabilisierte Formulierung und Dosierungskit

Info

Publication number
DE69508837T2
DE69508837T2 DE69508837T DE69508837T DE69508837T2 DE 69508837 T2 DE69508837 T2 DE 69508837T2 DE 69508837 T DE69508837 T DE 69508837T DE 69508837 T DE69508837 T DE 69508837T DE 69508837 T2 DE69508837 T2 DE 69508837T2
Authority
DE
Germany
Prior art keywords
containing protein
kit containing
stabilized formulation
dosage kit
dosage
Prior art date
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 - Lifetime
Application number
DE69508837T
Other languages
English (en)
Other versions
DE69508837D1 (de
Inventor
Alain Bayol
Thierry Breul
Patrice Dupin
Philippe Faure
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis France
Original Assignee
Sanofi SA
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 Sanofi SA filed Critical Sanofi SA
Application granted granted Critical
Publication of DE69508837D1 publication Critical patent/DE69508837D1/de
Publication of DE69508837T2 publication Critical patent/DE69508837T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit
DE69508837T 1994-05-04 1995-05-02 Protein enthaltende stabilisierte Formulierung und Dosierungskit Expired - Lifetime DE69508837T2 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9405486A FR2719479B1 (fr) 1994-05-04 1994-05-04 Formulation stable lyophilisée comprenant une protéine: kit de dosage.

Publications (2)

Publication Number Publication Date
DE69508837D1 DE69508837D1 (de) 1999-05-12
DE69508837T2 true DE69508837T2 (de) 1999-11-04

Family

ID=9462880

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69508837T Expired - Lifetime DE69508837T2 (de) 1994-05-04 1995-05-02 Protein enthaltende stabilisierte Formulierung und Dosierungskit

Country Status (25)

Country Link
US (1) US5763409A (de)
EP (1) EP0682944B1 (de)
JP (1) JP2948125B2 (de)
KR (1) KR100273053B1 (de)
CN (1) CN1088583C (de)
AT (1) ATE178484T1 (de)
AU (1) AU694763B2 (de)
CA (1) CA2148537C (de)
CZ (1) CZ286195B6 (de)
DE (1) DE69508837T2 (de)
DK (1) DK0682944T3 (de)
ES (1) ES2131781T3 (de)
FI (1) FI117321B (de)
FR (1) FR2719479B1 (de)
GR (1) GR3030146T3 (de)
HU (1) HU220220B (de)
IL (1) IL113578A (de)
MX (1) MX9502034A (de)
NO (1) NO320364B1 (de)
NZ (1) NZ272045A (de)
PL (1) PL179240B1 (de)
RU (1) RU2136306C1 (de)
SI (1) SI0682944T1 (de)
TW (1) TW397687B (de)
ZA (1) ZA953596B (de)

Families Citing this family (55)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
DE19539574A1 (de) * 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
FR2740686B1 (fr) 1995-11-03 1998-01-16 Sanofi Sa Formulation pharmaceutique lyophilisee stable
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
FR2768341B1 (fr) * 1997-09-18 2000-04-14 Lab Francais Du Fractionnement Composition pharmaceutique placebo lyophilisable destinee a imiter un medicament, notamment a base de proteines ou de polypeptides
EP0913177A1 (de) 1997-11-03 1999-05-06 Roche Diagnostics GmbH Verfahren zur Herstellung trockener, amorpher Produkte enthaltend biologisch aktive Materialien mittels Konvektionstrocknung, insbesondere Sprühtrocknung
EP0913178A1 (de) * 1997-11-03 1999-05-06 Boehringer Mannheim Gmbh Verfahren zur Herstellung trockener, amorpher Produkte enthaltend biologisch aktive Materialen mittels Konvektionstrocknung und die erhaltenen Produkte
EP1071465A1 (de) * 1998-03-18 2001-01-31 Ronai, Peter Amorphe gläser zur stabilisierung von empfindlichen produkten
PT2130554E (pt) * 1999-02-22 2012-11-19 Univ Connecticut Formulações de factor viii isentas de albumina
WO2001030373A1 (fr) * 1999-10-28 2001-05-03 Institut Neftekhimicheskogo Sinteza Imeni A.V.To Pchieva Rossiiskoi Akademii Nauk (Inkhs Ran) Composition polypeptidique
US6653062B1 (en) 2000-07-26 2003-11-25 Wisconsin Alumni Research Foundation Preservation and storage medium for biological materials
WO2002038170A2 (en) * 2000-11-07 2002-05-16 Chiron Corporation Stabilized inteferon compositions
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
US20040247628A1 (en) * 2001-10-24 2004-12-09 Frank-Christophe Lintz Kit for the preparation of a pharmaceutical composition
EP1549434A1 (de) 2002-05-13 2005-07-06 Becton Dickinson and Company Probenahmesystem mit proteasehemmer
US6803046B2 (en) * 2002-08-16 2004-10-12 Bracco International B.V. Sincalide formulations
EP1589949B1 (de) * 2003-01-08 2008-08-13 Novartis Vaccines and Diagnostics, Inc. Stabilisierte lyophilisierte zubereitungen mit gewebefaktor-inhibitor (tfpi) oder varianten des gewebefaktor-inhibitors
GB0304636D0 (en) * 2003-02-28 2003-04-02 Britannia Pharmaceuticals Ltd Pharmaceutical composition for nasal delivery
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
GB0404586D0 (en) * 2004-03-01 2004-04-07 Britannia Pharmaceuticals Ltd Improvements in or relating to organic materials
US11229746B2 (en) 2006-06-22 2022-01-25 Excelsior Medical Corporation Antiseptic cap
RU2541784C2 (ru) 2006-11-07 2015-02-20 Санофи Пастер Байолоджикс Ко. Лиофилизированная композиция для индукции иммунного ответа на флавивирус, композиция и способ для ее получения
AU2008269086B2 (en) * 2007-06-25 2014-06-12 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
GB0715285D0 (en) * 2007-08-06 2007-09-12 Britannia Pharmaceuticals Ltd Improvements in or relating to powdered medicaments for nasal delivery
US9078992B2 (en) 2008-10-27 2015-07-14 Pursuit Vascular, Inc. Medical device for applying antimicrobial to proximal end of catheter
US20100168018A1 (en) 2008-11-07 2010-07-01 Baxter International Inc. Factor viii formulations
CN102301235B (zh) * 2008-11-28 2014-11-19 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
EP2496246B1 (de) * 2009-11-03 2018-06-27 Grifols Therapeutics LLC Zusammensetzung, verfahren und kit für einen alpha-1-proteasehmmer
MX337070B (es) * 2009-12-22 2016-02-11 Celldex Therapeutics Inc Método para preparar un conjugado klh-egfrviii.
RU2448156C1 (ru) * 2011-03-17 2012-04-20 Эспосито Трейдинг Лтд Способ получения лиофилизированной субстанции
RU2448158C1 (ru) * 2011-03-24 2012-04-20 Эспосито Трейдинг Лтд Способ получения препарата фортелизин, обладающего фибринолитическими свойствами, и его применение для лечения инфаркта миокарда
ES2797649T3 (es) 2011-07-12 2020-12-03 Icu Medical Inc Dispositivo para entrega de agente antimicrobiano en un catéter transdérmico
EP2760998B1 (de) * 2011-11-22 2017-02-01 Siemens Healthcare Diagnostics Inc. Vorrichtungen mit vewendung von trockenreagenzien zur rekonstitution als kalibrier- und/oder qualitätskontrolllösungen sowie verfahren zu ihrer herstellung und verwendung
US20140017318A1 (en) * 2012-07-10 2014-01-16 Kevin O'Connell Method to produce a medicinal product comprising a biologically active protein and the resulting product
US9314519B2 (en) 2012-08-21 2016-04-19 Intervet Inc. Liquid stable virus vaccines
US9393298B2 (en) 2013-03-15 2016-07-19 Intervet Inc. Liquid stable bovine virus vaccines
US9480739B2 (en) 2013-03-15 2016-11-01 Intervet Inc. Bovine virus vaccines that are liquid stable
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
TW201605468A (zh) 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
AR099470A1 (es) 2014-02-17 2016-07-27 Intervet Int Bv Vacunas de virus de aves de corral líquidas
TWI670085B (zh) 2014-02-19 2019-09-01 荷蘭商英特威國際公司 液體穩定之豬病毒疫苗
CA2982456A1 (en) 2015-05-08 2016-11-17 Icu Medical, Inc. Medical connectors configured to receive emitters of therapeutic agents
JP2018524067A (ja) 2015-06-11 2018-08-30 アットウィル メディカル ソルーションズ インコーポレイテッド アンチトロンビン−ヘパリン組成物を利用する医療機器、システムおよび方法
AU2017341782B2 (en) 2016-10-14 2023-03-16 Icu Medical, Inc. Sanitizing caps for medical connectors
WO2018204206A2 (en) 2017-05-01 2018-11-08 Icu Medical, Inc. Medical fluid connectors and methods for providing additives in medical fluid lines
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
US11534595B2 (en) 2018-11-07 2022-12-27 Icu Medical, Inc. Device for delivering an antimicrobial composition into an infusion device
US11517732B2 (en) 2018-11-07 2022-12-06 Icu Medical, Inc. Syringe with antimicrobial properties
US11541220B2 (en) 2018-11-07 2023-01-03 Icu Medical, Inc. Needleless connector with antimicrobial properties
US11541221B2 (en) 2018-11-07 2023-01-03 Icu Medical, Inc. Tubing set with antimicrobial properties
US11400195B2 (en) 2018-11-07 2022-08-02 Icu Medical, Inc. Peritoneal dialysis transfer set with antimicrobial properties
CA3118905A1 (en) 2018-11-21 2020-05-28 Icu Medical, Inc. Antimicrobial device comprising a cap with ring and insert
EP4255552A1 (de) 2020-12-07 2023-10-11 ICU Medical, Inc. Peritonealdialysekappen, systeme und verfahren

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5822445B2 (ja) * 1982-07-08 1983-05-09 株式会社 ミドリ十字 安定な固体の人血漿コリンエステラ−ゼ製剤の製法
US5037644A (en) * 1986-10-27 1991-08-06 Cetus Corporation Pharmaceutical compositions of recombinant interleukin-2 and formulation processes
US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
JPH0296536A (ja) * 1988-09-29 1990-04-09 Green Cross Corp:The プラスミノゲン乾燥製剤
ATE111585T1 (de) * 1990-01-18 1994-09-15 Cereria Amos Sgarbi Spa Grablicht.
US5192743A (en) * 1992-01-16 1993-03-09 Genentech, Inc. Reconstitutable lyophilized protein formulation
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
DE4239877C1 (de) * 1992-11-27 1994-03-17 Boehringer Ingelheim Int Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung

Also Published As

Publication number Publication date
IL113578A (en) 1999-10-28
AU1777495A (en) 1995-11-16
KR950031103A (ko) 1995-12-18
EP0682944B1 (de) 1999-04-07
EP0682944A1 (de) 1995-11-22
RU2136306C1 (ru) 1999-09-10
CA2148537A1 (en) 1995-11-05
CN1116522A (zh) 1996-02-14
FI952119A (fi) 1995-11-05
FI952119A0 (fi) 1995-05-03
JP2948125B2 (ja) 1999-09-13
HU9501276D0 (en) 1995-06-28
FR2719479A1 (fr) 1995-11-10
SI0682944T1 (en) 1999-08-31
DK0682944T3 (da) 1999-10-18
NO320364B1 (no) 2005-11-28
CZ286195B6 (cs) 2000-02-16
HUT72325A (en) 1996-04-29
ATE178484T1 (de) 1999-04-15
ZA953596B (en) 1996-11-04
NO951724D0 (no) 1995-05-03
CA2148537C (en) 2002-07-16
PL308416A1 (en) 1995-11-13
TW397687B (en) 2000-07-11
ES2131781T3 (es) 1999-08-01
KR100273053B1 (ko) 2000-12-01
IL113578A0 (en) 1995-08-31
AU694763B2 (en) 1998-07-30
FI117321B (fi) 2006-09-15
US5763409A (en) 1998-06-09
FR2719479B1 (fr) 1996-07-26
MX9502034A (es) 1997-02-28
PL179240B1 (pl) 2000-08-31
HU220220B (hu) 2001-11-28
DE69508837D1 (de) 1999-05-12
CN1088583C (zh) 2002-08-07
JPH0853361A (ja) 1996-02-27
GR3030146T3 (en) 1999-08-31
NZ272045A (en) 1996-02-27
NO951724L (no) 1995-11-06
CZ108195A3 (en) 1996-02-14

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Legal Events

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8327 Change in the person/name/address of the patent owner

Owner name: SANOFI-SYNTHELABO, PARIS, FR

8327 Change in the person/name/address of the patent owner

Owner name: SANOFI-AVENTIS, PARIS, FR

R082 Change of representative

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Representative=s name: TER MEER STEINMEISTER & PARTNER GBR PATENTANWA, DE