DE69837159D1 - Verfahren zur herstellung einer einzeldosisspritze mit lyophilisierter proteinmischung zur verabreichung eines volumens von weniger als 0,5 ml - Google Patents

Verfahren zur herstellung einer einzeldosisspritze mit lyophilisierter proteinmischung zur verabreichung eines volumens von weniger als 0,5 ml

Info

Publication number
DE69837159D1
DE69837159D1 DE69837159T DE69837159T DE69837159D1 DE 69837159 D1 DE69837159 D1 DE 69837159D1 DE 69837159 T DE69837159 T DE 69837159T DE 69837159 T DE69837159 T DE 69837159T DE 69837159 D1 DE69837159 D1 DE 69837159D1
Authority
DE
Germany
Prior art keywords
less
volume
administration
preparing
single dose
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
DE69837159T
Other languages
English (en)
Other versions
DE69837159T2 (de
Inventor
Karin Limrell
Ebba Florin-Robertsson
Elvy Hoekby
Ulf Nilsson
Anders Stroem
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.)
Pfizer Health AB
Original Assignee
Pfizer Health AB
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 Pfizer Health AB filed Critical Pfizer Health AB
Publication of DE69837159D1 publication Critical patent/DE69837159D1/de
Application granted granted Critical
Publication of DE69837159T2 publication Critical patent/DE69837159T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • 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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DE69837159T 1997-11-28 1998-11-19 Verfahren zur herstellung einer einzeldosisspritze mit lyophilisierter proteinmischung zur verabreichung eines volumens von weniger als 0,5 ml Expired - Lifetime DE69837159T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9704405 1997-11-28
SE9704405A SE9704405D0 (sv) 1997-11-28 1997-11-28 New syringe
PCT/SE1998/002096 WO1999027983A1 (en) 1997-11-28 1998-11-19 A ONE DOSE SYRINGE, COMPRISING A FREEZE-DRIED PROTEIN COMPOSITION, FOR ADMINISTERING OF A VOLUME LESS THAN 0.5 ml

Publications (2)

Publication Number Publication Date
DE69837159D1 true DE69837159D1 (de) 2007-04-05
DE69837159T2 DE69837159T2 (de) 2007-11-22

Family

ID=20409182

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69837159T Expired - Lifetime DE69837159T2 (de) 1997-11-28 1998-11-19 Verfahren zur herstellung einer einzeldosisspritze mit lyophilisierter proteinmischung zur verabreichung eines volumens von weniger als 0,5 ml

Country Status (24)

Country Link
US (1) US6152897A (de)
EP (1) EP1034007B1 (de)
JP (1) JP4564652B2 (de)
KR (1) KR100567358B1 (de)
CN (1) CN1156315C (de)
AT (1) ATE354390T1 (de)
AU (1) AU742494B2 (de)
CA (1) CA2311754C (de)
CY (1) CY1106403T1 (de)
CZ (1) CZ300255B6 (de)
DE (1) DE69837159T2 (de)
DK (1) DK1034007T3 (de)
ES (1) ES2281142T3 (de)
HK (1) HK1032920A1 (de)
HU (1) HUP0004410A3 (de)
MX (1) MXPA00005214A (de)
NO (1) NO324692B1 (de)
NZ (1) NZ505150A (de)
PL (1) PL193243B1 (de)
PT (1) PT1034007E (de)
RU (1) RU2214285C2 (de)
SE (1) SE9704405D0 (de)
SK (1) SK285668B6 (de)
WO (1) WO1999027983A1 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7959600B2 (en) 2004-12-30 2011-06-14 Byeong S. Chang Container closure delivery system
US20060157507A1 (en) * 2004-12-30 2006-07-20 Chang Byeong S Multi-functional container closure delivery system
US20060144869A1 (en) * 2004-12-30 2006-07-06 Chang Byeong S Container closure delivery system
US8062254B2 (en) * 2008-01-08 2011-11-22 MacLean, LLC Spring driven adjustable oral syringe
CN103582473B (zh) 2011-01-10 2016-11-02 拜昂·塞翁·常 紧凑药物复原装置和方法
GB2498774A (en) 2012-01-27 2013-07-31 Bruce Roser Glass-stabilised biological materials and syringe
CA2925416A1 (en) 2013-09-27 2015-04-02 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation
MX2017003095A (es) 2014-09-09 2018-01-26 Seon Chang Byeong Dispositivo y método de entrega de solución.
CN109996805B (zh) * 2016-11-29 2023-03-28 丝芭博株式会社 蛋白质组合物、其制造方法和热稳定性提高方法
CN108498467B (zh) * 2018-05-21 2019-03-05 中山未名海济生物医药有限公司 注射用重组人生长激素无菌粉末及其制备方法
IL272145A (en) * 2020-01-20 2021-07-29 Stem Cell Medicine Ltd Cosmetic preparations with protein concentrate from a conditioned growth medium of stem cells from adipose tissue

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL86799A (en) * 1987-07-02 1993-03-15 Kabi Pharmacia Ab Method and device for injection
US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
JP3108077B2 (ja) * 1989-06-08 2000-11-13 住友製薬株式会社 製剤投与器
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5158546A (en) * 1991-08-07 1992-10-27 Habley Medical Technology Corp. Controlled action self-mixing vial
US5281198A (en) * 1992-05-04 1994-01-25 Habley Medical Technology Corporation Pharmaceutical component-mixing delivery assembly
SE9202108D0 (sv) * 1992-07-07 1992-07-07 Kabi Pharmacia Ab Dual-chamber injection cartridge
AU686567C (en) * 1992-07-31 2002-08-08 Genentech Inc. Human growth hormone aqueous formulation
US5334162A (en) * 1993-03-15 1994-08-02 Eli Lilly And Company Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
FR2752733B1 (fr) * 1996-09-05 1998-11-06 Inst Nat Sante Rech Med Dispositif permeable a base d'hydrogel contenant des cellules vivantes, et ses applications

Also Published As

Publication number Publication date
NO20002754L (no) 2000-05-29
SK7202000A3 (en) 2001-05-10
MXPA00005214A (es) 2002-04-24
PL340731A1 (en) 2001-02-26
ES2281142T3 (es) 2007-09-16
SE9704405D0 (sv) 1997-11-28
CA2311754A1 (en) 1999-06-10
NO20002754D0 (no) 2000-05-29
CA2311754C (en) 2007-12-18
JP2001524360A (ja) 2001-12-04
SK285668B6 (sk) 2007-06-07
EP1034007B1 (de) 2007-02-21
CZ20001948A3 (cs) 2001-04-11
DE69837159T2 (de) 2007-11-22
WO1999027983A1 (en) 1999-06-10
CN1280511A (zh) 2001-01-17
AU742494B2 (en) 2002-01-03
JP4564652B2 (ja) 2010-10-20
EP1034007A1 (de) 2000-09-13
CZ300255B6 (cs) 2009-04-01
CN1156315C (zh) 2004-07-07
KR20010032514A (ko) 2001-04-25
ATE354390T1 (de) 2007-03-15
AU1356699A (en) 1999-06-16
HUP0004410A2 (hu) 2001-04-28
PT1034007E (pt) 2007-04-30
HK1032920A1 (en) 2001-08-10
US6152897A (en) 2000-11-28
PL193243B1 (pl) 2007-01-31
KR100567358B1 (ko) 2006-04-04
NO324692B1 (no) 2007-12-03
RU2214285C2 (ru) 2003-10-20
DK1034007T3 (da) 2007-05-21
CY1106403T1 (el) 2011-10-12
NZ505150A (en) 2002-08-28
HUP0004410A3 (en) 2003-05-28

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