DE69928006T2 - Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1 - Google Patents

Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1 Download PDF

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Publication number
DE69928006T2
DE69928006T2 DE69928006T DE69928006T DE69928006T2 DE 69928006 T2 DE69928006 T2 DE 69928006T2 DE 69928006 T DE69928006 T DE 69928006T DE 69928006 T DE69928006 T DE 69928006T DE 69928006 T2 DE69928006 T2 DE 69928006T2
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DE
Germany
Prior art keywords
glp
gly
glu
serine
ala
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
DE69928006T
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German (de)
English (en)
Other versions
DE69928006D1 (de
Inventor
L. Mark BRADER
H. Allen PEKAR
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Eli Lilly and Co
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Eli Lilly and Co
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Filing date
Publication date
Application filed by Eli Lilly and Co filed Critical Eli Lilly and Co
Publication of DE69928006D1 publication Critical patent/DE69928006D1/de
Application granted granted Critical
Publication of DE69928006T2 publication Critical patent/DE69928006T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DE69928006T 1998-12-22 1999-12-21 Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1 Expired - Lifetime DE69928006T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11349998P 1998-12-22 1998-12-22
US113499P 1998-12-22
PCT/US1999/030395 WO2000037098A1 (en) 1998-12-22 1999-12-21 Shelf-stable formulation of glucagon-like peptide-1

Publications (2)

Publication Number Publication Date
DE69928006D1 DE69928006D1 (de) 2005-12-01
DE69928006T2 true DE69928006T2 (de) 2006-07-13

Family

ID=22349808

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69928006T Expired - Lifetime DE69928006T2 (de) 1998-12-22 1999-12-21 Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1

Country Status (9)

Country Link
EP (1) EP1140148B1 (https=)
JP (1) JP4689833B2 (https=)
AT (1) ATE307603T1 (https=)
AU (1) AU2373400A (https=)
CA (1) CA2358107C (https=)
DE (1) DE69928006T2 (https=)
DK (1) DK1140148T3 (https=)
ES (1) ES2249933T3 (https=)
WO (1) WO2000037098A1 (https=)

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FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
EP2213743A1 (en) 2000-04-12 2010-08-04 Human Genome Sciences, Inc. Albumin fusion proteins
US6663602B2 (en) 2000-06-16 2003-12-16 Novo Nordisk A/S Injection device
CA2430934C (en) 2000-12-01 2011-06-21 Takeda Chemical Industries, Ltd. A method of producing sustained-release preparations of a bioactive substance using high-pressure gas
WO2003002136A2 (en) 2001-06-28 2003-01-09 Novo Nordisk A/S Stable formulation of modified glp-1
EP1432430A4 (en) 2001-08-28 2006-05-10 Lilly Co Eli PREMIXTURES OF GLP-1 AND BASALINSULIN
MXPA04003569A (es) 2001-10-19 2004-07-23 Lilly Co Eli Mezclas bifasicas de glp-1 e insulina.
WO2005003296A2 (en) 2003-01-22 2005-01-13 Human Genome Sciences, Inc. Albumin fusion proteins
AU2002364586A1 (en) 2001-12-21 2003-07-30 Delta Biotechnology Limited Albumin fusion proteins
KR101198346B1 (ko) 2003-04-08 2012-11-06 노보 노르디스크 에이/에스 크로마토그래피 고정상의 재생
WO2004089985A1 (en) * 2003-04-11 2004-10-21 Novo Nordisk A/S Stable pharmaceutical compositions
ES2375056T3 (es) * 2003-06-03 2012-02-24 Novo Nordisk A/S Composiciones pept�?dicas farmacéuticas estabilizadas.
EP1633390B1 (en) * 2003-06-03 2012-01-18 Novo Nordisk A/S Stabilized pharmaceutical glp-1 peptide compositions
PL1633391T3 (pl) * 2003-06-03 2012-03-30 Novo Nordisk As Stabilizowane farmaceutycznie kompozycje peptydowe
KR101308912B1 (ko) * 2003-06-03 2013-09-23 노보 노르디스크 에이/에스 안정화된 약학적 펩티드 조성물
DK3300721T4 (da) * 2003-11-20 2025-03-03 Novo Nordisk As Propylenglycol-holdige peptidformuleringer hvilke er optimale til fremstilling og til anvendelse i injektionsindretninger
PL1789434T3 (pl) 2004-08-31 2014-07-31 Novo Nordisk As Zastosowanie tris(hydroksymetylo)aminometanu do stabilizacji peptydów, polipeptydów i białek
EP1804865B1 (en) 2004-10-21 2009-09-30 Novo Nordisk A/S Dial-down mechanism for wind-up pen
WO2006051103A2 (en) * 2004-11-12 2006-05-18 Novo Nordisk A/S Stable formulations of peptides
MX2007005521A (es) * 2004-11-12 2007-05-18 Novo Nordisk As Formulaciones estables de peptidos insulinotropicos.
BRPI0820535B8 (pt) 2007-11-16 2021-05-25 Novo Nordisk As composições farmacêuticas contendo insulina e um peptídeo insulinotrópico
BRPI0923853A2 (pt) * 2008-12-29 2016-01-12 Panacea Biotec Ltd análogos de gpl-1 e usos dos mesmos.
EP2435061A4 (en) 2009-05-28 2013-03-27 Amylin Pharmaceuticals Inc DAMPING GLP-1 RECEPTOR AGONIST COMPOUNDS
EP2496249B1 (en) 2009-11-03 2016-03-09 Amylin Pharmaceuticals, LLC Glp-1 receptor agonist for use in treating obstructive sleep apnea
US9161953B2 (en) 2010-12-22 2015-10-20 Amylin Pharmaceuticals, Llc GLP-1 receptor agonists for islet cell transplantation
CA2861706A1 (en) 2011-12-29 2013-07-04 Novo Nordisk A/S Dial-up/dial-down mechanism for wind-up pen
US20150359864A1 (en) * 2012-03-09 2015-12-17 Oncotherapy Science, Inc. Pharmaceutical composition containing peptides
JP6224586B2 (ja) 2012-07-10 2017-11-01 武田薬品工業株式会社 注射用製剤
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
AU2013366692B2 (en) 2012-12-21 2017-11-23 Sanofi Dual GLP1/GIP or trigonal GLP1/GIP/Glucagon agonists
CN103405753B (zh) * 2013-08-13 2016-05-11 上海仁会生物制药股份有限公司 稳定的促胰岛素分泌肽水针药物组合物
EP3080152A1 (en) 2013-12-13 2016-10-19 Sanofi Non-acylated exendin-4 peptide analogues
WO2015086733A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/glucagon receptor agonists
EP3080154B1 (en) 2013-12-13 2018-02-07 Sanofi Dual glp-1/gip receptor agonists
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自exendin-4之雙重glp-1/升糖素受體促效劑
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重glp-1/昇糖素受體激動劑之艾塞那肽-4衍生物
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽-4(Exendin-4)之肽類雙重GLP-1/升糖素受體促效劑
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
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EA201992502A1 (ru) 2017-06-20 2020-04-22 Эмджен Инк. Способ лечения или уменьшения интенсивности метаболических нарушений с применением белков, связывающих рецептор гастроингибиторного пептида (gipr), в комбинации с агонистами glp-1
EP3642238A1 (en) 2017-06-21 2020-04-29 Amgen Inc. Method of treating or ameliorating metabolic disorders using antagonistic binding proteins for gastric inhibitory peptide receptor (gipr)/glp-1 receptor agonist fusion proteins
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ATE234625T1 (de) * 1994-12-23 2003-04-15 Novo Nordisk As Glp-1 zusammensetzungen mit verlängerter wirkdauer

Also Published As

Publication number Publication date
JP4689833B2 (ja) 2011-05-25
JP2002532557A (ja) 2002-10-02
DE69928006D1 (de) 2005-12-01
EP1140148A1 (en) 2001-10-10
EP1140148B1 (en) 2005-10-26
ATE307603T1 (de) 2005-11-15
AU2373400A (en) 2000-07-12
CA2358107A1 (en) 2000-06-29
DK1140148T3 (da) 2006-01-30
WO2000037098A1 (en) 2000-06-29
ES2249933T3 (es) 2006-04-01
CA2358107C (en) 2011-08-23

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Legal Events

Date Code Title Description
8364 No opposition during term of opposition
8328 Change in the person/name/address of the agent

Representative=s name: KROHER, STROBEL RECHTS- UND PATENTANWAELTE, 80336

8328 Change in the person/name/address of the agent

Representative=s name: DR. SCHOEN & PARTNER, 80336 MUENCHEN