DE69928006D1 - Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1 - Google Patents

Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1

Info

Publication number
DE69928006D1
DE69928006D1 DE69928006T DE69928006T DE69928006D1 DE 69928006 D1 DE69928006 D1 DE 69928006D1 DE 69928006 T DE69928006 T DE 69928006T DE 69928006 T DE69928006 T DE 69928006T DE 69928006 D1 DE69928006 D1 DE 69928006D1
Authority
DE
Germany
Prior art keywords
glucagon
liquid compositions
similar peptide
stability liquid
peptide
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
Other languages
English (en)
Other versions
DE69928006T2 (de
Inventor
L Brader
H Pekar
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.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
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 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

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
    • 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
    • A61K38/26—Glucagons
    • 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
    • A61K38/28—Insulins
    • 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
    • A61K47/16—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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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 true DE69928006D1 (de) 2005-12-01
DE69928006T2 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 (de)
JP (1) JP4689833B2 (de)
AT (1) ATE307603T1 (de)
AU (1) AU2373400A (de)
CA (1) CA2358107C (de)
DE (1) DE69928006T2 (de)
DK (1) DK1140148T3 (de)
ES (1) ES2249933T3 (de)
WO (1) WO2000037098A1 (de)

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EP2062593A3 (de) 2000-12-01 2011-08-17 Takeda Pharmaceutical Company Limited Verfahren zur Herstellung einer Zubereitung mit bioaktiven Peptiden
EP1412384B1 (de) * 2001-06-28 2007-12-26 Novo Nordisk A/S Stabile formulierung von modifiziertem glp-1
WO2003020201A2 (en) 2001-08-28 2003-03-13 Eli Lilly And Company Pre-mixes of glp-1 and basal insulin
CN1571676A (zh) 2001-10-19 2005-01-26 伊莱利利公司 Glp－1和胰岛素的双相混合物
CA2841097A1 (en) 2001-12-21 2003-07-24 Human Genome Sciences, Inc. Albumin and g-csf fusion proteins
CN1771080B (zh) 2003-04-08 2010-12-15 诺沃挪第克公司 包括至少一个色谱处理步骤的生产治疗用多肽或其前体的方法
WO2004089985A1 (en) * 2003-04-11 2004-10-21 Novo Nordisk A/S Stable pharmaceutical compositions
JP2007524592A (ja) * 2003-06-03 2007-08-30 ノボ・ノルデイスク・エー／エス 安定化された薬学的ペプチド組成物
KR101308912B1 (ko) * 2003-06-03 2013-09-23 노보 노르디스크 에이/에스 안정화된 약학적 펩티드 조성물
ATE529126T1 (de) * 2003-06-03 2011-11-15 Novo Nordisk As Stabilisierte pharmazeutische peptid zusammensetzungen
PL1633390T3 (pl) * 2003-06-03 2012-06-29 Novo Nordisk As Stabilizowane kompozycje farmaceutyczne peptydu glp-1
EP1687019B1 (de) 2003-11-20 2017-11-22 Novo Nordisk A/S Für die herstellung und verwendung in injektionsvorrichtungen optimale propylenglykol enhaltende peptidformulierungen
US8710181B2 (en) 2004-08-31 2014-04-29 Novo Nordisk A/S Use of tris(hydroxymethyl) aminomethane for the stabilization of peptides, polypeptides and proteins
DE602005016952D1 (de) 2004-10-21 2009-11-12 Novo Nordisk As Wählmechanismus für einen drehstift
ES2575984T3 (es) * 2004-11-12 2016-07-04 Novo Nordisk A/S Formulaciones estables de péptidos que contienen un análogo de GLP-1 acilado y una insulina basal
ES2735533T3 (es) * 2004-11-12 2019-12-19 Novo Nordisk As Formulaciones estables de GLP-1
PL2209800T3 (pl) 2007-11-16 2013-12-31 Novo Nordisk As Stabilne kompozycje farmaceutyczne zawierające liraglutyd i degludec
EP2384338A4 (de) * 2008-12-29 2013-01-16 Panacea Biotec Ltd Glp-1-analoga und anwendungen davon
WO2010138671A1 (en) 2009-05-28 2010-12-02 Amylin Pharmaceuticals, Inc. Glp-1 receptor agonist compounds for sleep enhancement
US20120294855A1 (en) 2009-11-03 2012-11-22 Eli Lilly & Company Glp-1 receptor agonist compounds for obstructive sleep apnea
JP2014504588A (ja) 2010-12-22 2014-02-24 アミリン・ファーマシューティカルズ，リミテッド・ライアビリティ・カンパニー 膵島細胞移植のためのｇｌｐ−１受容体アゴニスト
RU2014128518A (ru) 2011-12-29 2016-02-20 Ново Нордиск А/С Механизм увеличения/уменьшения дозы для взводимого шприца-ручки
US20150359864A1 (en) * 2012-03-09 2015-12-17 Oncotherapy Science, Inc. Pharmaceutical composition containing peptides
EP2873422A4 (de) 2012-07-10 2015-12-30 Takeda Pharmaceutical Pharmazeutische zubereitung zur injektion
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
SG11201503526UA (en) 2012-12-21 2015-06-29 Sanofi Sa 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
WO2015086733A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/glucagon receptor agonists
WO2015086729A1 (en) 2013-12-13 2015-06-18 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
WO2015086730A1 (en) 2013-12-13 2015-06-18 Sanofi Non-acylated exendin-4 peptide analogues
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
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
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
AR105284A1 (es) 2015-07-10 2017-09-20 Sanofi Sa Derivados de exendina-4 como agonistas peptídicos duales específicos de los receptores de glp-1 / glucagón
SG11201805255TA (en) 2015-12-23 2018-07-30 Amgen Inc Method of treating or ameliorating metabolic disorders using binding proteins for gastric inhibitory peptide receptor (gipr) in combination with glp-1 agonists
JOP20190177A1 (ar) 2017-01-17 2019-07-16 Amgen Inc طريقة لعلاج أو تحسين اضطرابات أيضية باستخدام مساعدات مستقبل glp-1 مقترنة بمناهضات لمستقبل ببتيد مثبط معوي (gipr)
PE20200013A1 (es) 2017-06-20 2020-01-06 Amgen Inc Metodo para tratar o mejorar trastornos metabolicos con proteinas de union para el receptor peptidico inhibidor gastrico (gipr) en combinacion con agonistas de glp-1
JP6633777B2 (ja) 2017-08-24 2020-01-22 ノヴォ ノルディスク アー／エス Ｇｌｐ−１組成物及びその使用
WO2020208541A1 (en) * 2019-04-08 2020-10-15 Enzene Biosciences Limited Composition comprising glp-1 analogue
US20220372072A1 (en) * 2019-09-19 2022-11-24 Dr. Reddy's Laboratories Limited Improved purification processes for liraglutide
WO2021142733A1 (en) * 2020-01-16 2021-07-22 Shanghai Benemae Pharmaceutical Corporation Combinational therapy comprising glp-1 and/or glp-1 analogs, and insulin and/or insulin analogs
US11318191B2 (en) 2020-02-18 2022-05-03 Novo Nordisk A/S GLP-1 compositions and uses thereof

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ATE110083T1 (de) * 1986-05-05 1994-09-15 Gen Hospital Corp Insulinotropes hormon.
US5118666A (en) * 1986-05-05 1992-06-02 The General Hospital Corporation Insulinotropic hormone
DK36492D0 (da) * 1992-03-19 1992-03-19 Novo Nordisk As Praeparat
US5705483A (en) * 1993-12-09 1998-01-06 Eli Lilly And Company Glucagon-like insulinotropic peptides, compositions and methods
GB9409496D0 (en) * 1994-05-12 1994-06-29 London Health Ass Method for improving glycaemic control in diabetes
EP0796106B1 (de) * 1994-12-23 2003-03-19 Novo Nordisk A/S Glp-1 zusammensetzungen mit verlängerter wirkdauer

Also Published As

Publication number Publication date
JP4689833B2 (ja) 2011-05-25
CA2358107A1 (en) 2000-06-29
AU2373400A (en) 2000-07-12
CA2358107C (en) 2011-08-23
DK1140148T3 (da) 2006-01-30
EP1140148A1 (de) 2001-10-10
ES2249933T3 (es) 2006-04-01
DE69928006T2 (de) 2006-07-13
ATE307603T1 (de) 2005-11-15
EP1140148B1 (de) 2005-10-26
WO2000037098A1 (en) 2000-06-29
JP2002532557A (ja) 2002-10-02

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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