DK1140148T3 - Lagerholdbar formulering af glucagon-agtigt peptid-1 - Google Patents

Lagerholdbar formulering af glucagon-agtigt peptid-1

Info

Publication number: DK1140148T3
Authority: DK; Denmark
Prior art keywords: glucagon; peptide; stable storage; storage formulation; glp
Prior art date: 1998-12-22

Application number

DK99967463T

Other languages

English (en)

Inventor

Mark L Brader

Allen H Pekar

Original Assignee

Lilly Co Eli

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.)

1998-12-22

Filing date

1999-12-21

Publication date

2006-01-30

1999-12-21 Application filed by Lilly Co Eli filed Critical Lilly Co Eli

2006-01-30 Application granted granted Critical

2006-01-30 Publication of DK1140148T3 publication Critical patent/DK1140148T3/da

Links

DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DTHNMHAUYICORS-KTKZVXAJSA-N 0.000 title abstract 2
101800000224 Glucagon-like peptide 1 Proteins 0.000 title abstract 2
102100040918 Pro-glucagon Human genes 0.000 title abstract 2
238000009472 formulation Methods 0.000 title abstract 2
239000000203 mixture Substances 0.000 title abstract 2
206010012601 diabetes mellitus Diseases 0.000 abstract 1
GCYXWQUSHADNBF-AAEALURTSA-N preproglucagon 78-108 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 GCYXWQUSHADNBF-AAEALURTSA-N 0.000 abstract 1
239000003755 preservative agent Substances 0.000 abstract 1
230000002335 preservative effect Effects 0.000 abstract 1
239000008181 tonicity modifier Substances 0.000 abstract 1

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

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)

DK99967463T 1998-12-22 1999-12-21 Lagerholdbar formulering af glucagon-agtigt peptid-1 DK1140148T3 (da)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
US11349998P	1998-12-22	1998-12-22

Publications (1)

Publication Number	Publication Date
DK1140148T3 true DK1140148T3 (da)	2006-01-30

Family

ID=22349808

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DK99967463T DK1140148T3 (da)	1998-12-22	1999-12-21	Lagerholdbar formulering af glucagon-agtigt peptid-1

Country Status (9)

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

Families Citing this family (50)

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AU2002316811A1 (en)	2001-06-28	2003-03-03	Novo Nordisk A/S	Stable formulation of modified glp-1
CA2452044A1 (en)	2001-08-28	2003-03-13	Eli Lilly And Company	Pre-mixes of glp-1 and basal insulin
WO2003035099A1 (en)	2001-10-19	2003-05-01	Eli Lilly And Company	Biphasic mixtures of glp-1 and insulin
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BRPI0408978B8 (pt)	2003-04-08	2021-07-27	Novo Nordisk As	processos para regenerar uma fase estacionária cromatográfica
WO2004089985A1 (en)	2003-04-11	2004-10-21	Novo Nordisk A/S	Stable pharmaceutical compositions
EP1633391B1 (en)	2003-06-03	2011-10-19	Novo Nordisk A/S	Stabilized pharmaceutical peptide compositions
CA2527743A1 (en) *	2003-06-03	2004-12-09	Novo Nordisk A/S	Stabilized pharmaceutical peptide compositions
ATE541582T1 (de) *	2003-06-03	2012-02-15	Novo Nordisk As	Stabilisierte pharmazeutische glp-1 peptid zusammensetzungen
EP2292253A3 (en) *	2003-06-03	2011-12-14	Novo Nordisk A/S	Stabilized pharmaceutical peptide compositions
TR201906789T4 (tr) *	2003-11-20	2019-05-21	Novo Nordisk As	Üretim ve enjeksiyon cihazlarında kullanım için en uygun olan propilen glikol ihtiva eden peptit formülasyonları.
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
US7686786B2 (en)	2004-10-21	2010-03-30	Novo Nordiks A/S	Dial-down mechanism for wind-up pen
RU2413530C9 (ru) *	2004-11-12	2021-05-18	Ново Нордиск А/С	Стабильные препараты инсулинотропных пептидов
WO2006051103A2 (en) *	2004-11-12	2006-05-18	Novo Nordisk A/S	Stable formulations of peptides
JP5241849B2 (ja)	2007-11-16	2013-07-17	ノボ・ノルデイスク・エー／エス	インスリン及びインスリン分泌性ペプチドを含む薬学的組成物
AU2009334289A1 (en) *	2008-12-29	2011-07-28	Panacea Biotec Ltd	GLP-1 analogs and uses thereof
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
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
CN103998077B (zh)	2011-12-29	2017-05-31	诺沃—诺迪斯克有限公司	具有向上拨动/向下拨动定量机构的基于扭力弹簧的卷紧自动注射器笔
SG11201405578TA (en) *	2012-03-09	2014-11-27	Oncotherapy Science Inc	Pharmaceutical composition containing peptide
EP2873422A4 (en)	2012-07-10	2015-12-30	Takeda Pharmaceutical	PHARMACEUTICAL PREPARATION FOR INJECTION
UA116217C2 (uk)	2012-10-09	2018-02-26	Санофі	Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
HK1211232A1 (en)	2012-12-21	2016-05-20	Sanofi	Exendin-4 derivatives as 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
EP3080152A1 (en)	2013-12-13	2016-10-19	Sanofi	Non-acylated exendin-4 peptide analogues
TW201609799A (zh)	2013-12-13	2016-03-16	賽諾菲公司	雙重ｇｌｐ－１／ｇｉｐ受體促效劑
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
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
KR102844773B1 (ko)	2015-12-23	2025-08-13	암젠 인크	위 억제 펩티드 수용체 (gipr)에 대한 결합 단백질을 glp-1 효능제와 조합하여 사용하여 대사 장애를 치료하거나 개선시키는 방법
BR112019014588A2 (pt)	2017-01-17	2020-02-18	Amgen Inc.	Método de tratamento ou amenização de distúrbios metabólicos usando agonistas do receptor de glp-1 conjugados a antagonistas para receptor do peptídeo inibidor gástrico (gipr)
CN110831969B (zh)	2017-06-20	2024-06-21	安进公司	使用抑胃肽受体（gipr）结合蛋白与glp-1激动剂的组合治疗或改善代谢障碍的方法
MX2019015544A (es)	2017-06-21	2020-07-28	Amgen Inc	Metodo para tratar o mejorar trastornos metabolicos con proteinas de fusion de agonistas del receptor de glp-1/proteinas de union antagonistas para el receptor peptidico inhibidor gastrico (gipr).
HRP20240485T1 (hr)	2017-08-24	2024-07-05	Novo Nordisk A/S	Pripravci glp-1 i njihova upotreba
WO2020208541A1 (en) *	2019-04-08	2020-10-15	Enzene Biosciences Limited	Composition comprising glp-1 analogue
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PE20230819A1 (es)	2020-02-18	2023-05-19	Novo Nordisk As	Composiciones y usos de glp-1

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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 (en) *	1994-12-23	2003-03-19	Novo Nordisk A/S	Protracted glp-1 compositions

1999
- 1999-12-21 AU AU23734/00A patent/AU2373400A/en not_active Abandoned
- 1999-12-21 ES ES99967463T patent/ES2249933T3/es not_active Expired - Lifetime
- 1999-12-21 DK DK99967463T patent/DK1140148T3/da active
- 1999-12-21 AT AT99967463T patent/ATE307603T1/de active
- 1999-12-21 DE DE69928006T patent/DE69928006T2/de not_active Expired - Lifetime
- 1999-12-21 JP JP2000589208A patent/JP4689833B2/ja not_active Expired - Fee Related
- 1999-12-21 EP EP99967463A patent/EP1140148B1/en not_active Expired - Lifetime
- 1999-12-21 CA CA2358107A patent/CA2358107C/en not_active Expired - Fee Related
- 1999-12-21 WO PCT/US1999/030395 patent/WO2000037098A1/en not_active Ceased

Also Published As

Publication number	Publication date
JP2002532557A (ja)	2002-10-02
ATE307603T1 (de)	2005-11-15
CA2358107C (en)	2011-08-23
DE69928006D1 (de)	2005-12-01
JP4689833B2 (ja)	2011-05-25
CA2358107A1 (en)	2000-06-29
EP1140148B1 (en)	2005-10-26
ES2249933T3 (es)	2006-04-01
WO2000037098A1 (en)	2000-06-29
AU2373400A (en)	2000-07-12
DE69928006T2 (de)	2006-07-13
EP1140148A1 (en)	2001-10-10

Publication	Publication Date	Title
DK1140148T3 (da)	2006-01-30	Lagerholdbar formulering af glucagon-agtigt peptid-1
EA200300026A1 (ru)	2003-04-24	Аналоги глюкагоноподобного пептида-1
BG103800A (en)	2000-03-31	Method and composition for the treatment of apnoea
FI955315L (fi)	1995-11-06	HIV:n proteaasin inhibiittoreita, jotka ovat käyttökelpoisia AIDS'n hoitoon
CA2260943A1 (en)	1998-02-19	Formulation of 5-ht agonists
DE69434588D1 (de)	2006-02-02	Verzögerte Freigabe von Insulinotropin (GLP-1)
ZA977783B (en)	1999-03-01	Method of inhibiting fibrosis with a somatostatin agonist
AU1718400A (en)	2000-06-05	Method for treating pain
MXPA04001525A (es)	2004-05-31	Analogos de peptido -1 similar al glucagon.
TW200626613A (en)	2006-08-01	Analogues of GLP-1
MXPA03003870A (es)	2004-08-12	Terapia de combinacion que comprende agentes antidiabeticos y anticonvulsionantes.
AU6323001A (en)	2001-12-03	Treatment of acute coronary syndrome with glp-1
RU97118224A (ru)	1999-07-27	Соединения и композиции для доставки активных агентов
MY129356A (en)	2007-03-30	Electrospun pharmaceutical compositions
LU91138I2 (fr)	2005-04-04	Glulisine d'insuline et ses dérivés pharmaceutiquement acceptables.
NO971889D0 (no)	1997-04-24	Forbindelser og sammensetninger for levering av aktive midler
DK0949907T3 (da)	2003-07-14	Fremgangsmåder og præparater til forbedret biotilgængelighed og biologisk aktive midler til slimhindeadministration
EE03422B1 (et)	2001-06-15	Kompositsioonid IRDS ja ARDS raviks
TR200202323T2 (tr)	2002-12-23	Akut akciğer harabiyeti ve fibrozitinin alfavß6 antagonistleriyle tedavisi
IS5504A (is)	2000-05-19	Samsetning virk við meðhöndlun á getuleysi
DK0901790T3 (da)	2001-08-06	Anvendelse af moxonidin til behandling af neuropatisk smerte
BG104059A (en)	2000-10-31	Diabetes treatment with rosiglytazone and insulin
DK0941108T3 (da)	2002-11-18	Sårheling og behandling af fibrose
ES2133152T3 (es)	1999-09-01	Composicion de tiotepa liofilizada estable.
BG104062A (en)	2000-11-30	Treatment of diabetes with thiazolidindion, stimulant of insulin secretion and alpha-glucosidase inhibitor