ATE307603T1 - Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1 - Google Patents
Lagerstabile flüssige zusammensetzungen von glucagon-ähnlichem peptid-1Info
- Publication number
- ATE307603T1 ATE307603T1 AT99967463T AT99967463T ATE307603T1 AT E307603 T1 ATE307603 T1 AT E307603T1 AT 99967463 T AT99967463 T AT 99967463T AT 99967463 T AT99967463 T AT 99967463T AT E307603 T1 ATE307603 T1 AT E307603T1
- Authority
- AT
- Austria
- Prior art keywords
- glucagon
- peptide
- liquid compositions
- stable liquid
- storage stable
- Prior art date
Links
- DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 Chemical group 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
- 239000000203 mixture Substances 0.000 title abstract 2
- 239000007788 liquid Substances 0.000 title 1
- 206010012601 diabetes mellitus Diseases 0.000 abstract 1
- 238000009472 formulation Methods 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11349998P | 1998-12-22 | 1998-12-22 | |
| PCT/US1999/030395 WO2000037098A1 (en) | 1998-12-22 | 1999-12-21 | Shelf-stable formulation of glucagon-like peptide-1 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ATE307603T1 true ATE307603T1 (de) | 2005-11-15 |
Family
ID=22349808
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT99967463T ATE307603T1 (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) |
Families Citing this family (50)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
| JP2003530838A (ja) | 2000-04-12 | 2003-10-21 | ヒューマン ゲノム サイエンシズ インコーポレイテッド | アルブミン融合タンパク質 |
| US6663602B2 (en) | 2000-06-16 | 2003-12-16 | Novo Nordisk A/S | Injection device |
| ATE416784T1 (de) | 2000-12-01 | 2008-12-15 | Takeda Pharmaceutical | Verfahren zur herstellung einer zubereitung mit einer bioaktiven substanz |
| 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 |
| JP2005508360A (ja) | 2001-10-19 | 2005-03-31 | イーライ・リリー・アンド・カンパニー | Ｇｌｐ−１およびインスリンの二相混合物 |
| ES2425738T3 (es) | 2001-12-21 | 2013-10-17 | Human Genome Sciences, Inc. | Proteínas de fusión de la albúmina |
| EP1594530A4 (de) | 2003-01-22 | 2006-10-11 | Human Genome Sciences Inc | Albuminfusionsproteine |
| 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 |
| BRPI0410972C1 (pt) | 2003-06-03 | 2021-05-25 | Novo Nordisk As | método para aumentar a vida de armazenagem de uma composição farmacêutica, composição farmacêutica, e, método para tratamento de hiperglicemia |
| PL1633390T3 (pl) * | 2003-06-03 | 2012-06-29 | Novo Nordisk As | Stabilizowane kompozycje farmaceutyczne peptydu glp-1 |
| EP1633391B1 (de) * | 2003-06-03 | 2011-10-19 | Novo Nordisk A/S | Stabilisierte pharmazeutische peptid zusammensetzungen |
| CN1812808B (zh) * | 2003-06-03 | 2012-07-04 | 诺沃挪第克公司 | 稳定化的药物肽组合物 |
| 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 |
| DK1804865T3 (da) | 2004-10-21 | 2010-02-01 | Novo Nordisk As | Neddrejeindstillingsmekanisme til en pen med fjederoptræk |
| 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 |
| CN106137952B (zh) * | 2004-11-12 | 2020-11-17 | 诺和诺德公司 | 促胰岛素肽的稳定制剂 |
| ES2612736T3 (es) | 2007-11-16 | 2017-05-18 | Novo Nordisk A/S | Composiciones farmacéuticas estables que comprenden liraglutida y degludec |
| US20110269680A1 (en) * | 2008-12-29 | 2011-11-03 | Panacea Biotec Limited | Glp-1 analogs and uses thereof |
| EP2435061A4 (de) | 2009-05-28 | 2013-03-27 | Amylin Pharmaceuticals Inc | Schlaffördernde glp-1-rezeptor-agonistenverbindungen |
| US20120294855A1 (en) | 2009-11-03 | 2012-11-22 | Eli Lilly & Company | Glp-1 receptor agonist compounds for obstructive sleep apnea |
| WO2012088157A2 (en) | 2010-12-22 | 2012-06-28 | Amylin Pharmaceuticals, Inc. | Glp-1 receptor agonists for islet cell transplantation |
| RU2014128518A (ru) | 2011-12-29 | 2016-02-20 | Ново Нордиск А/С | Механизм увеличения/уменьшения дозы для взводимого шприца-ручки |
| WO2013133405A1 (ja) * | 2012-03-09 | 2013-09-12 | オンコセラピー・サイエンス株式会社 | ペプチドを含む医薬組成物 |
| WO2014010586A1 (ja) | 2012-07-10 | 2014-01-16 | 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 |
| SG10201705097PA (en) | 2012-12-21 | 2017-07-28 | Sanofi Sa | Functionalized exendin-4 derivatives |
| 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 |
| WO2015086730A1 (en) | 2013-12-13 | 2015-06-18 | Sanofi | Non-acylated exendin-4 peptide analogues |
| EP3080149A1 (de) | 2013-12-13 | 2016-10-19 | Sanofi | Duale glp-1-/glucagon-rezeptoragonisten |
| TW201609795A (zh) | 2013-12-13 | 2016-03-16 | 賽諾菲公司 | 作為雙重ｇｌｐ－１／ｇｉｐ受體促效劑的艾塞那肽－４（ｅｘｅｎｄｉｎ－４）胜肽類似物 |
| WO2015086729A1 (en) | 2013-12-13 | 2015-06-18 | Sanofi | 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 |
| 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) |
| AU2018288854B2 (en) | 2017-06-20 | 2025-06-26 | Amgen Inc. | Method of treating or ameliorating metabolic disorders using binding proteins for gastric inhibitory peptide receptor (GIPR) in combination with GLP-1 agonists |
| CA3263567A1 (en) | 2017-06-21 | 2025-10-30 | 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 |
| TWI847306B (zh) | 2017-08-24 | 2024-07-01 | 丹麥商諾佛 儂迪克股份有限公司 | Ｇｌｐ-１組成物及其用途 |
| WO2020208541A1 (en) * | 2019-04-08 | 2020-10-15 | Enzene Biosciences Limited | Composition comprising glp-1 analogue |
| WO2021053578A1 (en) * | 2019-09-19 | 2021-03-25 | 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 |
| BR112022013795A2 (pt) | 2020-02-18 | 2022-09-13 | Novo Nordisk As | Composição farmacêutica líquida, e, kit |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| AU4298596A (en) * | 1994-12-23 | 1996-07-19 | Novo Nordisk A/S | Protracted glp-1 compositions |
-
1999
- 1999-12-21 CA CA2358107A patent/CA2358107C/en not_active Expired - Fee Related
- 1999-12-21 JP JP2000589208A patent/JP4689833B2/ja not_active Expired - Fee Related
- 1999-12-21 DE DE69928006T patent/DE69928006T2/de not_active Expired - Lifetime
- 1999-12-21 WO PCT/US1999/030395 patent/WO2000037098A1/en not_active Ceased
- 1999-12-21 EP EP99967463A patent/EP1140148B1/de not_active Expired - Lifetime
- 1999-12-21 AT AT99967463T patent/ATE307603T1/de active
- 1999-12-21 AU AU23734/00A patent/AU2373400A/en not_active Abandoned
- 1999-12-21 DK DK99967463T patent/DK1140148T3/da active
- 1999-12-21 ES ES99967463T patent/ES2249933T3/es not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| DK1140148T3 (da) | 2006-01-30 |
| CA2358107C (en) | 2011-08-23 |
| DE69928006D1 (de) | 2005-12-01 |
| WO2000037098A1 (en) | 2000-06-29 |
| JP2002532557A (ja) | 2002-10-02 |
| EP1140148A1 (de) | 2001-10-10 |
| ES2249933T3 (es) | 2006-04-01 |
| DE69928006T2 (de) | 2006-07-13 |
| JP4689833B2 (ja) | 2011-05-25 |
| AU2373400A (en) | 2000-07-12 |
| EP1140148B1 (de) | 2005-10-26 |
| CA2358107A1 (en) | 2000-06-29 |
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