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DE69914934D1 - Stabile wässrige insulinzubereitungen ohne phenol und kresol - Google Patents

Stabile wässrige insulinzubereitungen ohne phenol und kresol

Info

Publication number
DE69914934D1
DE69914934D1 DE69914934T DE69914934T DE69914934D1 DE 69914934 D1 DE69914934 D1 DE 69914934D1 DE 69914934 T DE69914934 T DE 69914934T DE 69914934 T DE69914934 T DE 69914934T DE 69914934 D1 DE69914934 D1 DE 69914934D1
Authority
DE
Germany
Prior art keywords
phenol
kresol
stable aqueous
insulin preparations
aqueous insulin
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
DE69914934T
Other languages
English (en)
Other versions
DE69914934T2 (de
Inventor
Svend Havelund
Niels Kaarsholm
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.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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 Novo Nordisk AS filed Critical Novo Nordisk AS
Application granted granted Critical
Publication of DE69914934D1 publication Critical patent/DE69914934D1/de
Publication of DE69914934T2 publication Critical patent/DE69914934T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
DE69914934T 1998-11-18 1999-11-16 Stabile, wässrige insulin-präparate ohne phenol und cresol Expired - Lifetime DE69914934T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DK98015 1998-11-17
DKPA199801506 1998-11-18
PCT/DK1999/000627 WO2000029013A1 (en) 1998-11-18 1999-11-16 Stable aqueous insulin preparations without phenol and cresol

Publications (2)

Publication Number Publication Date
DE69914934D1 true DE69914934D1 (de) 2004-03-25
DE69914934T2 DE69914934T2 (de) 2005-01-05

Family

ID=8105552

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69914934T Expired - Lifetime DE69914934T2 (de) 1998-11-18 1999-11-16 Stabile, wässrige insulin-präparate ohne phenol und cresol

Country Status (6)

Country Link
EP (1) EP1131089B1 (de)
JP (1) JP2002529514A (de)
AT (1) ATE259653T1 (de)
AU (1) AU1263400A (de)
DE (1) DE69914934T2 (de)
WO (1) WO2000029013A1 (de)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10114178A1 (de) 2001-03-23 2002-10-10 Aventis Pharma Gmbh Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität
WO2003027081A2 (en) * 2001-09-14 2003-04-03 Novo Nordisk A/S NOVEL LIGANDS FOR THE HisB10 Zn2+ SITES OF THE R-STATE INSULIN HEXAMER
DE10227232A1 (de) 2002-06-18 2004-01-15 Aventis Pharma Deutschland Gmbh Saure Insulinzubereitungen mit verbesserter Stabilität
JP2006519791A (ja) * 2003-03-13 2006-08-31 ノボ ノルディスク アクティーゼルスカブ 新規なnphインスリン製剤
WO2006014673A2 (en) 2004-07-19 2006-02-09 Nobex Corporation Insulin-oligomer conjugates, formulations and uses thereof
EP2152243A2 (de) * 2007-04-30 2010-02-17 Novo Nordisk A/S Hochkonzentrierte insulinlösungen und zusammensetzungen
KR101234540B1 (ko) 2007-10-16 2013-02-19 바이오콘 리미티드 경구 투여가능한 고형 약제학적 조성물 및 그 제조방법
WO2010028055A1 (en) * 2008-09-02 2010-03-11 Biodel, Inc. Insulin with a basal release profile
HUE068164T2 (hu) 2008-10-17 2024-12-28 Sanofi Aventis Deutschland Egy inzulin és egy GLP-1 agonista kombinációja
CA2780460C (en) 2009-11-13 2018-09-04 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a glp-1 agonist, an insulin and methionine
SG10201500871TA (en) 2009-11-13 2015-04-29 Sanofi Aventis Deutschland Pharmaceutical composition comprising a glp-1 agonist and methionine
US9180261B2 (en) 2010-01-12 2015-11-10 Dance Biopharm Inc. Preservative free insulin formulations and systems and methods for aerosolizing
US10842951B2 (en) 2010-01-12 2020-11-24 Aerami Therapeutics, Inc. Liquid insulin formulations and methods relating thereto
US8637458B2 (en) 2010-05-12 2014-01-28 Biodel Inc. Insulin with a stable basal release profile
RS55378B1 (sr) 2010-08-30 2017-03-31 Sanofi Aventis Deutschland Upotreba ave0010 za proizvodnju leka za tretman diabetes mellitus tipa 2
US9821032B2 (en) 2011-05-13 2017-11-21 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
BR112014004726A2 (pt) 2011-08-29 2017-04-04 Sanofi Aventis Deutschland combinação farmacêutica para uso no controle glicêmico em pacientes de diabetes tipo 2
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
CN104870469A (zh) * 2012-12-26 2015-08-26 沃克哈特有限公司 药物组合物
TWI758239B (zh) 2014-12-12 2022-03-21 德商賽諾菲阿凡提斯德意志有限公司 甘精胰島素/利司那肽固定比率配製劑
CA3011902C (en) * 2015-02-25 2023-08-15 Dance Biopharm, Inc. Liquid insulin formulations and methods relating thereto
TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第2型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第2型糖尿病病患之治療

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4735902A (en) * 1984-10-23 1988-04-05 Matti Siren Stabilized composition containing inositoltriphosphate
US5474978A (en) * 1994-06-16 1995-12-12 Eli Lilly And Company Insulin analog formulations
KR100451778B1 (ko) * 1996-06-20 2004-11-16 노보 노르디스크 에이/에스 Nacl을함유하는인슐린제제

Also Published As

Publication number Publication date
DE69914934T2 (de) 2005-01-05
AU1263400A (en) 2000-06-05
EP1131089B1 (de) 2004-02-18
EP1131089A1 (de) 2001-09-12
JP2002529514A (ja) 2002-09-10
ATE259653T1 (de) 2004-03-15
WO2000029013A1 (en) 2000-05-25

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