JP2010525033A - 高濃縮のインスリン溶液及び組成物 - Google Patents

高濃縮のインスリン溶液及び組成物 Download PDF

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Publication number
JP2010525033A
JP2010525033A JP2010504743A JP2010504743A JP2010525033A JP 2010525033 A JP2010525033 A JP 2010525033A JP 2010504743 A JP2010504743 A JP 2010504743A JP 2010504743 A JP2010504743 A JP 2010504743A JP 2010525033 A JP2010525033 A JP 2010525033A
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Prior art keywords
insulin
aqueous solution
less
pharmaceutical composition
concentration
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JP2010525033A5 (enExample
Inventor
ペル バルシュミット,
ペル−オルフ ワールンド,
スヴェンド ハヴェルンド,
シモン, ビエレガード イェンセン,
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ノボ・ノルデイスク・エー/エス
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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2010504743A 2007-04-30 2008-04-30 高濃縮のインスリン溶液及び組成物 Withdrawn JP2010525033A (ja)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP07107221 2007-04-30
EP07109906 2007-06-08
EP07117798 2007-10-03
PCT/EP2008/055341 WO2008132229A2 (en) 2007-04-30 2008-04-30 Highly concentrated insulin solutions and compositions

Publications (2)

Publication Number Publication Date
JP2010525033A true JP2010525033A (ja) 2010-07-22
JP2010525033A5 JP2010525033A5 (enExample) 2014-09-18

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JP2010504743A Withdrawn JP2010525033A (ja) 2007-04-30 2008-04-30 高濃縮のインスリン溶液及び組成物

Country Status (4)

Country Link
US (1) US20100120660A1 (enExample)
EP (2) EP2514412A1 (enExample)
JP (1) JP2010525033A (enExample)
WO (1) WO2008132229A2 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020502145A (ja) * 2016-12-16 2020-01-23 ノヴォ ノルディスク アー/エス インスリン含有医薬組成物

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CN101541830A (zh) 2006-09-22 2009-09-23 诺沃-诺迪斯克有限公司 蛋白酶抗性的胰岛素类似物
WO2008132224A2 (en) 2007-04-30 2008-11-06 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein
CN101970477B (zh) * 2008-03-14 2014-12-31 诺沃-诺迪斯克有限公司 蛋白酶稳定的胰岛素类似物
HUE032284T2 (en) 2008-03-18 2017-09-28 Novo Nordisk As Protease-stabilized, acylated insulin analogues
DK2459171T3 (en) * 2009-07-31 2017-09-25 Sanofi Aventis Deutschland Long-acting insulin composition
US10842951B2 (en) 2010-01-12 2020-11-24 Aerami Therapeutics, Inc. Liquid insulin formulations and methods relating thereto
US9180261B2 (en) 2010-01-12 2015-11-10 Dance Biopharm Inc. Preservative free insulin formulations and systems and methods for aerosolizing
CN103068400A (zh) * 2010-06-25 2013-04-24 阿斯顿大学 具有脂类动员性质的糖蛋白及其治疗用途
US20140194353A1 (en) * 2010-11-30 2014-07-10 Joslin Diabetes Center, Inc. Compositions and methods for the treatment of nervous disorders associated with diabetes
WO2012122535A2 (en) * 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
JP6117811B2 (ja) * 2011-10-31 2017-04-19 ゼリス ファーマシューティカルズ インコーポレイテッド 糖尿病を処置するための製剤
EP2836508B1 (en) 2012-04-11 2016-06-29 Novo Nordisk A/S Insulin formulations
US9125805B2 (en) 2012-06-27 2015-09-08 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of small molecule drugs
US20140179597A1 (en) * 2012-11-16 2014-06-26 Steven Lehrer Method for the treatment and prevention of Alzheimer's disease and central nervous system dysfunction
US9018162B2 (en) 2013-02-06 2015-04-28 Xeris Pharmaceuticals, Inc. Methods for rapidly treating severe hypoglycemia
CA2926701A1 (en) 2013-10-07 2015-04-16 Novo Nordisk A/S Novel derivative of an insulin analogue
KR102428675B1 (ko) 2014-08-06 2022-08-02 엑스에리스 파머수티클스, 인크. 페이스트의 피내 및/또는 피하 주사를 위한 주사기, 키트, 및 방법
EP3261648B1 (en) 2015-02-25 2023-12-06 Aerami Therapeutics, Inc. Liquid insulin formulations and methods relating thereto
US9649364B2 (en) 2015-09-25 2017-05-16 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic formulations in aprotic polar solvents
US11590205B2 (en) 2015-09-25 2023-02-28 Xeris Pharmaceuticals, Inc. Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
WO2017180708A1 (en) * 2016-04-12 2017-10-19 Cell and Molecular Tissue Engineering, LLC Systems, methods and products for minimizing tissue reactions and tissue injury at an infusion site
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
CN117085022A (zh) 2017-06-02 2023-11-21 Xeris药物公司 抗沉淀的小分子药物制剂
US11478534B1 (en) * 2021-07-13 2022-10-25 America Great Health Formulation and method of preparing zinc-charged insulin for oral administration
US20230025595A1 (en) * 2021-07-13 2023-01-26 America Great Health, a California Corporation Formulation and Method of Preparing Divalent Cation Charged Insulin for Oral Administration

Citations (8)

* Cited by examiner, † Cited by third party
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JPH01502434A (ja) * 1987-02-25 1989-08-24 ノボ ノルディスク アクティーゼルスカブ 新規インシュリン誘導体
JP2001199899A (ja) * 1994-06-16 2001-07-24 Eli Lilly & Co インスリン類似化合物複合体
JP2001522815A (ja) * 1997-11-12 2001-11-20 アルザ コーポレイション ポリペプチド類の自己会合を減少させる方法
JP2002527487A (ja) * 1998-10-16 2002-08-27 ノボ ノルディスク アクティーゼルスカブ 肺送達のための安定に濃縮されたインスリン製剤
JP2002529514A (ja) * 1998-11-18 2002-09-10 ノボ ノルディスク アクティーゼルスカブ フェノール及びクレゾールを要さない安定なインスリン水性調製物
JP2004523589A (ja) * 2001-03-23 2004-08-05 アベンティス・ファーマ・ドイチユラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 改善された安定性を有するいかなる量の亜鉛も含有しないかまたはほんの少量の亜鉛しか含有しないインスリン製剤
JP2005532365A (ja) * 2002-06-18 2005-10-27 アベンティス・ファーマ・ドイチユラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 改善された安定性を有する酸性インスリン調製物
WO2007047948A2 (en) * 2005-10-20 2007-04-26 Nastech Pharmaceutical Company Inc. Intranasal administration of rapid acting insulin

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PH23446A (en) * 1986-10-20 1989-08-07 Novo Industri As Peptide preparations
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US6489292B1 (en) * 1998-11-18 2002-12-03 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
JP3799924B2 (ja) 2000-01-11 2006-07-19 株式会社日立製作所 電力用遮断器および発電所電気回路装置
WO2008132224A2 (en) * 2007-04-30 2008-11-06 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01502434A (ja) * 1987-02-25 1989-08-24 ノボ ノルディスク アクティーゼルスカブ 新規インシュリン誘導体
JP2001199899A (ja) * 1994-06-16 2001-07-24 Eli Lilly & Co インスリン類似化合物複合体
JP2001522815A (ja) * 1997-11-12 2001-11-20 アルザ コーポレイション ポリペプチド類の自己会合を減少させる方法
JP2002527487A (ja) * 1998-10-16 2002-08-27 ノボ ノルディスク アクティーゼルスカブ 肺送達のための安定に濃縮されたインスリン製剤
JP2002529514A (ja) * 1998-11-18 2002-09-10 ノボ ノルディスク アクティーゼルスカブ フェノール及びクレゾールを要さない安定なインスリン水性調製物
JP2004523589A (ja) * 2001-03-23 2004-08-05 アベンティス・ファーマ・ドイチユラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 改善された安定性を有するいかなる量の亜鉛も含有しないかまたはほんの少量の亜鉛しか含有しないインスリン製剤
JP2005532365A (ja) * 2002-06-18 2005-10-27 アベンティス・ファーマ・ドイチユラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 改善された安定性を有する酸性インスリン調製物
WO2007047948A2 (en) * 2005-10-20 2007-04-26 Nastech Pharmaceutical Company Inc. Intranasal administration of rapid acting insulin

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020502145A (ja) * 2016-12-16 2020-01-23 ノヴォ ノルディスク アー/エス インスリン含有医薬組成物
JP2020105227A (ja) * 2016-12-16 2020-07-09 ノヴォ ノルディスク アー/エス インスリン含有医薬組成物

Also Published As

Publication number Publication date
EP2152243A2 (en) 2010-02-17
WO2008132229A2 (en) 2008-11-06
US20100120660A1 (en) 2010-05-13
EP2514412A1 (en) 2012-10-24
WO2008132229A3 (en) 2009-03-12

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