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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insulin
aqueous solution
less
pharmaceutical composition
concentration
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JP2010525033A5 (enExample
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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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    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions 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)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (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

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US (1) US20100120660A1 (enExample)
EP (2) EP2152243A2 (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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ES2601839T3 (es) 2006-09-22 2017-02-16 Novo Nordisk A/S Análogos de insulina resistentes a proteasas
JP5496082B2 (ja) 2007-04-30 2014-05-21 ノボ・ノルデイスク・エー/エス タンパク質組成物を乾燥させる方法、乾燥タンパク質組成物、及び乾燥タンパク質を含有する薬学的組成物
EP2254905B1 (en) 2008-03-14 2016-12-14 Novo Nordisk A/S Protease-stabilized insulin analogues
DK2254906T3 (en) 2008-03-18 2017-01-23 Novo Nordisk As Protease-stabilized acylated insulin analogues
SG178195A1 (en) * 2009-07-31 2012-03-29 Sanofi Aventis Deutschland Long acting insulin composition
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
EP3459558B1 (en) * 2010-06-25 2020-07-29 Aston University Glycoproteins having lipid mobilizing properties and therapeutic uses thereof
EP2646046A4 (en) * 2010-11-30 2015-03-18 Joslin Diabetes Center Inc COMPOSITIONS AND METHODS FOR TREATING NERVOUS DISORDER IN CONNECTION WITH DIABETES
CN105853348B (zh) 2011-03-10 2019-08-30 Xeris药物公司 肠胃外注射用稳定溶液
ES2574761T3 (es) 2011-10-31 2016-06-21 Xeris Pharmaceuticals, Inc. Formulaciones para el tratamiento de la diabetes
CA2870313A1 (en) 2012-04-11 2013-10-17 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
AU2014333979B2 (en) 2013-10-07 2018-02-15 Novo Nordisk A/S Novel derivative of an insulin analogue
AU2015300944B2 (en) 2014-08-06 2019-07-11 Xeris Pharmaceuticals, Inc. Syringes, kits, and methods for intracutaneous and/or subcutaneous injection of pastes
CA3011902C (en) * 2015-02-25 2023-08-15 Dance Biopharm, 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
CA3020567A1 (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
WO2018222922A1 (en) 2017-06-02 2018-12-06 Xeris Pharmaceuticals, Inc. Precipitation resistant small molecule drug formulations
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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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
JP5496082B2 (ja) * 2007-04-30 2014-05-21 ノボ・ノルデイスク・エー/エス タンパク質組成物を乾燥させる方法、乾燥タンパク質組成物、及び乾燥タンパク質を含有する薬学的組成物

Patent Citations (8)

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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

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

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