ATE277630T1 - Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung - Google Patents

Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung

Info

Publication number
ATE277630T1
ATE277630T1 AT01126054T AT01126054T ATE277630T1 AT E277630 T1 ATE277630 T1 AT E277630T1 AT 01126054 T AT01126054 T AT 01126054T AT 01126054 T AT01126054 T AT 01126054T AT E277630 T1 ATE277630 T1 AT E277630T1
Authority
AT
Austria
Prior art keywords
pulmonary administration
insulin preparations
stable concentrated
concentrated insulin
formulations
Prior art date
Application number
AT01126054T
Other languages
English (en)
Inventor
Svend Havelund
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 ATE277630T1 publication Critical patent/ATE277630T1/de

Links

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
    • A61K38/28—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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays 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
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
AT01126054T 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung ATE277630T1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DKPA199801327 1998-10-16

Publications (1)

Publication Number Publication Date
ATE277630T1 true ATE277630T1 (de) 2004-10-15

Family

ID=8103620

Family Applications (2)

Application Number Title Priority Date Filing Date
AT99948725T ATE218364T1 (de) 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung
AT01126054T ATE277630T1 (de) 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung

Family Applications Before (1)

Application Number Title Priority Date Filing Date
AT99948725T ATE218364T1 (de) 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung

Country Status (22)

Country Link
EP (2) EP1172114B1 (de)
JP (1) JP4212240B2 (de)
KR (1) KR100617286B1 (de)
CN (1) CN1210058C (de)
AT (2) ATE218364T1 (de)
AU (1) AU758146B2 (de)
BR (1) BR9914585A (de)
CA (1) CA2346969A1 (de)
CZ (1) CZ20011134A3 (de)
DE (2) DE69920767T2 (de)
DK (2) DK1121144T3 (de)
ES (2) ES2177323T3 (de)
HU (1) HUP0104111A3 (de)
IL (2) IL142011A0 (de)
NO (1) NO323365B1 (de)
PL (1) PL197504B1 (de)
PT (2) PT1172114E (de)
RU (1) RU2218935C2 (de)
TW (1) TWI223597B (de)
UA (1) UA65636C2 (de)
WO (1) WO2000023098A1 (de)
ZA (1) ZA200102105B (de)

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US5783556A (en) * 1996-08-13 1998-07-21 Genentech, Inc. Formulated insulin-containing composition
DE10114178A1 (de) 2001-03-23 2002-10-10 Aventis Pharma Gmbh Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität
NZ519403A (en) * 2001-06-21 2005-03-24 Pfizer Prod Inc Use of insulin in a medicament to reduce weight gain in a diabetic patient who is using exogenous insulin to control blood sugar levels
WO2003094956A1 (en) 2002-05-07 2003-11-20 Novo Nordisk A/S Soluble formulations comprising monomeric insulin and acylated insulin
DE10227232A1 (de) 2002-06-18 2004-01-15 Aventis Pharma Deutschland Gmbh Saure Insulinzubereitungen mit verbesserter Stabilität
CA2517310C (en) * 2003-02-28 2015-11-24 Chugai Seiyaku Kabushiki Kaisha Stabilized protein-containing formulations comprising a poloxamer
JP2007523842A (ja) * 2003-03-11 2007-08-23 ノボ ノルディスク アクティーゼルスカブ 酸安定化されたインスリンを含有する薬学的製剤
EP2107069B1 (de) 2003-08-05 2013-01-16 Novo Nordisk A/S Neuartige Insulinderivate
US20090074882A1 (en) 2005-12-28 2009-03-19 Novo Nordisk A/S Insulin compositions and method of making a composition
JP5550338B2 (ja) 2006-07-31 2014-07-16 ノボ・ノルデイスク・エー/エス ペグ化持続型インスリン
HUE029512T2 (en) 2006-09-22 2017-03-28 Novo Nordisk As Protease Resistant Insulin Analogs
EP2152243A2 (de) * 2007-04-30 2010-02-17 Novo Nordisk A/S Hochkonzentrierte insulinlösungen und zusammensetzungen
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
JP5552046B2 (ja) * 2007-06-13 2014-07-16 ノボ・ノルデイスク・エー/エス インスリン誘導体を含有する薬学的製剤
JP5762001B2 (ja) 2008-03-14 2015-08-12 ノボ・ノルデイスク・エー/エス プロテアーゼ安定化インスリンアナログ
WO2009115469A1 (en) 2008-03-18 2009-09-24 Novo Nordisk A/S Protease stabilized, acylated insulin analogues
AU2011235959C1 (en) * 2008-06-13 2013-10-10 Eli Lilly And Company PEGylated insulin lispro compounds
TWI451876B (zh) * 2008-06-13 2014-09-11 Lilly Co Eli 聚乙二醇化之離脯胰島素化合物
PT3228320T (pt) 2008-10-17 2020-03-26 Sanofi Aventis Deutschland Combinação de uma insulina e de um agonista do glp-1
KR20110085985A (ko) 2008-10-30 2011-07-27 노보 노르디스크 에이/에스 하루 한번 주사 빈도보다 적은 인슐린 주사를 사용한 진성 당뇨병의 치료
KR101853606B1 (ko) 2009-07-06 2018-05-03 사노피-아벤티스 도이칠란트 게엠베하 메티오닌을 함유하는 수성 인슐린 제제
DK2498802T3 (en) 2009-11-13 2015-04-13 Sanofi Aventis Deutschland Pharmaceutical composition comprising a GLP-1 agonist, insulin and a methionine
KR101337322B1 (ko) 2009-11-13 2013-12-06 사노피-아벤티스 도이칠란트 게엠베하 Glp-1 효능제 및 메티오닌을 포함하는 약제학적 조성물
ES2606554T3 (es) 2010-08-30 2017-03-24 Sanofi-Aventis Deutschland Gmbh Uso de AVE0010 para la fabricación de un medicamento para el tratamiento de la diabetes mellitus de tipo 2
BR112013010345A2 (pt) 2010-10-27 2017-07-25 Novo Nordisk As tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção
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
PL2750699T3 (pl) 2011-08-29 2015-12-31 Sanofi Aventis Deutschland Kombinacja farmaceutyczna do stosowania w kontroli glikemii u pacjentów z cukrzycą typu 2
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
CA2870313A1 (en) 2012-04-11 2013-10-17 Novo Nordisk A/S Insulin formulations
BR112015013223A2 (pt) * 2012-12-26 2017-07-11 Wockhardt Ltd composição farmacêutica
MX369511B (es) 2013-04-03 2019-11-11 Sanofi Sa Tratamiento de la diabetes mellitus mediante formulaciones de insulinas de acción prolongada.
JP2016519127A (ja) 2013-04-30 2016-06-30 ノヴォ ノルディスク アー/エス 新規投与レジメン
AU2014333979B2 (en) 2013-10-07 2018-02-15 Novo Nordisk A/S Novel derivative of an insulin analogue
AU2015359376B2 (en) 2014-12-12 2021-09-09 Sanofi-Aventis Deutschland Gmbh Insulin glargine/lixisenatide fixed ratio formulation
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
GB201607918D0 (en) 2016-05-06 2016-06-22 Arecor Ltd Novel formulations
ES2886837T3 (es) 2016-12-16 2021-12-21 Novo Nordisk As Composiciones farmacéuticas que contienen insulina
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
US12343383B2 (en) 2019-07-12 2025-07-01 Novo Nordisk A/S High concentration insulin formulation

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FI78616C (fi) * 1982-02-05 1989-09-11 Novo Industri As Foerfarande foer framstaellning av en foer infusionsaendamaol avsedd stabiliserad insulinloesning, som har en foerhoejd zinkhalt.
US5506203C1 (en) * 1993-06-24 2001-02-06 Astra Ab Systemic administration of a therapeutic preparation
US5504188A (en) * 1994-06-16 1996-04-02 Eli Lilly And Company Preparation of stable zinc insulin analog crystals
US5474978A (en) * 1994-06-16 1995-12-12 Eli Lilly And Company Insulin analog formulations
ATE369146T1 (de) * 1996-06-20 2007-08-15 Novo Nordisk As Insulinpreparation mit mannitol
JP2001518915A (ja) * 1997-03-20 2001-10-16 ノボ ノルディスク アクティーゼルスカブ インシュリンと吸収増強剤の共沈殿による治療用粉末の調整法
ATE219942T1 (de) * 1997-03-20 2002-07-15 Novo Nordisk As Therapeutische pulverformulierung zur pulmonaren anwendung, welche kristallines insulin enthält

Also Published As

Publication number Publication date
CA2346969A1 (en) 2000-04-27
DE69920767T2 (de) 2006-02-02
EP1172114B1 (de) 2004-09-29
AU6188999A (en) 2000-05-08
IL142011A0 (en) 2002-03-10
HUP0104111A2 (hu) 2002-04-29
RU2218935C2 (ru) 2003-12-20
PT1172114E (pt) 2005-02-28
PT1121144E (pt) 2002-11-29
EP1172114A2 (de) 2002-01-16
CN1323219A (zh) 2001-11-21
DE69901726T2 (de) 2002-12-19
AU758146B2 (en) 2003-03-13
NO20011842D0 (no) 2001-04-10
ES2177323T3 (es) 2002-12-01
NO20011842L (no) 2001-06-15
TWI223597B (en) 2004-11-11
IL142011A (en) 2007-07-04
UA65636C2 (uk) 2004-04-15
KR100617286B1 (ko) 2006-08-30
JP4212240B2 (ja) 2009-01-21
ATE218364T1 (de) 2002-06-15
DE69901726D1 (de) 2002-07-11
EP1172114A3 (de) 2003-07-23
DK1172114T3 (da) 2005-01-24
ES2228728T3 (es) 2005-04-16
EP1121144A1 (de) 2001-08-08
ZA200102105B (en) 2001-10-12
CN1210058C (zh) 2005-07-13
NO323365B1 (no) 2007-04-10
KR20010075631A (ko) 2001-08-09
PL347210A1 (en) 2002-03-25
CZ20011134A3 (cs) 2001-08-15
WO2000023098A1 (en) 2000-04-27
EP1121144B1 (de) 2002-06-05
PL197504B1 (pl) 2008-04-30
JP2002527487A (ja) 2002-08-27
BR9914585A (pt) 2001-07-03
HUP0104111A3 (en) 2002-05-28
DE69920767D1 (de) 2004-11-04
DK1121144T3 (da) 2002-09-23

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