DK1172114T3 - Stabile koncentrerede insulinpræparater til pulmonær indgivelse - Google Patents

Stabile koncentrerede insulinpræparater til pulmonær indgivelse

Info

Publication number
DK1172114T3
DK1172114T3 DK01126054T DK01126054T DK1172114T3 DK 1172114 T3 DK1172114 T3 DK 1172114T3 DK 01126054 T DK01126054 T DK 01126054T DK 01126054 T DK01126054 T DK 01126054T DK 1172114 T3 DK1172114 T3 DK 1172114T3
Authority
DK
Denmark
Prior art keywords
pulmonary administration
insulin preparations
stable concentrated
concentrated insulin
formulations
Prior art date
Application number
DK01126054T
Other languages
Danish (da)
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 DK1172114T3 publication Critical patent/DK1172114T3/da

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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/28Steroids, 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)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dispersion Chemistry (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DK01126054T 1998-10-16 1999-10-15 Stabile koncentrerede insulinpræparater til pulmonær indgivelse DK1172114T3 (da)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
DK1172114T3 true DK1172114T3 (da) 2005-01-24

Family

ID=8103620

Family Applications (2)

Application Number Title Priority Date Filing Date
DK01126054T DK1172114T3 (da) 1998-10-16 1999-10-15 Stabile koncentrerede insulinpræparater til pulmonær indgivelse
DK99948725T DK1121144T3 (da) 1998-10-16 1999-10-15 Stabile koncentrerede insulinpræparater til pulmonar indgivelse

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK99948725T DK1121144T3 (da) 1998-10-16 1999-10-15 Stabile koncentrerede insulinpræparater til pulmonar indgivelse

Country Status (22)

Country Link
EP (2) EP1121144B1 (de)
JP (1) JP4212240B2 (de)
KR (1) KR100617286B1 (de)
CN (1) CN1210058C (de)
AT (2) ATE277630T1 (de)
AU (1) AU758146B2 (de)
BR (1) BR9914585A (de)
CA (1) CA2346969A1 (de)
CZ (1) CZ20011134A3 (de)
DE (2) DE69920767T2 (de)
DK (2) DK1172114T3 (de)
ES (2) ES2177323T3 (de)
HU (1) HUP0104111A3 (de)
IL (2) IL142011A0 (de)
NO (1) NO323365B1 (de)
PL (1) PL197504B1 (de)
PT (2) PT1121144E (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
EP1270012A1 (de) * 2001-06-21 2003-01-02 Pfizer Products Inc. Verwendung pulmonär verabreichten Insulins zur Behandlung von Diabetes
AU2003236201A1 (en) 2002-05-07 2003-11-11 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
CN100353997C (zh) * 2003-02-28 2007-12-12 中外制药株式会社 稳定的含蛋白质的制剂
MXPA05009565A (es) * 2003-03-11 2005-12-02 Novo Nordisk As Preparaciones farmaceuticas que comprenden insulina estabilizada con acido.
EP2107069B1 (de) 2003-08-05 2013-01-16 Novo Nordisk A/S Neuartige Insulinderivate
ES2371361T3 (es) * 2005-12-28 2011-12-30 Novo Nordisk A/S Composiciones que comprenden una insulina acilada y zinc y método de producción de dichas composiciones.
CN101573133B (zh) 2006-07-31 2014-08-27 诺沃-诺迪斯克有限公司 Peg化延长的胰岛素
JP5864834B2 (ja) 2006-09-22 2016-02-17 ノボ・ノルデイスク・エー/エス プロテアーゼ耐性のインスリンアナログ
US20100120660A1 (en) * 2007-04-30 2010-05-13 Per Balschmidt Highly concentrated insulin solutions and compositions
EP2152245B1 (de) 2007-04-30 2015-12-02 Novo Nordisk A/S Verfahren zum Trocknen einer Proteinzusammensetzung, getrocknete Proteinzusammensetzung und pharmazeutische Zusammensetzungen mit dem getrockneten Protein
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
EP2254905B1 (de) 2008-03-14 2016-12-14 Novo Nordisk A/S Proteasestabilisierte insulinanaloga
EP2910570B1 (de) 2008-03-18 2016-10-12 Novo Nordisk A/S Proteasestabilisierte, acylierte Insulinanaloga
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
AU2011235959C1 (en) * 2008-06-13 2013-10-10 Eli Lilly And Company PEGylated insulin lispro compounds
HUE037449T2 (hu) 2008-10-17 2018-08-28 Sanofi Aventis Deutschland Egy inzulin és egy GLP-1 agonista kombinációja
US9603904B2 (en) 2008-10-30 2017-03-28 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
RU2573995C2 (ru) 2009-11-13 2016-01-27 Санофи-Авентис Дойчланд Гмбх Фармацевтическая композиция, содержащая агонист гпп-1 и метионин
SI2554183T1 (en) 2009-11-13 2018-08-31 Sanofi-Aventis Deutschland Gmbh A pharmaceutical composition comprising the GLP-1 agonist and insulin and methionine
SI2611458T1 (sl) 2010-08-30 2017-01-31 Sanofi-Aventis Deutschland Gmbh Uporaba AVE0010 za izdelavo zdravila za zdravljenje sladkorne bolezni tipa 2
JP6049625B2 (ja) 2010-10-27 2016-12-21 ノヴォ ノルディスク アー/エス 様々な注射間隔を用いて施されるインスリン注射を使用する、真性糖尿病の治療
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
PT2750699E (pt) 2011-08-29 2015-11-03 Sanofi Aventis Deutschland Acelerómetro pendular
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
ES2594303T3 (es) 2012-04-11 2016-12-19 Novo Nordisk A/S Formulaciones de insulina
AU2013368990B2 (en) * 2012-12-26 2017-05-18 Wockhardt Limited Pharmaceutical composition
DK2983697T3 (en) 2013-04-03 2019-02-25 Sanofi Sa TREATMENT OF DIABETES MELLITUS WITH LONG-EFFECTIVE FORMULATIONS OF INSULIN
EP2991672A1 (de) 2013-04-30 2016-03-09 Novo Nordisk A/S Neuartiges verabreichungsschema
MX366636B (es) 2013-10-07 2019-07-17 Novo Nordisk As Nuevo derivado de un análogo de insulina.
JP6970615B2 (ja) 2014-12-12 2021-11-24 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング インスリングラルギン/リキシセナチド固定比処方
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
US20180169190A1 (en) 2016-12-16 2018-06-21 Novo Nordisk A/S Insulin containing pharmaceutical compositions
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
US20220249619A1 (en) * 2019-07-12 2022-08-11 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
US5474978A (en) * 1994-06-16 1995-12-12 Eli Lilly And Company Insulin analog formulations
US5504188A (en) * 1994-06-16 1996-04-02 Eli Lilly And Company Preparation of stable zinc insulin analog crystals
ES2292189T3 (es) * 1996-06-20 2008-03-01 Novo Nordisk A/S Preparaciones a base de insulina conteniendo manitol.
DE69806362T2 (de) * 1997-03-20 2003-01-30 Novo Nordisk As Therapeutische pulverformulierung zur pulmonaren anwendung, welche kristallines insulin enthält
AU6611898A (en) * 1997-03-20 1998-10-20 Novo Nordisk A/S Method for preparation of a therapeutic powder through coprecipitation of insulin and absorption enhancer

Also Published As

Publication number Publication date
EP1172114B1 (de) 2004-09-29
EP1172114A2 (de) 2002-01-16
PL197504B1 (pl) 2008-04-30
ES2228728T3 (es) 2005-04-16
HUP0104111A3 (en) 2002-05-28
KR100617286B1 (ko) 2006-08-30
DE69901726D1 (de) 2002-07-11
ES2177323T3 (es) 2002-12-01
DE69920767D1 (de) 2004-11-04
HUP0104111A2 (hu) 2002-04-29
CA2346969A1 (en) 2000-04-27
CN1323219A (zh) 2001-11-21
RU2218935C2 (ru) 2003-12-20
IL142011A (en) 2007-07-04
PT1172114E (pt) 2005-02-28
ATE277630T1 (de) 2004-10-15
UA65636C2 (uk) 2004-04-15
BR9914585A (pt) 2001-07-03
TWI223597B (en) 2004-11-11
AU758146B2 (en) 2003-03-13
WO2000023098A1 (en) 2000-04-27
NO20011842D0 (no) 2001-04-10
CN1210058C (zh) 2005-07-13
AU6188999A (en) 2000-05-08
ATE218364T1 (de) 2002-06-15
DE69920767T2 (de) 2006-02-02
EP1121144A1 (de) 2001-08-08
DK1121144T3 (da) 2002-09-23
NO323365B1 (no) 2007-04-10
JP4212240B2 (ja) 2009-01-21
NO20011842L (no) 2001-06-15
JP2002527487A (ja) 2002-08-27
ZA200102105B (en) 2001-10-12
DE69901726T2 (de) 2002-12-19
PL347210A1 (en) 2002-03-25
PT1121144E (pt) 2002-11-29
CZ20011134A3 (cs) 2001-08-15
IL142011A0 (en) 2002-03-10
EP1121144B1 (de) 2002-06-05
EP1172114A3 (de) 2003-07-23
KR20010075631A (ko) 2001-08-09

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