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
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) EP1121144B1 (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) DE69901726T2 (de)
DK (2) DK1172114T3 (de)
ES (2) ES2228728T3 (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
ES2360182T3 (es) 2002-05-07 2011-06-01 Novo Nordisk A/S Formulaciones solubles que comprenden insulina monomérica e insulina acilada.
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
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
CA2531988C (en) 2003-08-05 2016-06-28 Novo Nordisk A/S Novel insulin derivatives
PT1969004E (pt) 2005-12-28 2011-11-25 Novo Nordisk As Composições que compreendem uma insulina acilada e zinco e método para criar tais composições
US20090306337A1 (en) 2006-07-31 2009-12-10 Novo Nordisk A/S Pegylated, Extended Insulins
RU2524150C2 (ru) 2006-09-22 2014-07-27 Ново Нордиск А/С Аналоги инсулина, устойчивые к протеазам
EP2152243A2 (de) * 2007-04-30 2010-02-17 Novo Nordisk A/S Hochkonzentrierte insulinlösungen und zusammensetzungen
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
US9034818B2 (en) 2007-06-13 2015-05-19 Novo Nordisk A/S Pharmaceutical formulations comprising an insulin derivative
US9260502B2 (en) 2008-03-14 2016-02-16 Novo Nordisk A/S Protease-stabilized insulin analogues
RU2571857C2 (ru) 2008-03-18 2015-12-20 Ново Нордиск А/С Стабилизированные по отношению к протеазам ацилированные аналоги инсулина
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
KR101939557B1 (ko) 2008-10-17 2019-01-17 사노피-아벤티스 도이칠란트 게엠베하 인슐린과 ｇｌｐ－1 효능제의 병용물
AU2009309623B9 (en) 2008-10-30 2014-10-02 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
RU2537239C2 (ru) 2009-11-13 2014-12-27 Санофи-Авентис Дойчланд Гмбх Фармацевтическая композиция, включающая агонист glp-1, инсулин и метионин
AU2010317994B2 (en) 2009-11-13 2014-03-06 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a GLP-1 agonist and methionine
CN103179978A (zh) 2010-08-30 2013-06-26 赛诺菲-安万特德国有限公司 Ave0010用于制造供治疗2型糖尿病用的药物的用途
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
JP6367115B2 (ja) 2011-08-29 2018-08-01 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 ２型糖尿病患者の血糖コントロールに使用する組合せ医薬
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
MX2014012096A (es) 2012-04-11 2014-11-21 Novo Nordisk As Formulaciones de insulina.
RU2015130613A (ru) * 2012-12-26 2017-01-31 Вокхардт Лимитед Фармацевтическая композиция
EP2983697B1 (de) 2013-04-03 2018-10-31 Sanofi Behandlung von diabetes mellitus durch neue dosierungen von glargine insulin
EP2991672A1 (de) 2013-04-30 2016-03-09 Novo Nordisk A/S Neuartiges verabreichungsschema
KR20160065126A (ko) 2013-10-07 2016-06-08 노보 노르디스크 에이/에스 인슐린 유사체의 신규한 유도체
NZ733670A (en) 2014-12-12 2021-12-24 Sanofi Aventis Deutschland 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
HRP20221324T1 (hr) 2016-12-16 2022-12-23 Novo Nordisk A/S Farmaceutski pripravci koji sadrže inzulin
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
WO2021009027A1 (en) * 2019-07-12 2021-01-21 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
IL127365A0 (en) * 1996-06-20 1999-10-28 Novo Nordisk As Insulin preparations containing carbohydrates
AU6611998A (en) * 1997-03-20 1998-10-20 Novo Nordisk A/S Therapeutic powder formulation for pulmonary administration, containing crystalline insulin
ATE220555T1 (de) * 1997-03-20 2002-08-15 Novo Nordisk As Verfahren zur herstellung eines therapeutischen puders durch copräzipitation von insulin und einem absorptionsverstärker

Also Published As

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

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