DE69901726D1 - Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung - Google Patents

Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung

Info

Publication number
DE69901726D1
DE69901726D1 DE69901726T DE69901726T DE69901726D1 DE 69901726 D1 DE69901726 D1 DE 69901726D1 DE 69901726 T DE69901726 T DE 69901726T DE 69901726 T DE69901726 T DE 69901726T DE 69901726 D1 DE69901726 D1 DE 69901726D1
Authority
DE
Germany
Prior art keywords
pulmonary administration
insulin preparations
stable concentrated
concentrated insulin
formulations
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
DE69901726T
Other languages
English (en)
Other versions
DE69901726T2 (de
Inventor
Svend Havelund
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
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
Publication of DE69901726D1 publication Critical patent/DE69901726D1/de
Application granted granted Critical
Publication of DE69901726T2 publication Critical patent/DE69901726T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (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)
DE69901726T 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung Expired - Lifetime DE69901726T2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA199801327 1998-10-16
PCT/DK1999/000556 WO2000023098A1 (en) 1998-10-16 1999-10-15 Stable concentrated insulin preparations for pulmonary delivery

Publications (2)

Publication Number Publication Date
DE69901726D1 true DE69901726D1 (de) 2002-07-11
DE69901726T2 DE69901726T2 (de) 2002-12-19

Family

ID=8103620

Family Applications (2)

Application Number Title Priority Date Filing Date
DE69901726T Expired - Lifetime DE69901726T2 (de) 1998-10-16 1999-10-15 Stabile konzentrierte insulin präparationen zur pulmonaren verabreichung
DE69920767T Expired - Lifetime DE69920767T2 (de) 1998-10-16 1999-10-15 Stabile konzentrierte Insulin Präparationen zur pulmonaren Verabreichung

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE69920767T Expired - Lifetime DE69920767T2 (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) ATE277630T1 (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) PT1121144E (de)
RU (1) RU2218935C2 (de)
TW (1) TWI223597B (de)
UA (1) UA65636C2 (de)
WO (1) WO2000023098A1 (de)
ZA (1) ZA200102105B (de)

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
CA2517310C (en) * 2003-02-28 2015-11-24 Chugai Seiyaku Kabushiki Kaisha Stabilized protein-containing formulations comprising a poloxamer
WO2004080480A1 (en) * 2003-03-11 2004-09-23 Novo Nordisk A/S Pharmaceutical preparations comprising acid-stabilised insulin
MXPA06001283A (es) 2003-08-05 2006-04-11 Novo Nordisk As Derivados de insulina novedosos.
WO2007074133A2 (en) * 2005-12-28 2007-07-05 Novo Nordisk A/S Compositions comprising an acylated insulin and zinc and method of making the said compositions
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
EP2404934A1 (de) 2006-09-22 2012-01-11 Novo Nordisk A/S Proteaseresistente Insulinanaloga
WO2008132229A2 (en) * 2007-04-30 2008-11-06 Novo Nordisk A/S Highly concentrated insulin solutions and compositions
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
ES2744384T3 (es) * 2007-06-13 2020-02-24 Novo Nordisk As Formulación farmacéutica que comprende un derivado de insulina
WO2009112583A2 (en) 2008-03-14 2009-09-17 Novo Nordisk A/S Protease-stabilized insulin analogues
AU2009226910B2 (en) 2008-03-18 2014-02-06 Novo Nordisk A/S Protease stabilized, acylated insulin analogues
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
CN107308442B (zh) 2009-11-13 2022-10-18 赛诺菲-安万特德国有限公司 包含glp-1激动剂、胰岛素和甲硫氨酸的药物组合物
PT3345593T (pt) 2009-11-13 2023-11-27 Sanofi Aventis Deutschland Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina
LT2611458T (lt) 2010-08-30 2016-12-27 Sanofi-Aventis Deutschland Gmbh Ave0010 panaudojimas gaminant vaistą, skirtą 2 tipo cukrinio diabeto gydymui
RU2013123515A (ru) 2010-10-27 2014-12-10 Ново Нордиск А/С Лечение сахарного диабета с помощью инъекций инсулина, вводимых с различными интервалами
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
MX370264B (es) 2011-08-29 2019-12-09 Sanofi Aventis Deutschland Combinacion farmaceutica para uso en el control glucemico en pacientes con diabetes de tipo 2.
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
AU2013247047A1 (en) 2012-04-11 2014-10-23 Novo Nordisk A/S Insulin formulations
WO2014102623A1 (en) * 2012-12-26 2014-07-03 Wockhardt Limited Pharmaceutical composition
UA117480C2 (uk) 2013-04-03 2018-08-10 Санофі Лікування цукрового діабету за допомогою складу інсуліну тривалої дії
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
JP6499184B2 (ja) 2013-10-07 2019-04-10 ノヴォ ノルディスク アー/エス インスリン類似体の新規な誘導体
SI3229828T1 (sl) 2014-12-12 2023-06-30 Sanofi-Aventis Deutschland Gmbh Formulacija s fiksnim razmerjem inzulin glargin/liksisenatid
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
BR112019011761A2 (pt) 2016-12-16 2019-11-05 Novo Nordisk As composições farmacêuticas contendo insulina
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

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EP0910402B1 (de) * 1996-06-20 2007-08-08 Novo Nordisk A/S INSULINPREPARATION MIT MAnnitol
AU6611998A (en) * 1997-03-20 1998-10-20 Novo Nordisk A/S Therapeutic powder formulation for pulmonary administration, containing crystalline insulin
DE69806582T2 (de) * 1997-03-20 2003-02-13 Novo Nordisk As Verfahren zur herstellung eines therapeutischen puders durch copräzipitation von insulin und einem absorptionsverstärker

Also Published As

Publication number Publication date
DK1121144T3 (da) 2002-09-23
BR9914585A (pt) 2001-07-03
PT1121144E (pt) 2002-11-29
IL142011A0 (en) 2002-03-10
PL197504B1 (pl) 2008-04-30
HUP0104111A2 (hu) 2002-04-29
AU758146B2 (en) 2003-03-13
IL142011A (en) 2007-07-04
ZA200102105B (en) 2001-10-12
UA65636C2 (uk) 2004-04-15
ATE218364T1 (de) 2002-06-15
JP2002527487A (ja) 2002-08-27
DE69920767D1 (de) 2004-11-04
JP4212240B2 (ja) 2009-01-21
DK1172114T3 (da) 2005-01-24
HUP0104111A3 (en) 2002-05-28
KR20010075631A (ko) 2001-08-09
CN1210058C (zh) 2005-07-13
EP1172114A3 (de) 2003-07-23
CN1323219A (zh) 2001-11-21
ATE277630T1 (de) 2004-10-15
DE69901726T2 (de) 2002-12-19
DE69920767T2 (de) 2006-02-02
CZ20011134A3 (cs) 2001-08-15
KR100617286B1 (ko) 2006-08-30
EP1121144A1 (de) 2001-08-08
NO323365B1 (no) 2007-04-10
CA2346969A1 (en) 2000-04-27
NO20011842L (no) 2001-06-15
EP1172114A2 (de) 2002-01-16
AU6188999A (en) 2000-05-08
EP1172114B1 (de) 2004-09-29
ES2177323T3 (es) 2002-12-01
PL347210A1 (en) 2002-03-25
EP1121144B1 (de) 2002-06-05
WO2000023098A1 (en) 2000-04-27
RU2218935C2 (ru) 2003-12-20
NO20011842D0 (no) 2001-04-10
TWI223597B (en) 2004-11-11
PT1172114E (pt) 2005-02-28
ES2228728T3 (es) 2005-04-16

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