BR9914585A - Formulação aquosa de insulina, preparação de insulina, e, método de tratamento de diabetes do tipo i ou do tipo ii - Google Patents

Formulação aquosa de insulina, preparação de insulina, e, método de tratamento de diabetes do tipo i ou do tipo ii

Info

Publication number
BR9914585A
BR9914585A BR9914585-5A BR9914585A BR9914585A BR 9914585 A BR9914585 A BR 9914585A BR 9914585 A BR9914585 A BR 9914585A BR 9914585 A BR9914585 A BR 9914585A
Authority
BR
Brazil
Prior art keywords
insulin
type
diabetes
preparation
molecules
Prior art date
Application number
BR9914585-5A
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
Publication of BR9914585A publication Critical patent/BR9914585A/pt

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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Otolaryngology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

"FORMULAçãO AQUOSA DE INSULINA, PREPARAçãO DE INSULINA, E, MéTODO DE TRATAMENTO DE DIABETES DO TIPO I OU DO TIPO II" São apresentadas formulações concentradas de insulina aquosa de alta estabilidade física e química. As formulações são adequadas para a administração pulmonar. O objetivo foi conseguido pelo fornecimento de uma formulação de insulina na qual a concentração de cloreto é mantida abaixo de 50 mM, e na qual a concentração de outros ânions como fosfato é minimizada. A formulação aquosa de insulina compreende 3 a 20 mM de insulina humana ou um análogo ou um derivado da mesma, menos de 50 mM de cloreto, menos de 10 mM de quaisquer ânions diferentes de cloreto e acetato, 2 a 5 íons Zn^ 2+^ por 6 moléculas de insulina, e pelo menos 3 moléculas fenólicas por 6 moléculas de insulina.
BR9914585-5A 1998-10-16 1999-10-15 Formulação aquosa de insulina, preparação de insulina, e, método de tratamento de diabetes do tipo i ou do tipo ii BR9914585A (pt)

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 (1)

Publication Number Publication Date
BR9914585A true BR9914585A (pt) 2001-07-03

Family

ID=8103620

Family Applications (1)

Application Number Title Priority Date Filing Date
BR9914585-5A BR9914585A (pt) 1998-10-16 1999-10-15 Formulação aquosa de insulina, preparação de insulina, e, método de tratamento de diabetes do tipo i ou do tipo ii

Country Status (22)

Country Link
EP (2) EP1121144B1 (pt)
JP (1) JP4212240B2 (pt)
KR (1) KR100617286B1 (pt)
CN (1) CN1210058C (pt)
AT (2) ATE277630T1 (pt)
AU (1) AU758146B2 (pt)
BR (1) BR9914585A (pt)
CA (1) CA2346969A1 (pt)
CZ (1) CZ20011134A3 (pt)
DE (2) DE69920767T2 (pt)
DK (2) DK1121144T3 (pt)
ES (2) ES2177323T3 (pt)
HU (1) HUP0104111A3 (pt)
IL (2) IL142011A0 (pt)
NO (1) NO323365B1 (pt)
PL (1) PL197504B1 (pt)
PT (2) PT1121144E (pt)
RU (1) RU2218935C2 (pt)
TW (1) TWI223597B (pt)
UA (1) UA65636C2 (pt)
WO (1) WO2000023098A1 (pt)
ZA (1) ZA200102105B (pt)

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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
JP4607010B2 (ja) 2003-02-28 2011-01-05 中外製薬株式会社 タンパク質含有安定化製剤
WO2004080480A1 (en) * 2003-03-11 2004-09-23 Novo Nordisk A/S Pharmaceutical preparations comprising acid-stabilised insulin
EP2264065B1 (en) 2003-08-05 2017-03-08 Novo Nordisk A/S Novel insulin derivatives
CN101389650B (zh) 2005-12-28 2012-10-10 诺沃-诺迪斯克有限公司 包含酰化胰岛素和锌的组合物以及制备所述组合物的方法
EP2049149B1 (en) 2006-07-31 2015-04-15 Novo Nordisk A/S Pegylated extended insulins
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
US9387176B2 (en) 2007-04-30 2016-07-12 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried 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
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
PT2254906T (pt) 2008-03-18 2017-01-03 Novo Nordisk As Análogos de insulina acilados, estabilizados contra proteases
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
KR101820024B1 (ko) 2008-10-17 2018-01-18 사노피-아벤티스 도이칠란트 게엠베하 인슐린과 glp-1 효능제의 병용물
US9603904B2 (en) 2008-10-30 2017-03-28 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
ES2534191T3 (es) 2009-11-13 2015-04-20 Sanofi-Aventis Deutschland Gmbh Composición farmacéutica que comprende un agonista de GLP-1, una insulina y metionina
HUE037735T2 (hu) 2009-11-13 2018-09-28 Sanofi Aventis Deutschland DesPro36exendin-4(1-39)-Lys6-NH2-t és metionint tartalmazó gyógyszerkészítmény
BR112013004756B1 (pt) 2010-08-30 2020-04-28 Sanofi Aventis Deutschland uso de ave0010 para a fabricação de um medicamento para o tratamento da diabetes melito tipo 2
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
RU2650616C2 (ru) 2011-08-29 2018-04-16 Санофи-Авентис Дойчланд Гмбх Фармацевтическая комбинация для применения при гликемическом контроле у пациентов с сахарным диабетом 2 типа
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
CA2870313A1 (en) 2012-04-11 2013-10-17 Novo Nordisk A/S Insulin formulations
MX2015006997A (es) * 2012-12-26 2015-09-23 Wockhardt Ltd Composicion farmaceutica.
DK2983697T3 (en) 2013-04-03 2019-02-25 Sanofi Sa TREATMENT OF DIABETES MELLITUS WITH LONG-EFFECTIVE FORMULATIONS OF INSULIN
EP2991672A1 (en) 2013-04-30 2016-03-09 Novo Nordisk A/S Novel administration regime
AU2014333979B2 (en) 2013-10-07 2018-02-15 Novo Nordisk A/S Novel derivative of an insulin analogue
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
CN110087674B (zh) 2016-12-16 2023-01-03 诺和诺德股份有限公司 含胰岛素的药物组合物
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
CN114096269B (zh) * 2019-07-12 2024-06-11 诺和诺德股份有限公司 高浓度胰岛素制剂

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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.
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ATE369146T1 (de) * 1996-06-20 2007-08-15 Novo Nordisk As Insulinpreparation mit mannitol
ATE220555T1 (de) * 1997-03-20 2002-08-15 Novo Nordisk As Verfahren zur herstellung eines therapeutischen puders durch copräzipitation von insulin und einem absorptionsverstärker
AU6611998A (en) * 1997-03-20 1998-10-20 Novo Nordisk A/S Therapeutic powder formulation for pulmonary administration, containing crystalline insulin

Also Published As

Publication number Publication date
IL142011A (en) 2007-07-04
WO2000023098A1 (en) 2000-04-27
DK1121144T3 (da) 2002-09-23
UA65636C2 (uk) 2004-04-15
DK1172114T3 (da) 2005-01-24
NO20011842L (no) 2001-06-15
DE69901726T2 (de) 2002-12-19
CN1323219A (zh) 2001-11-21
EP1121144A1 (en) 2001-08-08
DE69901726D1 (de) 2002-07-11
EP1121144B1 (en) 2002-06-05
EP1172114B1 (en) 2004-09-29
NO323365B1 (no) 2007-04-10
CN1210058C (zh) 2005-07-13
JP4212240B2 (ja) 2009-01-21
DE69920767D1 (de) 2004-11-04
PL197504B1 (pl) 2008-04-30
DE69920767T2 (de) 2006-02-02
TWI223597B (en) 2004-11-11
HUP0104111A3 (en) 2002-05-28
CA2346969A1 (en) 2000-04-27
HUP0104111A2 (hu) 2002-04-29
ATE218364T1 (de) 2002-06-15
AU758146B2 (en) 2003-03-13
ATE277630T1 (de) 2004-10-15
AU6188999A (en) 2000-05-08
ES2228728T3 (es) 2005-04-16
IL142011A0 (en) 2002-03-10
PT1172114E (pt) 2005-02-28
RU2218935C2 (ru) 2003-12-20
NO20011842D0 (no) 2001-04-10
CZ20011134A3 (cs) 2001-08-15
PT1121144E (pt) 2002-11-29
EP1172114A3 (en) 2003-07-23
ES2177323T3 (es) 2002-12-01
EP1172114A2 (en) 2002-01-16
JP2002527487A (ja) 2002-08-27
ZA200102105B (en) 2001-10-12
KR20010075631A (ko) 2001-08-09
PL347210A1 (en) 2002-03-25
KR100617286B1 (ko) 2006-08-30

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Legal Events

Date Code Title Description
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements