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BR9709845A - Preparação aquosa de insulina formulação farmacêutica parenteral e processo para aumentar a estabilidade química de uma preparação de insulina - Google Patents

Preparação aquosa de insulina formulação farmacêutica parenteral e processo para aumentar a estabilidade química de uma preparação de insulina

Info

Publication number
BR9709845A
BR9709845A BR9709845A BR9709845A BR9709845A BR 9709845 A BR9709845 A BR 9709845A BR 9709845 A BR9709845 A BR 9709845A BR 9709845 A BR9709845 A BR 9709845A BR 9709845 A BR9709845 A BR 9709845A
Authority
BR
Brazil
Prior art keywords
insulin
preparation
chemical stability
increase
pharmaceutical formulation
Prior art date
Application number
BR9709845A
Other languages
English (en)
Other versions
BR9709845B1 (pt
Inventor
Elsebeth Norup
Liselotte Langkjaer
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8096378&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR9709845(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk As filed Critical Novo Nordisk As
Publication of BR9709845A publication Critical patent/BR9709845A/pt
Publication of BR9709845B1 publication Critical patent/BR9709845B1/pt

Links

Classifications

    • 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
    • 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
    • A61K47/26—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
BRPI9709845-0A 1996-06-20 1997-06-19 preparaÇço aquosa de insulina, formulaÇço farmacÊutica parenteral, e, processso para aumentar a estabilidade quÍmica de uma preparaÇço de insulina. BR9709845B1 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK68596 1996-06-20
PCT/DK1997/000268 WO1997048414A1 (en) 1996-06-20 1997-06-19 INSULIN PREPARATIONS CONTAINING NaCl

Publications (2)

Publication Number Publication Date
BR9709845A true BR9709845A (pt) 1999-08-10
BR9709845B1 BR9709845B1 (pt) 2008-11-18

Family

ID=8096378

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI9709845-0A BR9709845B1 (pt) 1996-06-20 1997-06-19 preparaÇço aquosa de insulina, formulaÇço farmacÊutica parenteral, e, processso para aumentar a estabilidade quÍmica de uma preparaÇço de insulina.

Country Status (21)

Country Link
EP (1) EP0921812B2 (pt)
JP (2) JP4404380B2 (pt)
KR (1) KR100451778B1 (pt)
CN (1) CN1120019C (pt)
AT (1) ATE208208T1 (pt)
AU (1) AU720484B2 (pt)
BR (1) BR9709845B1 (pt)
CA (1) CA2258097C (pt)
CZ (1) CZ297937B6 (pt)
DE (1) DE69708121T3 (pt)
DK (1) DK0921812T4 (pt)
ES (1) ES2167751T5 (pt)
HU (1) HU228094B1 (pt)
IL (2) IL127366A0 (pt)
NO (1) NO324430B1 (pt)
PL (1) PL189964B1 (pt)
PT (1) PT921812E (pt)
RU (1) RU2182015C2 (pt)
UA (1) UA49890C2 (pt)
WO (1) WO1997048414A1 (pt)
ZA (1) ZA975470B (pt)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1044016B1 (en) * 1998-01-09 2005-03-16 Novo Nordisk A/S Stabilised insulin compositions
JP2002529514A (ja) * 1998-11-18 2002-09-10 ノボ ノルディスク アクティーゼルスカブ フェノール及びクレゾールを要さない安定なインスリン水性調製物
US6489292B1 (en) 1998-11-18 2002-12-03 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
ES2180511T3 (es) * 1999-01-26 2003-02-16 Lilly Co Eli Formulaciones monodispersas de analogos de insulina acilados hexamericos.
WO2000059499A1 (en) * 1999-04-05 2000-10-12 Verteletsky, Pavel Vasilievich Use of succinic acid or salts thereof for the treatment of diabetes mellitus and wound healing
EP1523993A1 (en) * 1999-12-16 2005-04-20 Eli Lilly & Company Polypeptide compositions with improved stability
ATE288765T1 (de) * 1999-12-16 2005-02-15 Lilly Co Eli Polypeptidzusammensetzungen mit verbesserter stabilität
US7022674B2 (en) 1999-12-16 2006-04-04 Eli Lilly And Company Polypeptide compositions with improved stability
ES2544329T3 (es) 2004-10-05 2015-08-28 Novo Nordisk A/S Una formulación farmacéutica que contiene insulina cristalina e insulina disuelta
RU2288000C1 (ru) * 2005-04-27 2006-11-27 Институт нефтехимического синтеза им. А.В. Топчиева РАН (ИНХС РАН) Раствор инсулина для перорального введения
CN103736082A (zh) 2008-10-17 2014-04-23 赛诺菲-安万特德国有限公司 胰岛素和glp-1激动剂的组合
CN102711804B (zh) 2009-11-13 2015-09-16 赛诺菲-安万特德国有限公司 包含glp-1激动剂和甲硫氨酸的药物组合物
AU2010317995B2 (en) 2009-11-13 2014-04-17 Sanofi-Aventis Deutschland Gmbh Pharmaceutical composition comprising a GLP-1 agonist, an insulin, and methionine
PT2611458T (pt) 2010-08-30 2016-12-16 Sanofi Aventis Deutschland Utilização de ave0010 para o fabrico de um medicamento para o tratamento da diabetes mellitus tipo 2
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
ES2550357T3 (es) 2011-08-29 2015-11-06 Sanofi-Aventis Deutschland Gmbh Combinación farmacéutica para su uso en el control glucémico en pacientes de 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
CN104870469A (zh) * 2012-12-26 2015-08-26 沃克哈特有限公司 药物组合物
TWI641381B (zh) 2013-02-04 2018-11-21 法商賽諾菲公司 胰島素類似物及／或胰島素衍生物之穩定化醫藥調配物
JP2020143105A (ja) * 2014-01-09 2020-09-10 サノフイＳａｎｏｆｉ インスリンアスパルトの安定化された医薬製剤
JP6735674B2 (ja) * 2014-01-09 2020-08-05 サノフイＳａｎｏｆｉ インスリンアスパルトの安定化された医薬製剤
KR20160104726A (ko) 2014-01-09 2016-09-05 사노피 인슐린 유사체 및/또는 인슐린 유도체의 안정화된 무글리세롤 약제학적 제형
JP2020114861A (ja) * 2014-01-09 2020-07-30 サノフイＳａｎｏｆｉ インスリンアナログおよび／またはインスリン誘導体の、グリセリンを含まない安定化された医薬製剤
RU2016132342A (ru) 2014-01-09 2018-02-14 Санофи Стабилизированные фармацевтические составы на основе инсулиновых аналогов и/или инсулиновых производных
KR102578030B1 (ko) 2014-12-12 2023-09-14 사노피-아벤티스 도이칠란트 게엠베하 인슐린 글라진／릭시세나티드 고정비 제형
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
CA3196481A1 (en) * 2020-11-16 2022-05-19 W. L. Gore & Associates, Inc. Formulations, methods, and pre-filled multi-dose injection devices without cloud point

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK116527B (da) * 1967-03-01 1970-01-19 Nordisk Insulinlab Fremgangsmåde til fremstilling af en hurtigtvirkende, holdbar, neutral opløsning af rent krystallinsk okseinsulin eller okseinsulin, der ved tilsætning af Zn er krystalliserbart i vand, eller blandinger af okseinsulin og insulin af anden oprindelse.
SU1528496A1 (ru) * 1972-10-17 1989-12-15 Днепропетровский Научно-Исследовательский Институт Гастроэнтерологии Дегидратирующее средство
US4783441A (en) † 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
US4439181A (en) * 1981-01-26 1984-03-27 Regents Of The University Of Minnesota Polyol-hormone mixture for use in chronic parenteral hormone administration
AU550068B2 (en) † 1981-03-10 1986-02-27 Novo Nordisk A/S Zinc insulin stabilized with calcium or magnesium salts
US4839341A (en) * 1984-05-29 1989-06-13 Eli Lilly And Company Stabilized insulin formulations
PH25772A (en) * 1985-08-30 1991-10-18 Novo Industri As Insulin analogues, process for their preparation
IL93282A (en) * 1989-02-09 1995-08-31 Lilly Co Eli Insulin analogues
EP0705275B1 (en) * 1993-06-21 1999-02-03 Novo Nordisk A/S Asp-b28 insulin crystals
KR100310122B1 (ko) * 1993-09-17 2002-04-24 한센 핀 베네드, 안네 제헤르, 웨이콥 마리안느 아실화된인슐린
US5474978A (en) * 1994-06-16 1995-12-12 Eli Lilly And Company Insulin analog formulations
US5461031A (en) * 1994-06-16 1995-10-24 Eli Lilly And Company Monomeric insulin analog formulations

Also Published As

Publication number Publication date
ATE208208T1 (de) 2001-11-15
AU3253697A (en) 1998-01-07
AU720484B2 (en) 2000-06-01
IL127366A (en) 2007-07-04
BR9709845B1 (pt) 2008-11-18
CN1120019C (zh) 2003-09-03
HUP9904031A3 (en) 2000-10-30
EP0921812A1 (en) 1999-06-16
IL127366A0 (en) 1999-10-28
NO985981D0 (no) 1998-12-18
ES2167751T3 (es) 2002-05-16
HU228094B1 (en) 2012-10-29
UA49890C2 (uk) 2002-10-15
PL189964B1 (pl) 2005-10-31
CN1222083A (zh) 1999-07-07
JP2009235075A (ja) 2009-10-15
CZ297937B6 (cs) 2007-05-02
JP2000513344A (ja) 2000-10-10
EP0921812B1 (en) 2001-11-07
CZ395698A3 (cs) 1999-05-12
DE69708121T3 (de) 2012-05-16
PL330763A1 (en) 1999-05-24
DK0921812T4 (da) 2012-04-02
DK0921812T3 (da) 2002-02-11
WO1997048414A1 (en) 1997-12-24
PT921812E (pt) 2002-04-29
EP0921812B2 (en) 2011-12-21
RU2182015C2 (ru) 2002-05-10
ZA975470B (en) 1997-12-22
NO324430B1 (no) 2007-10-15
NO985981L (no) 1998-12-18
CA2258097C (en) 2011-02-08
JP4404380B2 (ja) 2010-01-27
DE69708121T2 (de) 2002-08-01
KR20000022031A (ko) 2000-04-25
DE69708121D1 (de) 2001-12-13
CA2258097A1 (en) 1997-12-24
HUP9904031A2 (hu) 2000-04-28
ES2167751T5 (es) 2012-03-30
KR100451778B1 (ko) 2004-11-16

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B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
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