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BR9709845B1 - preparaÇço aquosa de insulina, formulaÇço farmacÊutica parenteral, e, processso para aumentar a estabilidade quÍmica de uma preparaÇço de insulina. - Google Patents

preparaÇço aquosa de insulina, formulaÇço farmacÊutica parenteral, e, processso para aumentar a estabilidade quÍmica de uma preparaÇço de insulina.

Info

Publication number
BR9709845B1
BR9709845B1 BRPI9709845-0A BR9709845A BR9709845B1 BR 9709845 B1 BR9709845 B1 BR 9709845B1 BR 9709845 A BR9709845 A BR 9709845A BR 9709845 B1 BR9709845 B1 BR 9709845B1
Authority
BR
Brazil
Prior art keywords
insulin preparation
chemical stability
enhancing
pharmaceutical formulation
parenteral pharmaceutical
Prior art date
Application number
BRPI9709845-0A
Other languages
English (en)
Other versions
BR9709845A (pt
Inventor
Elsebeth Norup
Liselotte Langkjaer
Svend Havelund
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(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed filed Critical
Publication of BR9709845A publication Critical patent/BR9709845A/pt
Publication of BR9709845B1 publication Critical patent/BR9709845B1/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
    • A61K47/06Organic 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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

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)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (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 BR9709845A (pt) 1999-08-10
BR9709845B1 true 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
AU1870099A (en) * 1998-01-09 1999-07-26 Novo Nordisk A/S Stabilised insulin compositions
EP1131089B1 (en) * 1998-11-18 2004-02-18 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
US6489292B1 (en) 1998-11-18 2002-12-03 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
AU2624400A (en) * 1999-01-26 2000-08-07 Eli Lilly And Company Monodisperse hexameric acylated insulin analog formulations
CA2362116A1 (en) * 1999-04-05 2000-10-12 Igor Anatolievich Pomytkin 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
EA004631B1 (ru) * 1999-12-16 2004-06-24 Эли Лилли Энд Компани Полипептидные композиции, обладающие повышенной стабильностью
US7022674B2 (en) 1999-12-16 2006-04-04 Eli Lilly And Company Polypeptide compositions with improved stability
CA2581798A1 (en) 2004-10-05 2006-04-13 Petter Lybeck A pharmaceutical formulation comprising crystalline insulin and dissolved insulin
RU2288000C1 (ru) * 2005-04-27 2006-11-27 Институт нефтехимического синтеза им. А.В. Топчиева РАН (ИНХС РАН) Раствор инсулина для перорального введения
EP3677275B1 (de) 2008-10-17 2024-06-12 Sanofi-Aventis Deutschland GmbH Kombination von einem insulin und einem glp-1-agonisten
ES2965209T3 (es) 2009-11-13 2024-04-11 Sanofi Aventis Deutschland Composición farmacéutica que comprende desPro36exendina-4(1-39)-Lys6-NH2 y metionina
PL2498802T3 (pl) 2009-11-13 2015-06-30 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę
JP6199186B2 (ja) 2010-08-30 2017-09-20 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型糖尿病の治療用の医薬の製造のためのave0010の使用
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
TWI608847B (zh) 2011-08-29 2017-12-21 賽諾菲阿凡提斯德意志有限公司 用於控制糖尿病二型病患血糖的醫藥組合物
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
JP2016505601A (ja) * 2012-12-26 2016-02-25 ウォックハート リミテッド 医薬組成物
TWI780236B (zh) 2013-02-04 2022-10-11 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
AU2015205624A1 (en) 2014-01-09 2016-07-14 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
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
CN105899191B (zh) 2014-01-09 2020-06-16 赛诺菲 胰岛素类似物和/或胰岛素衍生物的稳定化不含甘油的药物制剂
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
EP3091964A1 (en) * 2014-01-09 2016-11-16 Sanofi Stabilized pharmaceutical formulations of insulin aspart
ES2949095T3 (es) 2014-12-12 2023-09-25 Sanofi Aventis Deutschland Formulación de relación fija de insulina glargina/lixisenatida
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
JP2023549542A (ja) * 2020-11-16 2023-11-27 ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド 曇点の無い製剤、方法及び予充填複数回投与注入機器

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
DK0705275T3 (da) * 1993-06-21 1999-09-20 Novo Nordisk As AspB28-insulin-krystaller
CA2171424C (en) * 1993-09-17 2002-06-04 Svend Havelund Acylated insulin
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
EP0921812A1 (en) 1999-06-16
HUP9904031A2 (hu) 2000-04-28
DK0921812T3 (da) 2002-02-11
JP2009235075A (ja) 2009-10-15
NO985981L (no) 1998-12-18
RU2182015C2 (ru) 2002-05-10
KR20000022031A (ko) 2000-04-25
CZ395698A3 (cs) 1999-05-12
ES2167751T3 (es) 2002-05-16
IL127366A (en) 2007-07-04
ZA975470B (en) 1997-12-22
BR9709845A (pt) 1999-08-10
UA49890C2 (uk) 2002-10-15
IL127366A0 (en) 1999-10-28
PL189964B1 (pl) 2005-10-31
ES2167751T5 (es) 2012-03-30
ATE208208T1 (de) 2001-11-15
AU3253697A (en) 1998-01-07
JP4404380B2 (ja) 2010-01-27
KR100451778B1 (ko) 2004-11-16
DE69708121T3 (de) 2012-05-16
CN1222083A (zh) 1999-07-07
PT921812E (pt) 2002-04-29
CA2258097C (en) 2011-02-08
HU228094B1 (en) 2012-10-29
AU720484B2 (en) 2000-06-01
WO1997048414A1 (en) 1997-12-24
DE69708121T2 (de) 2002-08-01
CA2258097A1 (en) 1997-12-24
NO324430B1 (no) 2007-10-15
DE69708121D1 (de) 2001-12-13
EP0921812B1 (en) 2001-11-07
CZ297937B6 (cs) 2007-05-02
HUP9904031A3 (en) 2000-10-30
EP0921812B2 (en) 2011-12-21
DK0921812T4 (da) 2012-04-02
PL330763A1 (en) 1999-05-24
NO985981D0 (no) 1998-12-18
CN1120019C (zh) 2003-09-03
JP2000513344A (ja) 2000-10-10

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Legal Events

Date Code Title Description
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/12/2008, OBSERVADAS AS CONDICOES LEGAIS.

B21A Patent or certificate of addition expired [chapter 21.1 patent gazette]

Free format text: PATENTE EXTINTA EM 02.12.2018