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)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (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 (26)

* 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
US6489292B1 (en) 1998-11-18 2002-12-03 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
EP1131089B1 (en) * 1998-11-18 2004-02-18 Novo Nordisk A/S Stable aqueous insulin preparations without phenol and cresol
WO2000043034A2 (en) * 1999-01-26 2000-07-27 Eli Lilly And Company Monodisperse hexameric acylated insulin analog formulations
EP1165063A1 (en) * 1999-04-05 2002-01-02 Verteletsky, Pavel Vasilievich Use of succinic acid or salts thereof for the treatment of diabetes mellitus and wound healing
US7022674B2 (en) 1999-12-16 2006-04-04 Eli Lilly And Company Polypeptide compositions with improved stability
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
DK2918286T3 (da) 2004-10-05 2020-03-30 Novo Nordisk As En farmaceutisk formulering
DK2349324T3 (en) 2008-10-17 2017-12-11 Sanofi Aventis Deutschland COMBINATION OF AN INSULIN AND A GLP-1 AGONIST
PT2498802E (pt) 2009-11-13 2015-04-13 Sanofi Aventis Deutschland Composição farmacêutica que compreende um agonista de glp-1, uma insulina e metionina
PE20121316A1 (es) 2009-11-13 2012-10-05 Sanofi Aventis Deutschland Composicion farmaceutica que comprende un agonista de glp-1 y metionina
HUE031181T2 (en) 2010-08-30 2017-06-28 Sanofi Aventis Deutschland Use of AVE0010 for the manufacture of a medicament for the treatment of type 2 diabetes
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
EP2750699B1 (en) 2011-08-29 2015-07-22 Sanofi-Aventis Deutschland GmbH Pharmaceutical combination for use in glycemic control in diabetes type 2 patients
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
US20150246129A1 (en) * 2012-12-26 2015-09-03 Wockhardt Limited Pharmaceutical composition
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
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
RU2016132340A (ru) 2014-01-09 2018-02-14 Санофи Стабилизированные фармацевтические составы на основе инсулина аспарта
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
MX2016008979A (es) 2014-01-09 2016-10-04 Sanofi Sa Formulaciones farmaceuticas estabilizadas de analogos de insulina y/o derivados de insulina.
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
FI3229828T3 (fi) 2014-12-12 2023-05-29 Sanofi Aventis Deutschland Glargiini-insuliinin/liksisenatidin vakiosuhteinen formulaatio
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

Family Cites Families (11)

* 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.
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
NZ232375A (en) * 1989-02-09 1992-04-28 Lilly Co Eli Insulin analogues modified at b29
ATE176482T1 (de) * 1993-06-21 1999-02-15 Novo Nordisk As Asp-b28-insulinkristalle
DK0792290T3 (da) * 1993-09-17 2001-10-01 Novo Nordisk As Acyleret 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
DE69708121T3 (de) 2012-05-16
DE69708121D1 (de) 2001-12-13
ES2167751T5 (es) 2012-03-30
HUP9904031A3 (en) 2000-10-30
EP0921812B1 (en) 2001-11-07
CZ395698A3 (cs) 1999-05-12
WO1997048414A1 (en) 1997-12-24
KR20000022031A (ko) 2000-04-25
PL189964B1 (pl) 2005-10-31
CZ297937B6 (cs) 2007-05-02
DK0921812T3 (da) 2002-02-11
JP4404380B2 (ja) 2010-01-27
PL330763A1 (en) 1999-05-24
PT921812E (pt) 2002-04-29
BR9709845B1 (pt) 2008-11-18
EP0921812A1 (en) 1999-06-16
CA2258097C (en) 2011-02-08
ZA975470B (en) 1997-12-22
HUP9904031A2 (hu) 2000-04-28
CN1222083A (zh) 1999-07-07
AU720484B2 (en) 2000-06-01
RU2182015C2 (ru) 2002-05-10
AU3253697A (en) 1998-01-07
ATE208208T1 (de) 2001-11-15
CA2258097A1 (en) 1997-12-24
JP2009235075A (ja) 2009-10-15
NO985981D0 (no) 1998-12-18
ES2167751T3 (es) 2002-05-16
NO985981L (no) 1998-12-18
UA49890C2 (uk) 2002-10-15
EP0921812B2 (en) 2011-12-21
IL127366A (en) 2007-07-04
NO324430B1 (no) 2007-10-15
KR100451778B1 (ko) 2004-11-16
JP2000513344A (ja) 2000-10-10
DE69708121T2 (de) 2002-08-01
CN1120019C (zh) 2003-09-03
DK0921812T4 (da) 2012-04-02
IL127366A0 (en) 1999-10-28
HU228094B1 (en) 2012-10-29

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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