BR112016008736A2 - formulação estável de insulina glulisina - Google Patents

formulação estável de insulina glulisina

Info

Publication number
BR112016008736A2
BR112016008736A2 BR112016008736A BR112016008736A BR112016008736A2 BR 112016008736 A2 BR112016008736 A2 BR 112016008736A2 BR 112016008736 A BR112016008736 A BR 112016008736A BR 112016008736 A BR112016008736 A BR 112016008736A BR 112016008736 A2 BR112016008736 A2 BR 112016008736A2
Authority
BR
Brazil
Prior art keywords
insulin glulisine
stable formulation
glulisine
insulin
formulation
Prior art date
Application number
BR112016008736A
Other languages
English (en)
Portuguese (pt)
Inventor
Berchtold Harald
Ganz Matthias
Loos Petra
Gehrmann Thomas
Werner Ulrich
Original Assignee
Sanofi Sa
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=49552301&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016008736(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Sa filed Critical Sanofi Sa
Publication of BR112016008736A2 publication Critical patent/BR112016008736A2/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K38/26—Glucagons
    • 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
    • A61K47/06—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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
BR112016008736A 2013-10-25 2014-10-24 formulação estável de insulina glulisina BR112016008736A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13306475 2013-10-25
PCT/EP2014/072915 WO2015059302A1 (en) 2013-10-25 2014-10-24 Stable formulation of insulin glulisine

Publications (1)

Publication Number Publication Date
BR112016008736A2 true BR112016008736A2 (pt) 2017-09-12

Family

ID=49552301

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016008736A BR112016008736A2 (pt) 2013-10-25 2014-10-24 formulação estável de insulina glulisina

Country Status (18)

Country Link
US (2) US20150119323A1 (enExample)
EP (1) EP3060240A1 (enExample)
JP (1) JP6525987B2 (enExample)
KR (1) KR20160074562A (enExample)
CN (1) CN105705161A (enExample)
AR (1) AR098168A1 (enExample)
AU (1) AU2014338863A1 (enExample)
BR (1) BR112016008736A2 (enExample)
CA (1) CA2928320A1 (enExample)
CL (1) CL2016000950A1 (enExample)
HK (1) HK1225613A1 (enExample)
IL (1) IL245109A0 (enExample)
MX (1) MX2016005395A (enExample)
PH (1) PH12016500720A1 (enExample)
RU (1) RU2691059C2 (enExample)
SG (2) SG11201602939QA (enExample)
TW (1) TW201605489A (enExample)
WO (1) WO2015059302A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ586590A (en) 2008-01-09 2012-06-29 Sanofi Aventis Deutschland Insulin analogues or derivatives having an extremely delayed time-action profile
LT2349324T (lt) 2008-10-17 2017-12-27 Sanofi-Aventis Deutschland Gmbh Insulino ir glp-1 agonisto derinys
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
JP5832439B2 (ja) 2009-11-13 2015-12-16 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 Ｇｌｐ−１アゴニスト、インスリン及びメチオニンを含む薬学的組成物
CN103179978A (zh) 2010-08-30 2013-06-26 赛诺菲-安万特德国有限公司 Ave0010用于制造供治疗2型糖尿病用的药物的用途
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
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
MA41138B1 (fr) 2014-12-12 2023-07-31 Sanofi Aventis Deutschland Formulation à rapport fixe d'insuline glargine/lixisenatide
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
WO2019193353A1 (en) 2018-04-04 2019-10-10 Arecor Limited Medical infusion pump system for the delivery of an insulin compound
FR3083700B1 (fr) * 2018-07-13 2021-03-12 Adocia Formulation thermostable d'insuline humaine a21g
AR131148A1 (es) * 2022-11-26 2025-02-19 Obshchestvo S Ogranichennoy Otvetstvennostyu «Geropharm» Composiciones de insulina de acción rápida (variantes de las mismas)

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5474978A (en) 1994-06-16 1995-12-12 Eli Lilly And Company Insulin analog formulations
US5866538A (en) 1996-06-20 1999-02-02 Novo Nordisk A/S Insulin preparations containing NaCl
US5948751A (en) 1996-06-20 1999-09-07 Novo Nordisk A/S X14-mannitol
CO4750643A1 (es) 1997-06-13 1999-03-31 Lilly Co Eli Formulacion estable de la insulina que contiene l-arginina y protamina
DE10114178A1 (de) * 2001-03-23 2002-10-10 Aventis Pharma Gmbh Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität
TWI394580B (zh) * 2008-04-28 2013-05-01 Halozyme Inc 超快起作用胰島素組成物
JP5841708B2 (ja) * 2008-07-01 2016-01-13 日東電工株式会社 表面被覆微粒子の医薬組成物
KR101853606B1 (ko) * 2009-07-06 2018-05-03 사노피-아벤티스 도이칠란트 게엠베하 메티오닌을 함유하는 수성 인슐린 제제
KR20120089843A (ko) * 2009-07-31 2012-08-14 사노피-아벤티스 도이칠란트 게엠베하 인슐린 링커 접합체를 포함한 프로드럭
JP5832439B2 (ja) * 2009-11-13 2015-12-16 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 Ｇｌｐ−１アゴニスト、インスリン及びメチオニンを含む薬学的組成物
CN101912600B (zh) * 2010-01-11 2014-01-29 杨国汉 改善胰岛素在溶液中稳定性的方法
BR112013032396A2 (pt) * 2011-06-17 2016-11-22 Halozyme Inc formulações estáveis de aplicações relacionadas à enzima de degradação de ácido hialurônico
US9993529B2 (en) * 2011-06-17 2018-06-12 Halozyme, Inc. Stable formulations of a hyaluronan-degrading enzyme
EP2919804B1 (fr) * 2012-11-13 2018-01-31 Adocia Formulation à action rapide d'insuline comprenant un composé anionique substitué
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

Also Published As

Publication number Publication date
AR098168A1 (es) 2016-05-04
JP2016539921A (ja) 2016-12-22
TW201605489A (zh) 2016-02-16
EP3060240A1 (en) 2016-08-31
WO2015059302A1 (en) 2015-04-30
KR20160074562A (ko) 2016-06-28
RU2016119746A3 (enExample) 2018-06-04
PH12016500720A1 (en) 2016-05-30
US20180036411A1 (en) 2018-02-08
HK1225613A1 (zh) 2017-09-15
RU2016119746A (ru) 2017-11-30
JP6525987B2 (ja) 2019-06-05
US20150119323A1 (en) 2015-04-30
CL2016000950A1 (es) 2016-11-04
MX2016005395A (es) 2017-02-28
CN105705161A (zh) 2016-06-22
AU2014338863A1 (en) 2016-05-19
IL245109A0 (en) 2016-06-30
SG10201803430SA (en) 2018-06-28
RU2691059C2 (ru) 2019-06-10
CA2928320A1 (en) 2015-04-30
SG11201602939QA (en) 2016-05-30

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements
B350 Update of information on the portal [chapter 15.35 patent gazette]