CN105705161A - 赖谷胰岛素的稳定制剂 - Google Patents

赖谷胰岛素的稳定制剂 Download PDF

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Publication number
CN105705161A
CN105705161A CN201480058603.5A CN201480058603A CN105705161A CN 105705161 A CN105705161 A CN 105705161A CN 201480058603 A CN201480058603 A CN 201480058603A CN 105705161 A CN105705161 A CN 105705161A
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CN
China
Prior art keywords
aqueous pharmaceutical
pharmaceutical formulation
insulin
formulation according
diabetes
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201480058603.5A
Other languages
English (en)
Chinese (zh)
Inventor
P·卢斯
T·格尔曼
H·伯克托尔德
U·沃纳
M·甘兹
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
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=CN105705161(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Publication of CN105705161A publication Critical patent/CN105705161A/zh
Pending legal-status Critical Current

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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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CN201480058603.5A 2013-10-25 2014-10-24 赖谷胰岛素的稳定制剂 Pending CN105705161A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13306475.8 2013-10-25
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
CN105705161A true CN105705161A (zh) 2016-06-22

Family

ID=49552301

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201480058603.5A Pending CN105705161A (zh) 2013-10-25 2014-10-24 赖谷胰岛素的稳定制剂

Country Status (18)

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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY152979A (en) 2008-01-09 2014-12-15 Sanofi Aventis Deutschland Novel insulin derivatives having an extremely delayed time-action profile
RS59913B1 (sr) 2008-10-17 2020-03-31 Sanofi Aventis Deutschland Kombinacija insulina i glp-1-agonista
CN102596175A (zh) 2009-07-06 2012-07-18 赛诺菲-安万特德国有限公司 含有甲硫氨酸的水性胰岛素制备物
MY180661A (en) 2009-11-13 2020-12-04 Sanofi Aventis Deutschland Pharmaceutical composition comprising a glp-1 agonist, an insulin and methionine
PT3345593T (pt) 2009-11-13 2023-11-27 Sanofi Aventis Deutschland Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina
PL2611458T3 (pl) 2010-08-30 2017-02-28 Sanofi-Aventis Deutschland Gmbh Zastosowanie AVE0010 do produkcji leku do leczenia cukrzycy typu 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
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
EP3229828B1 (en) 2014-12-12 2023-04-05 Sanofi-Aventis Deutschland GmbH Insulin glargine/lixisenatide fixed ratio formulation
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
JP2019529506A (ja) 2016-09-29 2019-10-17 アレコル リミテッド 新規の製剤
US12357562B2 (en) 2018-04-04 2025-07-15 Arecor Limited Injection pen 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)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1498113A (zh) * 2001-03-23 2004-05-19 ������ҽҩ�¹����޹�˾ 稳定性提高的无锌或低锌胰岛素制剂
WO2011085393A1 (en) * 2010-01-11 2011-07-14 Genecopoeia, Inc. Stable insulin formulations and methods of making and using thereof
CN102596175A (zh) * 2009-07-06 2012-07-18 赛诺菲-安万特德国有限公司 含有甲硫氨酸的水性胰岛素制备物
WO2012174478A2 (en) * 2011-06-17 2012-12-20 Halozyme, Inc. Stable formulations of a hyaluronan-degrading enzyme

Family Cites Families (11)

* 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
US5948751A (en) 1996-06-20 1999-09-07 Novo Nordisk A/S X14-mannitol
US5866538A (en) 1996-06-20 1999-02-02 Novo Nordisk A/S Insulin preparations containing NaCl
AR012894A1 (es) 1997-06-13 2000-11-22 Lilly Co Eli Formulacion de insulina en solucion estable, su uso para preparar un medicamento y proceso para la preparacion de la misma.
TWI394580B (zh) * 2008-04-28 2013-05-01 Halozyme Inc 超快起作用胰島素組成物
RU2508093C2 (ru) * 2008-07-01 2014-02-27 Нитто Денко Корпорейшн Фармацевтическая композиция, содержащая микрочастицы с поверхностным покрытием
US9138462B2 (en) * 2009-07-31 2015-09-22 Sanofi-Aventis Deutschland Gmbh Prodrugs comprising an insulin linker conjugate
MY180661A (en) * 2009-11-13 2020-12-04 Sanofi Aventis Deutschland Pharmaceutical composition comprising a glp-1 agonist, an insulin and methionine
US20130011378A1 (en) * 2011-06-17 2013-01-10 Tzung-Horng Yang Stable formulations of a hyaluronan-degrading enzyme
CN104902922B (zh) * 2012-11-13 2017-12-12 阿道恰公司 包含经取代阴离子化合物的速效胰岛素制剂
BR112016015851A2 (pt) * 2014-01-09 2017-08-08 Sanofi Sa Formulações farmacêuticas estabilizadas de insulina aspart

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1498113A (zh) * 2001-03-23 2004-05-19 ������ҽҩ�¹����޹�˾ 稳定性提高的无锌或低锌胰岛素制剂
CN102596175A (zh) * 2009-07-06 2012-07-18 赛诺菲-安万特德国有限公司 含有甲硫氨酸的水性胰岛素制备物
WO2011085393A1 (en) * 2010-01-11 2011-07-14 Genecopoeia, Inc. Stable insulin formulations and methods of making and using thereof
WO2012174478A2 (en) * 2011-06-17 2012-12-20 Halozyme, Inc. Stable formulations of a hyaluronan-degrading enzyme

Also Published As

Publication number Publication date
JP6525987B2 (ja) 2019-06-05
HK1225613A1 (zh) 2017-09-15
IL245109A0 (en) 2016-06-30
WO2015059302A1 (en) 2015-04-30
AR098168A1 (es) 2016-05-04
PH12016500720A1 (en) 2016-05-30
RU2016119746A3 (https=) 2018-06-04
MX2016005395A (es) 2017-02-28
KR20160074562A (ko) 2016-06-28
SG10201803430SA (en) 2018-06-28
SG11201602939QA (en) 2016-05-30
JP2016539921A (ja) 2016-12-22
RU2016119746A (ru) 2017-11-30
EP3060240A1 (en) 2016-08-31
AU2014338863A1 (en) 2016-05-19
CA2928320A1 (en) 2015-04-30
RU2691059C2 (ru) 2019-06-10
US20180036411A1 (en) 2018-02-08
CL2016000950A1 (es) 2016-11-04
TW201605489A (zh) 2016-02-16
BR112016008736A2 (pt) 2017-09-12
US20150119323A1 (en) 2015-04-30

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Application publication date: 20160622