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

Info

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
Authority
CN
China
Prior art keywords
aqueous pharmaceutical
pharmaceutical preparations
insulin
diabetes
glulisine
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K38/26Glucagons
    • 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
    • A61K47/06Organic 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/20Organic 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs 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)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
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 (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
JP5694779B2 (ja) 2008-01-09 2015-04-01 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 極度に遅延した時間作用プロファイルを有する新規なインスリン誘導体
LT3228320T (lt) 2008-10-17 2020-03-10 Sanofi-Aventis Deutschland Gmbh Insulino ir glp-1 agonisto derinys
PL2498802T3 (pl) 2009-11-13 2015-06-30 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę
EP2498801B1 (de) 2009-11-13 2018-01-24 Sanofi-Aventis Deutschland GmbH HARMAZEUTISCHE ZUSAMMENSETZUNG UMFASSEND desPro36Exendin-4(1-39)-Lys6-NH2 UND METHIONIN
SI2611458T1 (sl) 2010-08-30 2017-01-31 Sanofi-Aventis Deutschland Gmbh Uporaba AVE0010 za izdelavo zdravila za zdravljenje sladkorne bolezni tipa 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
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
CA2970200A1 (en) 2014-12-12 2016-06-16 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
IL277721B2 (en) 2018-04-04 2024-03-01 Arecor Ltd 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)

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
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
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
EP2308473A4 (en) * 2008-07-01 2013-01-09 Nitto Denko Corp PHARMACEUTICAL COMPOSITION CONTAINING MICROPARTICLES WITH SURFACE COATING
MA33467B1 (fr) * 2009-07-31 2012-07-03 Sanofi Aventis Deutschland Promédicaments comprenant un conjugué insuline-lieur
PL2498802T3 (pl) * 2009-11-13 2015-06-30 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę
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
AU2015205620A1 (en) * 2014-01-09 2016-07-14 Sanofi Stabilized pharmaceutical formulations of insulin 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
KR20160074562A (ko) 2016-06-28
IL245109A0 (en) 2016-06-30
RU2016119746A3 (enExample) 2018-06-04
AU2014338863A1 (en) 2016-05-19
CA2928320A1 (en) 2015-04-30
SG10201803430SA (en) 2018-06-28
TW201605489A (zh) 2016-02-16
HK1225613A1 (zh) 2017-09-15
US20180036411A1 (en) 2018-02-08
PH12016500720A1 (en) 2016-05-30
EP3060240A1 (en) 2016-08-31
AR098168A1 (es) 2016-05-04
SG11201602939QA (en) 2016-05-30
CL2016000950A1 (es) 2016-11-04
RU2691059C2 (ru) 2019-06-10
US20150119323A1 (en) 2015-04-30
MX2016005395A (es) 2017-02-28
WO2015059302A1 (en) 2015-04-30
RU2016119746A (ru) 2017-11-30
JP2016539921A (ja) 2016-12-22
BR112016008736A2 (pt) 2017-09-12

Similar Documents

Publication Publication Date Title
CN105705161A (zh) 赖谷胰岛素的稳定制剂
KR100987311B1 (ko) 아연을 전혀 포함하지 않거나 소량의 아연만을 포함한 개선된 안정성을 가지는 인슐린 제형
TWI643637B (zh) 長效胰促泌素肽接合物之液體製劑
JP5675799B2 (ja) 遅効性インスリン製剤
KR102482664B1 (ko) 신규한 제제
JP2023166014A (ja) コラーゲン7組成物及びそれを用いる方法
EP3419649B1 (en) Stable pharmaceutical compositions comprising insulin glargine and insulin aspart and methods of preparation thereof
JP6920471B2 (ja) 迅速に作用するインスリン組成物
HK1061521B (en) Insulin preparations, which do not contain any zinc or only a small quantity of zinc and which have an improved stability

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20160622