TW201605489A - 賴谷胰島素(insulin glulisine)的穩定調配物 - Google Patents

賴谷胰島素(insulin glulisine)的穩定調配物 Download PDF

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Publication number
TW201605489A
TW201605489A TW103136573A TW103136573A TW201605489A TW 201605489 A TW201605489 A TW 201605489A TW 103136573 A TW103136573 A TW 103136573A TW 103136573 A TW103136573 A TW 103136573A TW 201605489 A TW201605489 A TW 201605489A
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TW
Taiwan
Prior art keywords
insulin
pharmaceutical formulation
aqueous pharmaceutical
formulation according
diabetes
Prior art date
Application number
TW103136573A
Other languages
English (en)
Chinese (zh)
Inventor
彼特羅 路斯
湯瑪士 喬曼
哈羅德 博區特德
優瑞區 威尼爾
馬提亞斯 蓋茲
Original Assignee
賽諾菲公司
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Publication date
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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=TW201605489(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 賽諾菲公司 filed Critical 賽諾菲公司
Publication of TW201605489A publication Critical patent/TW201605489A/zh

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    • 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
    • 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
    • A61K9/08Solutions
    • 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)
TW103136573A 2013-10-25 2014-10-23 賴谷胰島素(insulin glulisine)的穩定調配物 TW201605489A (zh)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP13306475 2013-10-25

Publications (1)

Publication Number Publication Date
TW201605489A true TW201605489A (zh) 2016-02-16

Family

ID=49552301

Family Applications (1)

Application Number Title Priority Date Filing Date
TW103136573A TW201605489A (zh) 2013-10-25 2014-10-23 賴谷胰島素(insulin glulisine)的穩定調配物

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)

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
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.
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
EP2308473A4 (en) * 2008-07-01 2013-01-09 Nitto Denko Corp PHARMACEUTICAL COMPOSITION CONTAINING MICROPARTICLES WITH SURFACE COATING
EP3202394A1 (de) * 2009-07-06 2017-08-09 Sanofi-Aventis Deutschland GmbH Wässrige insulinzubereitungen enthaltend methionin
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
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
CA2839511C (en) * 2011-06-17 2018-07-31 Halozyme, Inc. Stable formulations of a hyaluronan-degrading enzyme
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

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
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
CN105705161A (zh) 2016-06-22
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

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