JP6525987B2 - インスリングルリジンの安定製剤 - Google Patents

インスリングルリジンの安定製剤 Download PDF

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Publication number
JP6525987B2
JP6525987B2 JP2016524503A JP2016524503A JP6525987B2 JP 6525987 B2 JP6525987 B2 JP 6525987B2 JP 2016524503 A JP2016524503 A JP 2016524503A JP 2016524503 A JP2016524503 A JP 2016524503A JP 6525987 B2 JP6525987 B2 JP 6525987B2
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Prior art keywords
aqueous pharmaceutical
insulin
pharmaceutical formulation
formulation according
type
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Expired - Fee Related
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JP2016524503A
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English (en)
Japanese (ja)
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JP2016539921A5 (enExample
JP2016539921A (ja
Inventor
ペトラ・ロース
トーマス・ゲルマン
ハーラルト・ベルヒトルト
ウルリヒ・ヴェルナー
マティーアス・ガンツ
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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
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Application filed by 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 filed Critical 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
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    • 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

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  • 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)
JP2016524503A 2013-10-25 2014-10-24 インスリングルリジンの安定製剤 Expired - Fee Related JP6525987B2 (ja)

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 (3)

Publication Number Publication Date
JP2016539921A JP2016539921A (ja) 2016-12-22
JP2016539921A5 JP2016539921A5 (enExample) 2017-11-30
JP6525987B2 true JP6525987B2 (ja) 2019-06-05

Family

ID=49552301

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016524503A Expired - Fee Related JP6525987B2 (ja) 2013-10-25 2014-10-24 インスリングルリジンの安定製剤

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
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
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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