EA200200684A1 - Полипептидные композиции, обладающие повышенной стабильностью - Google Patents

Полипептидные композиции, обладающие повышенной стабильностью

Info

Publication number
EA200200684A1
EA200200684A1 EA200200684A EA200200684A EA200200684A1 EA 200200684 A1 EA200200684 A1 EA 200200684A1 EA 200200684 A EA200200684 A EA 200200684A EA 200200684 A EA200200684 A EA 200200684A EA 200200684 A1 EA200200684 A1 EA 200200684A1
Authority
EA
Eurasian Patent Office
Prior art keywords
compositions
glycerin
polypeptide
chemical stability
polypeptid
Prior art date
Application number
EA200200684A
Other languages
English (en)
Other versions
EA004631B1 (ru
Inventor
Майкл Розарио Дефелиппис
Майкл Аллен Доббинс
Элби Дэвид Шаркнас
Алекс Марк Прокай
Джозеф Винсент мл. Ринелла
Original Assignee
Эли Лилли Энд Компани
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=27341882&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA200200684(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from JP37720899A external-priority patent/JP2001181203A/ja
Application filed by Эли Лилли Энд Компани filed Critical Эли Лилли Энд Компани
Publication of EA200200684A1 publication Critical patent/EA200200684A1/ru
Publication of EA004631B1 publication Critical patent/EA004631B1/ru

Links

Classifications

    • 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
    • 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
    • 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
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Cosmetics (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicinal Preparation (AREA)

Abstract

В настоящем изобретении предложены средства для повышения химической стабильности водных фармацевтических композиций для парентерального использования, включающих полипептид и глицерин. Реакционно-способные альдегиды идентифицируют в коммерческих глицеринах, и предложены способы снижения их содержания. Предложены удобные способы анализа реакционно-способных альдегидов в глицерине и продемонстрирована четкая линейная зависимость между содержанием в глицерине реакционно-способных альдегидов и химической стабильностью композиций, включающих полипептид и глицерин. Настоящее изобретение включает водные композиции, включающие полипептид и глицерин и обладающие повышенной химической стабильностью по сравнению с известными ранее композициями.Отчет о международном поиске был опубликован 2002.01.10.
EA200200684A 1999-12-16 2000-12-05 Полипептидные композиции, обладающие повышенной стабильностью EA004631B1 (ru)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US17113599P 1999-12-16 1999-12-16
JP37720899A JP2001181203A (ja) 1999-12-16 1999-12-28 安定性が改良されたポリペプチド組成物
US18103000P 2000-02-08 2000-02-08
PCT/US2000/032421 WO2001043762A2 (en) 1999-12-16 2000-12-05 Polypeptide compositions with improved stability

Publications (2)

Publication Number Publication Date
EA200200684A1 true EA200200684A1 (ru) 2003-02-27
EA004631B1 EA004631B1 (ru) 2004-06-24

Family

ID=27341882

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200200684A EA004631B1 (ru) 1999-12-16 2000-12-05 Полипептидные композиции, обладающие повышенной стабильностью

Country Status (15)

Country Link
EP (1) EP1242121B1 (ru)
JP (1) JP2003523972A (ru)
CN (1) CN1409640A (ru)
AT (1) ATE288765T1 (ru)
AU (1) AU777570B2 (ru)
BR (1) BR0016334A (ru)
CA (1) CA2394213A1 (ru)
DE (2) DE60018105T2 (ru)
DK (1) DK200000375U1 (ru)
EA (1) EA004631B1 (ru)
ES (1) ES2236010T3 (ru)
IL (1) IL150129A0 (ru)
PL (1) PL355378A1 (ru)
PT (1) PT1242121E (ru)
WO (1) WO2001043762A2 (ru)

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1412384B1 (en) 2001-06-28 2007-12-26 Novo Nordisk A/S Stable formulation of modified glp-1
DE10227232A1 (de) 2002-06-18 2004-01-15 Aventis Pharma Deutschland Gmbh Saure Insulinzubereitungen mit verbesserter Stabilität
US20040121009A1 (en) * 2002-10-17 2004-06-24 Alkermes Controlled Therapeutics, Inc. Method of modifying the release profile of sustained release compositions
CA2502825A1 (en) * 2002-10-22 2004-05-06 Dainippon Pharmaceutical Co., Ltd. Stabilized composition
EP2292254A3 (en) 2003-06-03 2011-12-14 Novo Nordisk A/S Stabilized pharmaceutical peptide compositions
JP2007524592A (ja) 2003-06-03 2007-08-30 ノボ・ノルデイスク・エー／エス 安定化された薬学的ペプチド組成物
CA2545034C (en) 2003-11-20 2013-03-05 Novo Nordisk A/S Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
EP1687248B1 (en) 2003-11-20 2011-06-01 SOLVAY (Société Anonyme) Process for producing dichloropropanol from glycerol and a chlorinated agent and in the presence of a catalyst selected from adipic and glutaric acid
PL1789434T3 (pl) 2004-08-31 2014-07-31 Novo Nordisk As Zastosowanie tris(hydroksymetylo)aminometanu do stabilizacji peptydów, polipeptydów i białek
EP1817048B1 (en) 2004-11-12 2014-02-12 Novo Nordisk A/S Stable formulations of insulinoptropic peptides
DE502007003700D1 (de) * 2006-07-27 2010-06-24 Cognis Ip Man Gmbh Verfahren zur Herstellung von Glycerin
TWI478875B (zh) 2008-01-31 2015-04-01 Solvay 使水性組成物中之有機物質降解之方法
AU2009226910B2 (en) 2008-03-18 2014-02-06 Novo Nordisk A/S Protease stabilized, acylated insulin analogues
FR2935968B1 (fr) 2008-09-12 2010-09-10 Solvay Procede pour la purification de chlorure d'hydrogene
KR101939557B1 (ko) 2008-10-17 2019-01-17 사노피-아벤티스 도이칠란트 게엠베하 인슐린과 ｇｌｐ－1 효능제의 병용물
CN107308442B (zh) 2009-11-13 2022-10-18 赛诺菲-安万特德国有限公司 包含glp-1激动剂、胰岛素和甲硫氨酸的药物组合物
PT3345593T (pt) 2009-11-13 2023-11-27 Sanofi Aventis Deutschland Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina
JP2011195557A (ja) * 2010-02-24 2011-10-06 Kyorin Pharmaceutical Co Ltd 糖アルコールの選択方法
LT2611458T (lt) 2010-08-30 2016-12-27 Sanofi-Aventis Deutschland Gmbh Ave0010 panaudojimas gaminant vaistą, skirtą 2 tipo cukrinio diabeto gydymui
DK2433651T3 (da) 2010-09-03 2013-04-08 Aug Hedinger Gmbh & Co Kg Fremgangsmåde til bestemmelse af aldehyder og ketoner i glycerin
EP2621911A1 (en) 2010-09-30 2013-08-07 Solvay Sa Derivative of epichlorohydrin of natural origin
US9097692B2 (en) 2010-10-01 2015-08-04 Aug. Hedinger Gmbh & Co. Kg Method for quantitatively determining impurities in glycerin
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
MX370264B (es) 2011-08-29 2019-12-09 Sanofi Aventis Deutschland Combinacion farmaceutica para uso en el control glucemico en pacientes con diabetes de tipo 2.
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
AU2013247047A1 (en) 2012-04-11 2014-10-23 Novo Nordisk A/S Insulin formulations
SI3229828T1 (sl) 2014-12-12 2023-06-30 Sanofi-Aventis Deutschland Gmbh Formulacija s fiksnim razmerjem inzulin glargin/liksisenatid
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
BR112019011761A2 (pt) 2016-12-16 2019-11-05 Novo Nordisk As composições farmacêuticas contendo insulina
PL3474820T3 (pl) 2017-08-24 2024-05-13 Novo Nordisk A/S Kompozycje glp-1 i ich zastosowania
US20230018324A1 (en) * 2019-12-06 2023-01-19 Dr. Mary Morris & Associates, Llc Methods and compositions for the treatment and prevention of type 1 diabetes
EP4106724A1 (en) 2020-02-18 2022-12-28 Novo Nordisk A/S Glp-1 compositions and uses thereof
CA3193994A1 (en) * 2020-10-08 2022-04-14 Mary S. MORRIS Methods and compositions for the treatment and prevention of type 1 diabetes
WO2024081659A1 (en) * 2022-10-13 2024-04-18 Archer Daniels Midland Company Purification of glycerin as excipient in parenteral pharmaceutical applications

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL189964B1 (pl) * 1996-06-20 2005-10-31 Novo Nordisk As Wodny preparat insuliny, środek farmaceutyczny dopodawania pozajelitowego oraz sposób poprawiania chemicznej stabilności preparatów insuliny

Also Published As

Publication number Publication date
WO2001043762A2 (en) 2001-06-21
AU777570B2 (en) 2004-10-21
EP1242121B1 (en) 2005-02-09
CA2394213A1 (en) 2001-06-21
JP2003523972A (ja) 2003-08-12
PT1242121E (pt) 2005-05-31
EA004631B1 (ru) 2004-06-24
PL355378A1 (en) 2004-04-19
DE60018105D1 (de) 2005-03-17
DE60018105T2 (de) 2005-12-29
AU2049301A (en) 2001-06-25
EP1242121A2 (en) 2002-09-25
CN1409640A (zh) 2003-04-09
ATE288765T1 (de) 2005-02-15
IL150129A0 (en) 2002-12-01
DK200000375U1 (da) 2001-03-16
ES2236010T3 (es) 2005-07-16
BR0016334A (pt) 2002-09-10
WO2001043762A3 (en) 2002-01-10
DE20021079U1 (de) 2001-03-22

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Legal Events

Date Code Title Description
MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM

MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): RU