BRPI0519393A2 - formulaÇço em soluÇço estÁvel - Google Patents

formulaÇço em soluÇço estÁvel

Info

Publication number
BRPI0519393A2
BRPI0519393A2 BRPI0519393-1A BRPI0519393A BRPI0519393A2 BR PI0519393 A2 BRPI0519393 A2 BR PI0519393A2 BR PI0519393 A BRPI0519393 A BR PI0519393A BR PI0519393 A2 BRPI0519393 A2 BR PI0519393A2
Authority
BR
Brazil
Prior art keywords
glp
solution formulation
stable solution
fusion
inhibiting
Prior art date
Application number
BRPI0519393-1A
Other languages
English (en)
Inventor
Wolfgang Glaesner
Rohn Lee Millican
Original Assignee
Lilly Co Eli
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=36123207&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0519393(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lilly Co Eli filed Critical Lilly Co Eli
Publication of BRPI0519393A2 publication Critical patent/BRPI0519393A2/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

FORMULAÇçO EM SOLUÇçO ESTÁVEL. A invenção fornece uma formulação em solução estável compreendendo uma fusão de GLP- 1 -Fc em um pH entre cerca de pH 6 e cerca de pH 8,5, análogos fundidos em derivados específicos de IgG4-Fc. Estas formulações proporcionam estabilidade química inesperada e consideravelmente maior do que quando comparadas às fusões de GLP- 1 -Fc em um pH fora das faixas descritas. As formulações compreendendo uma fusão de GLP- 1 -Fc são úteis no tratamento do diabete, da obesidade, da síndrome de intestino irritável e de outras condições que devam ser beneficiadas pela redução da glicose plasmática, inibindo a motilidade gástrica e/ou intestinal e inibindo o esvaziamento gástrico e/ou intestinal, ou inibindo a ingestão de alimentos.
BRPI0519393-1A 2004-12-22 2005-12-15 formulaÇço em soluÇço estÁvel BRPI0519393A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US64169004P 2004-12-22 2004-12-22
PCT/US2005/045376 WO2006068910A1 (en) 2004-12-22 2005-12-15 Glp-1 analog fusion protein formulations

Publications (1)

Publication Number Publication Date
BRPI0519393A2 true BRPI0519393A2 (pt) 2009-01-20

Family

ID=36123207

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0519393-1A BRPI0519393A2 (pt) 2004-12-22 2005-12-15 formulaÇço em soluÇço estÁvel

Country Status (22)

Country Link
US (1) US20090232807A1 (pt)
EP (2) EP2168982A1 (pt)
JP (1) JP2008525452A (pt)
KR (1) KR100879662B1 (pt)
CN (1) CN101044162B (pt)
AT (1) ATE435235T1 (pt)
AU (1) AU2005319432A1 (pt)
BR (1) BRPI0519393A2 (pt)
CA (1) CA2589647A1 (pt)
CY (1) CY1109269T1 (pt)
DE (1) DE602005015257D1 (pt)
DK (1) DK1831252T3 (pt)
EA (1) EA011166B1 (pt)
ES (1) ES2326906T3 (pt)
IL (1) IL183285A0 (pt)
MX (1) MX2007007565A (pt)
NO (1) NO20073372L (pt)
PL (1) PL1831252T3 (pt)
PT (1) PT1831252E (pt)
SI (1) SI1831252T1 (pt)
UA (1) UA87009C2 (pt)
WO (1) WO2006068910A1 (pt)

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KR100888022B1 (ko) * 2006-12-21 2009-03-09 재단법인 목암생명공학연구소 면역글로불린 Ｆｃ와 인간 아포리포단백질（ａ）크링글절편의 융합단백질 ＬＫ8­Ｆｃ
JP2008169195A (ja) * 2007-01-05 2008-07-24 Hanmi Pharmaceutical Co Ltd キャリア物質を用いたインスリン分泌ペプチド薬物結合体
CN101730523A (zh) * 2007-07-10 2010-06-09 伊莱利利公司 GLP-1-Fc融合蛋白质制剂
EP2031064A1 (de) * 2007-08-29 2009-03-04 Boehringer Ingelheim Pharma GmbH & Co. KG Verfahren zur Steigerung von Proteintitern
EP2435061A4 (en) 2009-05-28 2013-03-27 Amylin Pharmaceuticals Inc DAMPING GLP-1 RECEPTOR AGONIST COMPOUNDS
EP2496249B1 (en) 2009-11-03 2016-03-09 Amylin Pharmaceuticals, LLC Glp-1 receptor agonist for use in treating obstructive sleep apnea
WO2011143788A1 (en) * 2010-05-17 2011-11-24 Zhejiang Beta Pharma Inc. Novel glucagon like peptide analogs, composition, and method of use
CN102533655A (zh) * 2010-12-21 2012-07-04 青岛黄海制药有限责任公司 高效表达人源重组蛋白GLP1/Fc的CHO-S细胞株及其建立方法
JP2014504588A (ja) 2010-12-22 2014-02-24 アミリン・ファーマシューティカルズ，リミテッド・ライアビリティ・カンパニー 膵島細胞移植のためのｇｌｐ−１受容体アゴニスト
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR094821A1 (es) 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
US10441665B2 (en) 2012-07-25 2019-10-15 Hanmi Pharm. Co., Ltd. Liquid formulation of long acting insulinotropic peptide conjugate
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
HK1211232A1 (en) 2012-12-21 2016-05-20 Sanofi Exendin-4 derivatives as dual glp1/gip or trigonal glp1/gip/glucagon agonists
CN104173275A (zh) * 2013-05-21 2014-12-03 深圳翰宇药业股份有限公司 度拉鲁肽注射剂及其制备方法
CN104371019B (zh) 2013-08-13 2019-09-10 鸿运华宁（杭州）生物医药有限公司 一种能与glp-1r特异性结合的抗体及其与glp-1的融合蛋白质
WO2015086733A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/glucagon receptor agonists
EP3080152A1 (en) 2013-12-13 2016-10-19 Sanofi Non-acylated exendin-4 peptide analogues
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201609799A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重ｇｌｐ－１／ｇｉｐ受體促效劑
AU2015242657B2 (en) * 2014-03-31 2020-05-21 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin Fc fragment linkage
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
CN104327187B (zh) * 2014-10-11 2018-06-08 上海兴迪金生物技术有限公司 一种重组人GLP-1-Fc融合蛋白
WO2016077806A1 (en) * 2014-11-13 2016-05-19 AskGene Pharma, Inc. Fusion proteins with dual receptor agonist activities
PL3257524T3 (pl) * 2015-02-11 2021-03-08 Gmax Biopharm Llc Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r
US10993993B2 (en) * 2015-05-28 2021-05-04 Immunoforge Co., Ltd. Pharmaceutical composition for treating muscle atrophy or sarcopenia including glucagon-like peptide (GLP-1) or GLP-1 receptor agonist
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
AR105284A1 (es) 2015-07-10 2017-09-20 Sanofi Sa Derivados de exendina-4 como agonistas peptídicos duales específicos de los receptores de glp-1 / glucagón
KR102844773B1 (ko) 2015-12-23 2025-08-13 암젠 인크 위 억제 펩티드 수용체 (gipr)에 대한 결합 단백질을 glp-1 효능제와 조합하여 사용하여 대사 장애를 치료하거나 개선시키는 방법
GB201621987D0 (en) * 2016-12-22 2017-02-08 Archer Virgil L See Archer Sheri A Arecor Ltd Novel composition
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CN110831969B (zh) 2017-06-20 2024-06-21 安进公司 使用抑胃肽受体（gipr）结合蛋白与glp-1激动剂的组合治疗或改善代谢障碍的方法
MX2019015544A (es) 2017-06-21 2020-07-28 Amgen Inc Metodo para tratar o mejorar trastornos metabolicos con proteinas de fusion de agonistas del receptor de glp-1/proteinas de union antagonistas para el receptor peptidico inhibidor gastrico (gipr).
BR112020002871A2 (pt) 2017-08-15 2020-07-28 Kindred Biosciences, Inc. variantes fc de igg para uso veterinário
MX2020005231A (es) 2017-11-21 2020-08-24 Lilly Co Eli Metodos de uso y composiciones que contienen dulaglutida.
TWI829687B (zh) 2018-05-07 2024-01-21 丹麥商諾佛 儂迪克股份有限公司 包含glp-1促效劑與n-(8-(2-羥基苯甲醯基)胺基)辛酸之鹽的固體組成物
TWI705820B (zh) 2018-06-22 2020-10-01 美商美國禮來大藥廠 Gip/glp1促效劑組合物
WO2020190591A1 (en) 2019-03-15 2020-09-24 Eli Lilly And Company Preserved formulations
CA3177693A1 (en) 2019-04-05 2020-10-05 Eli Lilly And Company Therapeutic uses of dulaglutide
US20210187077A1 (en) * 2019-12-23 2021-06-24 Idaho State University GLP-1 Agonist Conjugates for Sustained Glycemic Control
CA3241537A1 (en) * 2021-12-31 2023-07-06 Jiangyu YAN Fusion protein of glp-1 and gdf15 and use thereof
TWI880227B (zh) * 2022-05-30 2025-04-11 丹麥商西蘭製藥公司 澱粉素類似物之液體調配物
WO2026021575A1 (zh) * 2024-07-26 2026-01-29 鸿运华宁（杭州）生物医药有限公司 一种gipr抗体融合蛋白质的药用稳定溶液制剂及其应用

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US5118666A (en) * 1986-05-05 1992-06-02 The General Hospital Corporation Insulinotropic hormone
JPH10503371A (ja) * 1994-07-29 1998-03-31 スミスクライン・ビーチャム・パブリック・リミテッド・カンパニー 新規化合物
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MXPA05013565A (es) * 2003-06-12 2006-03-09 Lilly Co Eli Proteinas de fusion analogas al glp-1.

Also Published As

Publication number Publication date
EP1831252B1 (en) 2009-07-01
ATE435235T1 (de) 2009-07-15
KR20070089187A (ko) 2007-08-30
ES2326906T3 (es) 2009-10-21
CN101044162A (zh) 2007-09-26
JP2008525452A (ja) 2008-07-17
UA87009C2 (ru) 2009-06-10
CA2589647A1 (en) 2006-06-29
PT1831252E (pt) 2009-09-17
HK1107570A1 (en) 2008-04-11
KR100879662B1 (ko) 2009-01-20
SI1831252T1 (sl) 2009-12-31
NO20073372L (no) 2007-07-16
DK1831252T3 (da) 2009-10-05
EA011166B1 (ru) 2009-02-27
EA200701364A1 (ru) 2007-10-26
PL1831252T3 (pl) 2009-11-30
EP2168982A1 (en) 2010-03-31
CN101044162B (zh) 2010-10-27
US20090232807A1 (en) 2009-09-17
EP1831252A1 (en) 2007-09-12
AU2005319432A1 (en) 2006-06-29
CY1109269T1 (el) 2014-07-02
IL183285A0 (en) 2007-09-20
WO2006068910A1 (en) 2006-06-29
MX2007007565A (es) 2007-07-24
DE602005015257D1 (pt) 2009-08-13

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]
B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]