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MX2021004331A - Composiciones estables de semaglutida y usos de las mismas. - Google Patents

Composiciones estables de semaglutida y usos de las mismas.

Info

Publication number
MX2021004331A
MX2021004331A MX2021004331A MX2021004331A MX2021004331A MX 2021004331 A MX2021004331 A MX 2021004331A MX 2021004331 A MX2021004331 A MX 2021004331A MX 2021004331 A MX2021004331 A MX 2021004331A MX 2021004331 A MX2021004331 A MX 2021004331A
Authority
MX
Mexico
Prior art keywords
stable
compositions
semaglutide
semaglutide compositions
glp
Prior art date
Application number
MX2021004331A
Other languages
English (en)
Inventor
Joakim Lundqvist
Dorthe Kot Engelund
Søren Skov Jensen
Original Assignee
Novo Nordisk As
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=68503076&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2021004331(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk As filed Critical Novo Nordisk As
Publication of MX2021004331A publication Critical patent/MX2021004331A/es

Links

Classifications

    • 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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P3/04—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

Landscapes

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

Abstract

La presente invención se refiere a composiciones farmacéuticas del péptido GLP-1 semaglutida que comprenden un estabilizador tal como histidina, su preparación, kits que comprenden tales composiciones, así como también los usos médicos de las mismas.
MX2021004331A 2018-10-26 2019-10-25 Composiciones estables de semaglutida y usos de las mismas. MX2021004331A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18202801 2018-10-26
EP19158226 2019-02-20
PCT/EP2019/079214 WO2020084126A1 (en) 2018-10-26 2019-10-25 Stable semaglutide compositions and uses thereof

Publications (1)

Publication Number Publication Date
MX2021004331A true MX2021004331A (es) 2021-05-27

Family

ID=68503076

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021004331A MX2021004331A (es) 2018-10-26 2019-10-25 Composiciones estables de semaglutida y usos de las mismas.

Country Status (22)

Country Link
US (1) US20210379159A1 (es)
EP (1) EP3870213B1 (es)
JP (1) JP7422754B2 (es)
KR (1) KR20210087465A (es)
CN (1) CN112912100A (es)
AU (1) AU2019363725B2 (es)
BR (1) BR112021006598A2 (es)
CA (1) CA3116271A1 (es)
CL (1) CL2021000938A1 (es)
CO (1) CO2021005915A2 (es)
ES (1) ES2954584T3 (es)
HR (1) HRP20230929T1 (es)
HU (1) HUE062893T2 (es)
IL (1) IL281938B2 (es)
MX (1) MX2021004331A (es)
PE (1) PE20211492A1 (es)
PH (1) PH12021550705A1 (es)
PL (1) PL3870213T3 (es)
RS (1) RS64438B1 (es)
SA (1) SA521421715B1 (es)
SG (1) SG11202103137WA (es)
WO (1) WO2020084126A1 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112912100A (zh) 2018-10-26 2021-06-04 诺和诺德股份有限公司 稳定的司美鲁肽组合物及其用途
WO2021105393A1 (en) * 2019-11-29 2021-06-03 Novo Nordisk A/S Processes for obtaining stable glp-1 compositions
KR20220143036A (ko) 2020-02-18 2022-10-24 노보 노르디스크 에이/에스 약학적 제형
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
WO2023083301A1 (zh) * 2021-11-12 2023-05-19 福建盛迪医药有限公司 Glp-1受体和gip受体双重激动剂的药物组合物及其用途
CN114660214B (zh) * 2022-02-18 2024-04-05 兰州积石药业有限公司 一种司美格鲁肽的液相色谱检测方法及其应用

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUT69402A (en) 1991-12-20 1995-09-28 Novo Nordisk As Process for producing stabilized pharmaceutical formulations comprising growth hormone and histidine
DK136492D0 (da) * 1992-11-10 1992-11-10 Novo Nordisk As A pharmaceutical formulation
EP1030688B1 (en) * 1997-11-12 2004-09-29 Alza Corporation Method for dermally administering polypeptides
GB9930882D0 (en) 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
ATE382057T1 (de) 2001-06-28 2008-01-15 Novo Nordisk As Stabile formulierung von modifiziertem glp-1
US20060287221A1 (en) * 2003-11-13 2006-12-21 Novo Nordisk A/S Soluble pharmaceutical compositions for parenteral administration comprising a GLP-1 peptide and an insulin peptide of short time action for treatment of diabetes and bulimia
CN104826116A (zh) * 2003-11-20 2015-08-12 诺沃挪第克公司 对于生产和用于注射装置中是最佳的含有丙二醇的肽制剂
EP1791554A2 (en) * 2004-09-17 2007-06-06 Novo Nordisk A/S Pharmaceutical compositions containing insulin and insulinotropic peptide
TWI372629B (en) * 2005-03-18 2012-09-21 Novo Nordisk As Acylated glp-1 compounds
EP2036539A1 (en) * 2007-09-11 2009-03-18 Novo Nordisk A/S Stable formulations of amylin and its analogues
WO2011109787A1 (en) * 2010-03-05 2011-09-09 Conjuchem, Llc Methods of administering insulinotropic peptides
DK2651398T3 (en) 2010-12-16 2018-03-12 Novo Nordisk As Solid compositions comprising a GLP-1 agonist and a salt of N- (8- (2-hydroxybenzyl) amino) caprylic acid
US20120208755A1 (en) * 2011-02-16 2012-08-16 Intarcia Therapeutics, Inc. Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers
ES2810153T3 (es) 2012-03-01 2021-03-08 Novo Nordisk As Profármacos de GLP-1
RS57727B1 (sr) 2012-03-22 2018-12-31 Novo Nordisk As Kompozicije glp-1 peptida i njihovo dobijanje
CN103566354B (zh) * 2012-07-25 2017-12-05 江苏豪森药业集团有限公司 含有glp‑1类似物的衍生物或其可药用盐的药物组合物
US20150273069A1 (en) * 2012-10-17 2015-10-01 Novo Nordisk A/S Fatty acid acylated amino acids for oral peptide delivery
WO2014124096A1 (en) * 2013-02-06 2014-08-14 Perosphere Inc. Stable glucagon formulations
JP2014214153A (ja) * 2013-04-30 2014-11-17 ニプロ株式会社 水溶液製剤およびその製造方法
KR20160021183A (ko) * 2013-06-20 2016-02-24 노보 노르디스크 에이/에스 Glp-1 유도체 및 그것의 용도
WO2016038521A1 (en) * 2014-09-08 2016-03-17 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of liraglutide
WO2016077220A1 (en) * 2014-11-10 2016-05-19 Mb2 Llc Gip/glp-1 co-agonist peptides for human administration
US11572398B2 (en) * 2014-11-27 2023-02-07 Novo Nordisk A/S GLP-1 derivatives and uses thereof
TWI622596B (zh) * 2015-10-26 2018-05-01 美國禮來大藥廠 升糖素受體促效劑
KR20180135012A (ko) * 2016-04-28 2018-12-19 노보 노르디스크 에이/에스 심혈관 병태에서의 세마글루타이드
CN107661288A (zh) * 2016-07-29 2018-02-06 江苏泰康生物医药有限公司 含有glp‑1 类似物融合蛋白的稳定液体制剂及其制备
CN107952064B (zh) * 2016-10-14 2023-10-20 江苏豪森药业集团有限公司 含有聚乙二醇洛塞那肽的药物制剂及其制备方法
CN108210890A (zh) * 2016-12-09 2018-06-29 江苏泰康生物医药有限公司 重组人胰高血糖素样肽-1类似物融合蛋白的新型稳定制剂
GB201621987D0 (en) * 2016-12-22 2017-02-08 Archer Virgil L See Archer Sheri A Arecor Ltd Novel composition
CN112912100A (zh) 2018-10-26 2021-06-04 诺和诺德股份有限公司 稳定的司美鲁肽组合物及其用途

Also Published As

Publication number Publication date
BR112021006598A2 (pt) 2021-07-06
CA3116271A1 (en) 2020-04-30
PE20211492A1 (es) 2021-08-11
AU2019363725A1 (en) 2021-05-20
RS64438B1 (sr) 2023-09-29
CN112912100A (zh) 2021-06-04
CO2021005915A2 (es) 2021-08-09
AU2019363725B2 (en) 2024-05-02
JP7422754B2 (ja) 2024-01-26
IL281938B2 (en) 2024-04-01
JP2022505290A (ja) 2022-01-14
SG11202103137WA (en) 2021-04-29
CL2021000938A1 (es) 2021-09-10
HUE062893T2 (hu) 2023-12-28
WO2020084126A1 (en) 2020-04-30
EP3870213A1 (en) 2021-09-01
IL281938A (en) 2021-05-31
IL281938B1 (en) 2023-12-01
ES2954584T3 (es) 2023-11-23
HRP20230929T1 (hr) 2023-11-24
US20210379159A1 (en) 2021-12-09
PL3870213T3 (pl) 2023-11-20
PH12021550705A1 (en) 2021-11-03
EP3870213C0 (en) 2023-06-07
EP3870213B1 (en) 2023-06-07
KR20210087465A (ko) 2021-07-12
SA521421715B1 (ar) 2023-12-10

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