PE20211492A1 - Composiciones estables de semaglutida y usos de las mismas - Google Patents

Composiciones estables de semaglutida y usos de las mismas

Info

Publication number
PE20211492A1
PE20211492A1 PE2021000506A PE2021000506A PE20211492A1 PE 20211492 A1 PE20211492 A1 PE 20211492A1 PE 2021000506 A PE2021000506 A PE 2021000506A PE 2021000506 A PE2021000506 A PE 2021000506A PE 20211492 A1 PE20211492 A1 PE 20211492A1
Authority
PE
Peru
Prior art keywords
semaglutide
same
stable compositions
histidine
compositions
Prior art date
Application number
PE2021000506A
Other languages
English (en)
Inventor
Dorthe Kot Engelund
Søren Skov Jensen
Joakim Lundqvist
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=PE20211492(A1) "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 PE20211492A1 publication Critical patent/PE20211492A1/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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Esta referido a composiciones farmaceuticas que comprenden al peptido GLP-1 semaglutida, un agente isotonico e histidina, en donde la concentracion de histidina es 0,5-100 mM y en donde el pH de la composicion esta en el intervalo de 6,0-10,0. Estas composiciones tienen una estabilidad quimica y/o fisica mejorada, la cual da como resultado beneficios para el paciente en forma de una vida util mas prolongada y un periodo de uso mas prolongado. Se emplea para el uso en el tratamiento de la diabetes o la obesidad.
PE2021000506A 2018-10-26 2019-10-25 Composiciones estables de semaglutida y usos de las mismas PE20211492A1 (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
PE20211492A1 true PE20211492A1 (es) 2021-08-11

Family

ID=68503076

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2021000506A PE20211492A1 (es) 2018-10-26 2019-10-25 Composiciones estables de semaglutida y usos de las mismas

Country Status (21)

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)
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
CA3116271A1 (en) 2018-10-26 2020-04-30 Novo Nordisk A/S Stable semaglutide compositions and uses thereof
WO2021105393A1 (en) * 2019-11-29 2021-06-03 Novo Nordisk A/S Processes for obtaining stable glp-1 compositions
AU2021207313A1 (en) 2020-02-18 2022-07-28 Novo Nordisk A/S Pharmaceutical formulations
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
CN118103391A (zh) * 2021-11-12 2024-05-28 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 (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK136492D0 (da) * 1992-11-10 1992-11-10 Novo Nordisk As A pharmaceutical formulation
DE69232847T2 (de) 1991-12-20 2003-09-11 Novo Nordisk As Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält
ES2230727T3 (es) 1997-11-12 2005-05-01 Alza Corporation Procedimiento de administracion dermal de polipeptidos.
GB9930882D0 (en) 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
US20030119734A1 (en) 2001-06-28 2003-06-26 Flink James M. Stable formulation of modified 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
PT3300721T (pt) 2003-11-20 2019-06-06 Novo Nordisk As Formulações peptidicas contendo propileno glicol que sao ideais para a produção e para utilizacao em dispositivos de injeção
WO2006029634A2 (en) * 2004-09-17 2006-03-23 Novo Nordisk A/S Pharmaceutical compositions containing insulin and insulinotropic peptide
TWI362392B (en) 2005-03-18 2012-04-21 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
JP5902194B2 (ja) 2010-12-16 2016-04-13 ノヴォ ノルディスク アー／エス Ｇｌｐ−１アゴニストとｎ−（８−（２−ヒドロキシベンゾイル）アミノ）カプリル酸の塩とを含む固形組成物
US20120208755A1 (en) * 2011-02-16 2012-08-16 Intarcia Therapeutics, Inc. Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers
WO2013127779A1 (en) 2012-03-01 2013-09-06 Novo Nordisk A/S Glp-1 prodrugs
ES2952874T3 (es) 2012-03-22 2023-11-06 Novo Nordisk As Composiciones de péptidos GLP-1 y preparación de estas
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
US9956287B2 (en) * 2013-02-06 2018-05-01 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
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
WO2016083499A1 (en) * 2014-11-27 2016-06-02 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
JP7221694B2 (ja) * 2016-04-28 2023-02-14 ノヴォ ノルディスク アー／エス 心血管状態におけるセマグルチド
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
CA3116271A1 (en) 2018-10-26 2020-04-30 Novo Nordisk A/S Stable semaglutide compositions and uses thereof

Also Published As

Publication number Publication date
IL281938B1 (en) 2023-12-01
KR20210087465A (ko) 2021-07-12
JP2022505290A (ja) 2022-01-14
EP3870213A1 (en) 2021-09-01
PH12021550705A1 (en) 2021-11-03
SG11202103137WA (en) 2021-04-29
IL281938A (en) 2021-05-31
BR112021006598A2 (pt) 2021-07-06
PL3870213T3 (pl) 2023-11-20
IL281938B2 (en) 2024-04-01
CN112912100A (zh) 2021-06-04
MX2021004331A (es) 2021-05-27
AU2019363725B2 (en) 2024-05-02
CA3116271A1 (en) 2020-04-30
HRP20230929T1 (hr) 2023-11-24
EP3870213B1 (en) 2023-06-07
EP3870213C0 (en) 2023-06-07
ES2954584T3 (es) 2023-11-23
AU2019363725A1 (en) 2021-05-20
JP7422754B2 (ja) 2024-01-26
CL2021000938A1 (es) 2021-09-10
CO2021005915A2 (es) 2021-08-09
WO2020084126A1 (en) 2020-04-30
HUE062893T2 (hu) 2023-12-28
US20210379159A1 (en) 2021-12-09
RS64438B1 (sr) 2023-09-29

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