WO2020208541A1 - Composition comprenant un analogue de glp-1 - Google Patents

Composition comprenant un analogue de glp-1 Download PDF

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Publication number
WO2020208541A1
WO2020208541A1 PCT/IB2020/053345 IB2020053345W WO2020208541A1 WO 2020208541 A1 WO2020208541 A1 WO 2020208541A1 IB 2020053345 W IB2020053345 W IB 2020053345W WO 2020208541 A1 WO2020208541 A1 WO 2020208541A1
Authority
WO
WIPO (PCT)
Prior art keywords
glp
analogue
liraglutide
present
pharmaceutical composition
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2020/053345
Other languages
English (en)
Inventor
Nildip CHAUHAN
Abijar BHORI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Enzene Biosciences Ltd
Original Assignee
Enzene Biosciences Ltd
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
Application filed by Enzene Biosciences Ltd filed Critical Enzene Biosciences Ltd
Publication of WO2020208541A1 publication Critical patent/WO2020208541A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K38/26—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
    • 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
    • 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

Definitions

  • the present invention relates to a pharmaceutical composition wherein the GLP-1 analogue is the active drug substance.
  • the present invention relates to method of using the composition comprising GLP-1 analogue or its pharmaceutically acceptable salts, complexes, polymorphs, hydrates, solvates, enantiomers or racemates thereof.
  • the pharmaceutical compositions comprising GLP- 1 analogues according to the present invention are particularly useful for the treatment of disease(s) or disorder(s) which are particularly acute in nature and which require a short term but mild to moderate treatment, or even some chronic conditions which favorably respond to or are alleviated by the pharmaceutical compositions comprising GLP-1 analogues.
  • the pharmaceutical compositions comprising GLP-1 analogues are useful prophylactically or therapeutically depending upon the pathological condition intended to be prevented or treated respectively.
  • a pharmaceutical formulation is found to be physically unstable when it exhibits turbidity. Physical stability of the formulations is evaluated by means of visual inspection and turbidity after storage of the formulation at different temperatures in top fdled glass cartridges for various time periods. Visual inspection of the formulations is performed in a sharp focused light with a dark background. A formulation is classified physical unstable with respect to protein aggregation, when it shows visual turbidity in daylight. [00104] In one embodiment, the pharmaceutical composition according to the present invention is physically stable for a period of Bout 10-25 days at about 40 °C.
  • Formulations of semaglutide were prepared as per Examples 1 and 2 compositions and following the method as per Example 1, except that the liraglutide was replaced with semaglutide in all the compositions formulated.

Landscapes

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

Abstract

La présente invention concerne une composition pharmaceutique comprenant un analogue de GLP-1, ses sels, complexes, polymorphes, hydrates, solvates, énantiomères ou racémates pharmaceutiquement acceptables. La présente invention concerne en outre une composition liquide comprenant un analogue de GLP-1 ou ses sels, complexes, polymorphes, hydrates, solvates, énantiomères ou racémates pharmaceutiquement acceptables, des procédés de préparation de la composition et des procédés d'utilisation de celle-ci. Plus particulièrement, la présente invention concerne une composition liquide comprenant du liraglutide, du sémaglutide, du D-liraglutide, du D-sémaglutide ou un autre analogue de GLP-1 de celle-ci, des procédés de préparation de la composition et des procédés d'utilisation de celle-ci.
PCT/IB2020/053345 2019-04-08 2020-04-08 Composition comprenant un analogue de glp-1 Ceased WO2020208541A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201921014160 2019-04-08
IN201921014160 2019-04-08

Publications (1)

Publication Number Publication Date
WO2020208541A1 true WO2020208541A1 (fr) 2020-10-15

Family

ID=70476268

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2020/053345 Ceased WO2020208541A1 (fr) 2019-04-08 2020-04-08 Composition comprenant un analogue de glp-1

Country Status (1)

Country Link
WO (1) WO2020208541A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114146163A (zh) * 2021-12-07 2022-03-08 苏州天马医药集团天吉生物制药有限公司 司美格鲁肽制剂的制备方法
CN116763763A (zh) * 2022-12-05 2023-09-19 齐鲁制药有限公司 一种司美格鲁肽吸入喷雾剂及其制备方法
WO2023238017A1 (fr) * 2022-06-08 2023-12-14 Zydus Lifesciences Limited Injecteur en stylo unique à dose variable multidose réutilisable pour le traitement du diabète de type 2 et la gestion du poids
RU2855486C1 (ru) * 2020-12-16 2026-02-02 Зилэнд Фарма А/С Фармацевтическая композиция двойных агонистов glp-1/glp-2

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000037098A1 (fr) * 1998-12-22 2000-06-29 Eli Lilly And Company Formulation de longue conservation de peptide-1 de type glucagon
WO2003002136A2 (fr) 2001-06-28 2003-01-09 Novo Nordisk A/S Formulation stable de glp-1 modifie
WO2005049061A2 (fr) * 2003-11-20 2005-06-02 Novo Nordisk A/S Formulations peptidiques a base de propylene glycol optimales pour la production et l'utilisation dans des dispositifs d'injection
WO2006051110A2 (fr) * 2004-11-12 2006-05-18 Novo Nordisk A/S Formulations stables de peptides
CN103800301A (zh) 2013-12-27 2014-05-21 深圳市健元医药科技有限公司 治疗糖尿病的脉冲给药组合物及其制备方法
WO2016038521A1 (fr) 2014-09-08 2016-03-17 Sun Pharmaceutical Industries Limited Compositions pharmaceutiques de liraglutide
EP3034090A1 (fr) * 2013-08-13 2016-06-22 Shanghai Benemae Pharmaceutical Corporation Composition pharmaceutique stable pour l'hydro-injection de peptide sécrétagogue d'insuline
US20170326069A1 (en) * 2009-11-13 2017-11-16 Sanofi-Aventis Deutschland Gmbh Pharmaceutical Composition Comprising a GLP-1-Agonist and Methionine
WO2018096460A1 (fr) 2016-11-22 2018-05-31 Biocon Research Limited Compositions pharmaceutiques d'analogues de glp-1
WO2018115901A1 (fr) * 2016-12-22 2018-06-28 Arecor Limited Compositions d'agoniste de récepteur du peptide 1 apparenté au glucagon (glp-1)
WO2019038412A1 (fr) * 2017-08-24 2019-02-28 Novo Nordisk A/S Compositions de glp-1 et leurs utilisations

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000037098A1 (fr) * 1998-12-22 2000-06-29 Eli Lilly And Company Formulation de longue conservation de peptide-1 de type glucagon
US8846618B2 (en) 2001-06-28 2014-09-30 Novo Nordisk A/S Stable formulation of modified GLP-1
WO2003002136A2 (fr) 2001-06-28 2003-01-09 Novo Nordisk A/S Formulation stable de glp-1 modifie
WO2005049061A2 (fr) * 2003-11-20 2005-06-02 Novo Nordisk A/S Formulations peptidiques a base de propylene glycol optimales pour la production et l'utilisation dans des dispositifs d'injection
US8114833B2 (en) 2003-11-20 2012-02-14 Novo Nordisk A/S Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
WO2006051110A2 (fr) * 2004-11-12 2006-05-18 Novo Nordisk A/S Formulations stables de peptides
US20170326069A1 (en) * 2009-11-13 2017-11-16 Sanofi-Aventis Deutschland Gmbh Pharmaceutical Composition Comprising a GLP-1-Agonist and Methionine
EP3034090A1 (fr) * 2013-08-13 2016-06-22 Shanghai Benemae Pharmaceutical Corporation Composition pharmaceutique stable pour l'hydro-injection de peptide sécrétagogue d'insuline
CN103800301A (zh) 2013-12-27 2014-05-21 深圳市健元医药科技有限公司 治疗糖尿病的脉冲给药组合物及其制备方法
WO2016038521A1 (fr) 2014-09-08 2016-03-17 Sun Pharmaceutical Industries Limited Compositions pharmaceutiques de liraglutide
WO2018096460A1 (fr) 2016-11-22 2018-05-31 Biocon Research Limited Compositions pharmaceutiques d'analogues de glp-1
WO2018115901A1 (fr) * 2016-12-22 2018-06-28 Arecor Limited Compositions d'agoniste de récepteur du peptide 1 apparenté au glucagon (glp-1)
WO2019038412A1 (fr) * 2017-08-24 2019-02-28 Novo Nordisk A/S Compositions de glp-1 et leurs utilisations

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2855486C1 (ru) * 2020-12-16 2026-02-02 Зилэнд Фарма А/С Фармацевтическая композиция двойных агонистов glp-1/glp-2
RU2855506C1 (ru) * 2020-12-16 2026-02-02 Зилэнд Фарма А/С Фармацевтическая композиция двойных агонистов glp-1/glp-2
CN114146163A (zh) * 2021-12-07 2022-03-08 苏州天马医药集团天吉生物制药有限公司 司美格鲁肽制剂的制备方法
CN114146163B (zh) * 2021-12-07 2023-09-26 苏州天马医药集团天吉生物制药有限公司 司美格鲁肽制剂的制备方法
WO2023238017A1 (fr) * 2022-06-08 2023-12-14 Zydus Lifesciences Limited Injecteur en stylo unique à dose variable multidose réutilisable pour le traitement du diabète de type 2 et la gestion du poids
CN116763763A (zh) * 2022-12-05 2023-09-19 齐鲁制药有限公司 一种司美格鲁肽吸入喷雾剂及其制备方法
CN116763763B (zh) * 2022-12-05 2024-08-30 齐鲁制药有限公司 一种司美格鲁肽吸入喷雾剂及其制备方法

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