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WO2016038521A8 - Pharmaceutical compositions of liraglutide - Google Patents

Pharmaceutical compositions of liraglutide Download PDF

Info

Publication number
WO2016038521A8
WO2016038521A8 PCT/IB2015/056775 IB2015056775W WO2016038521A8 WO 2016038521 A8 WO2016038521 A8 WO 2016038521A8 IB 2015056775 W IB2015056775 W IB 2015056775W WO 2016038521 A8 WO2016038521 A8 WO 2016038521A8
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical compositions
liraglutide
relates
present
compositions
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/IB2015/056775
Other languages
French (fr)
Other versions
WO2016038521A1 (en
Inventor
Ravindra Agarwal
Bhaskar Chauhan
Ravi Kochhar
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.)
Sun Pharmaceutical Industries Ltd
Original Assignee
Sun Pharmaceutical Industries 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 Sun Pharmaceutical Industries Ltd filed Critical Sun Pharmaceutical Industries Ltd
Publication of WO2016038521A1 publication Critical patent/WO2016038521A1/en
Publication of WO2016038521A8 publication Critical patent/WO2016038521A8/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K47/06—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to pharmaceutical compositions comprising: (i) liraglutide; (ii) a buffer selected from the group consisting of dipotassium phosphate, sodium bicarbonate, and disodium phosphate anhydrous; (iii) propylene glycol; and (iv) a preservative. The compositions of the present invention remain stable after exposure to multiple freeze-thaw cycles or after being subjected to elevated temperature. It also relates to processes for the preparation of said pharmaceutical compositions.
PCT/IB2015/056775 2014-09-08 2015-09-04 Pharmaceutical compositions of liraglutide Ceased WO2016038521A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2558DE2014 2014-09-08
IN2558/DEL/2014 2014-09-08

Publications (2)

Publication Number Publication Date
WO2016038521A1 WO2016038521A1 (en) 2016-03-17
WO2016038521A8 true WO2016038521A8 (en) 2016-06-16

Family

ID=55458399

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2015/056775 Ceased WO2016038521A1 (en) 2014-09-08 2015-09-04 Pharmaceutical compositions of liraglutide

Country Status (1)

Country Link
WO (1) WO2016038521A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019535835A (en) * 2016-11-22 2019-12-12 バイオコン リサーチ リミテッドＢｉｏｃｏｎ Ｒｅｓｅａｒｃｈ Ｌｉｍｉｔｅｄ Pharmaceutical composition of GLP-1 analogue
CA3082033A1 (en) 2017-08-24 2019-02-28 Novo Nordisk A\S Glp-1 compositions and uses thereof
CN120617158A (en) * 2018-10-26 2025-09-12 诺和诺德股份有限公司 Stable semanteme peptide composition and use thereof
WO2020127476A1 (en) 2018-12-19 2020-06-25 Krka, D.D., Novo Mesto Pharmaceutical composition comprising glp-1 analogue
WO2020208541A1 (en) 2019-04-08 2020-10-15 Enzene Biosciences Limited Composition comprising glp-1 analogue
WO2021123228A1 (en) 2019-12-18 2021-06-24 Krka, D.D., Novo Mesto Pharmaceutical composition comprising glp-1 analogue
PE20221575A1 (en) 2020-02-18 2022-10-06 Novo Nordisk As PHARMACEUTICAL FORMULATIONS
GR1010977B (en) * 2024-05-23 2025-06-13 Φαρματεν Α.Β.Ε.Ε., Parenteral formulation of a glucagon-like peptide-1 analogue and method for preparation thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5562510B2 (en) * 2001-06-28 2014-07-30 ノヴォ ノルディスク アー／エス Stable formulation of modified GLP-1
CN102784386A (en) * 2003-11-20 2012-11-21 诺沃挪第克公司 Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
WO2009075859A2 (en) * 2007-12-11 2009-06-18 Conjuchem Biotechnologies Inc. Formulation of insulinotropic peptide conjugates

Also Published As

Publication number Publication date
WO2016038521A1 (en) 2016-03-17

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