WO2016038521A8 - Pharmaceutical compositions of liraglutide - Google Patents

Pharmaceutical compositions of liraglutide Download PDF

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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
Application number
PCT/IB2015/056775
Other languages
French (fr)
Other versions
WO2016038521A1 (en
Inventor
Ravindra Agarwal
Bhaskar Chauhan
Ravi Kochhar
Original Assignee
Sun Pharmaceutical Industries Limited
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 Limited filed Critical Sun Pharmaceutical Industries Limited
Publication of WO2016038521A1 publication Critical patent/WO2016038521A1/en
Publication of WO2016038521A8 publication Critical patent/WO2016038521A8/en

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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (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 WO2016038521A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2558/DEL/2014 2014-09-08
IN2558DE2014 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 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 (7)

* 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
TWI783890B (en) 2017-08-24 2022-11-11 丹麥商諾佛 儂迪克股份有限公司 Glp-1 compositions and uses thereof
HRP20230929T1 (en) * 2018-10-26 2023-11-24 Novo Nordisk A/S Stable semaglutide compositions and uses 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
CA3165359A1 (en) 2020-02-18 2021-07-22 Dorthe Kot Engelund Glp-1 compositions and uses thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE60224284T2 (en) * 2001-06-28 2008-12-18 Novo Nordisk A/S STABLE FORMULATION OF MODIFIED GLP-1
AU2004290862B2 (en) * 2003-11-20 2010-06-03 Novo Nordisk A/S Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
CN102026666B (en) * 2007-12-11 2013-10-16 常山凯捷健生物药物研发（河北）有限公司 Formulation of insulinotropic peptide conjugates

Also Published As

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

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