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WO2024231881A3 - Polymorphic forms and formulations of leriglitazone - Google Patents

Polymorphic forms and formulations of leriglitazone Download PDF

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Publication number
WO2024231881A3
WO2024231881A3 PCT/IB2024/054534 IB2024054534W WO2024231881A3 WO 2024231881 A3 WO2024231881 A3 WO 2024231881A3 IB 2024054534 W IB2024054534 W IB 2024054534W WO 2024231881 A3 WO2024231881 A3 WO 2024231881A3
Authority
WO
WIPO (PCT)
Prior art keywords
leriglitazone
formulations
polymorphic forms
crystalline forms
patient
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.)
Pending
Application number
PCT/IB2024/054534
Other languages
French (fr)
Other versions
WO2024231881A2 (en
Inventor
José Luis Fábregas Vidal
Montserrat MARTÍ PÉREZ
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.)
Minoryx Therapeutics SL
Original Assignee
Minoryx Therapeutics SL
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 Minoryx Therapeutics SL filed Critical Minoryx Therapeutics SL
Priority to AU2024268104A priority Critical patent/AU2024268104A1/en
Publication of WO2024231881A2 publication Critical patent/WO2024231881A2/en
Publication of WO2024231881A3 publication Critical patent/WO2024231881A3/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D417/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
    • C07D417/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings
    • C07D417/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

This disclosure provides crystalline forms of leriglitazone, pharmaceutical compositions or formulations comprising crystalline forms of leriglitazone, and methods of treating a disease, condition, or disorder in a patient comprising administering a composition comprising crystalline forms of leriglitazone to the patient.
PCT/IB2024/054534 2023-05-09 2024-05-09 Polymorphic forms and formulations of leriglitazone Pending WO2024231881A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024268104A AU2024268104A1 (en) 2023-05-09 2024-05-09 Polymorphic forms and formulations of leriglitazone

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23382428.3 2023-05-09
EP23382428 2023-05-09

Publications (2)

Publication Number Publication Date
WO2024231881A2 WO2024231881A2 (en) 2024-11-14
WO2024231881A3 true WO2024231881A3 (en) 2024-12-26

Family

ID=86331222

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/054534 Pending WO2024231881A2 (en) 2023-05-09 2024-05-09 Polymorphic forms and formulations of leriglitazone

Country Status (2)

Country Link
AU (1) AU2024268104A1 (en)
WO (1) WO2024231881A2 (en)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988000825A1 (en) * 1986-08-01 1988-02-11 Smith Kline & French Laboratories Limited Pharmaceutical formulations
EP0579733B1 (en) * 1991-04-11 2001-06-20 PHARMACIA & UPJOHN COMPANY Thiazolidinedione derivatives, production and use thereof
WO2013052114A1 (en) * 2011-10-05 2013-04-11 Fmc Corporation Stabilizer composition of microcrystalline cellulose and carboxymethylcellulose, method for making, and uses
WO2015150476A1 (en) * 2014-04-02 2015-10-08 Minoryx Therapeutics S.L. 2,4-thiazolidinedione derivatives in the treatment of central nervous system disorders
WO2016018860A1 (en) * 2014-07-29 2016-02-04 Fmc Corporation Improved colloidal stabilizer
WO2019234690A1 (en) * 2018-06-06 2019-12-12 Minoryx Therapeutics S.L. Use of 5-[[4-[2-[5-acetylpyridin-2-yl]ethoxy]benzyl]-1,3-thiazolidine-2,4-dione and its salts
WO2021220250A1 (en) * 2020-04-30 2021-11-04 Minoryx Therapeutics S.L. Leriglitazone for treating lung inflammation and interstitial lung disease

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2867300T3 (en) 2016-12-01 2021-10-20 Minoryx Therapeutics S L 5 - [[4- [2- [5- (1-hydroxyethyl) pyridin-2-yl] ethoxy] phenyl] methyl] -1,3-thiazolidine-2,4-dione for treatment of nonalcoholic fatty liver disease
LT3559010T (en) 2016-12-23 2022-10-10 Minoryx Therapeutics S.L. METHOD OF PREPARATION OF 5-[[4-[2-[5-(1-HYDROXYETHYL)-2-PYRIDINYL]ETHOXY]PHENYL]METHYL]-2,4-THIAZOLIDINDIONE AND ITS SALTS
CN112512524A (en) 2018-06-06 2021-03-16 米尼奥尔克斯治疗有限公司 Method of administering a therapeutically effective amount of 5- [ [4- [2- [5- (1-hydroxyethyl) pyridin-2-yl ] ethoxy ] phenyl ] methyl ] -1, 3-thiazolidine-2, 4-dione

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988000825A1 (en) * 1986-08-01 1988-02-11 Smith Kline & French Laboratories Limited Pharmaceutical formulations
EP0579733B1 (en) * 1991-04-11 2001-06-20 PHARMACIA & UPJOHN COMPANY Thiazolidinedione derivatives, production and use thereof
WO2013052114A1 (en) * 2011-10-05 2013-04-11 Fmc Corporation Stabilizer composition of microcrystalline cellulose and carboxymethylcellulose, method for making, and uses
WO2015150476A1 (en) * 2014-04-02 2015-10-08 Minoryx Therapeutics S.L. 2,4-thiazolidinedione derivatives in the treatment of central nervous system disorders
WO2016018860A1 (en) * 2014-07-29 2016-02-04 Fmc Corporation Improved colloidal stabilizer
WO2019234690A1 (en) * 2018-06-06 2019-12-12 Minoryx Therapeutics S.L. Use of 5-[[4-[2-[5-acetylpyridin-2-yl]ethoxy]benzyl]-1,3-thiazolidine-2,4-dione and its salts
WO2021220250A1 (en) * 2020-04-30 2021-11-04 Minoryx Therapeutics S.L. Leriglitazone for treating lung inflammation and interstitial lung disease

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
EUN HEE LEE: "A practical guide to pharmaceutical polymorph screening & selection", ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 9, no. 4, 16 March 2014 (2014-03-16), NL, pages 163 - 175, XP055260946, ISSN: 1818-0876, DOI: 10.1016/j.ajps.2014.05.002 *
MINO R CAIRA ED - MONTCHAMP JEAN-LUC: "CRYSTALLINE POLYMORPHISM OF ORGANIC COMPOUNDS", TOPICS IN CURRENT CHEMISTRY; [TOPICS IN CURRENT CHEMISTRY], SPRINGER, BERLIN, DE, vol. 198, 1 January 1998 (1998-01-01), pages 163 - 208, XP001156954, ISSN: 0340-1022, [retrieved on 19990226], DOI: 10.1007/3-540-69178-2_5 *
SOHDA: "Studies on Antidiabetic Agents. XII. Synthesis and Activity of the Metabolites of ( )-5-[p-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl]-2, 4-thiazolidinedione (Pioglitazone)", CHEM. PHARM. BULL., vol. 43, no. 12, 1 January 1995 (1995-01-01), pages 2168 - 2172, XP093187153 *
STEPHEN BYRN ET AL: "Pharmaceutical Solids: A strategic Approach to Regulatory Considerations", ENVIRONMENTAL SCIENCE AND POLLUTION RESEARCH, SPRINGER BERLIN HEIDELBERG, BERLIN/HEIDELBERG, vol. 12, no. 7, 1 July 1995 (1995-07-01), pages 945 - 954, XP000996386, ISSN: 0724-8741, DOI: 10.1023/A:1016241927429 *

Also Published As

Publication number Publication date
WO2024231881A2 (en) 2024-11-14
AU2024268104A1 (en) 2025-11-27

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