WO2020044114A3 - Methotrexate pharmaceutical composition - Google Patents

Methotrexate pharmaceutical composition

Info

Publication number
WO2020044114A3
WO2020044114A3 PCT/IB2019/000949 IB2019000949W WO2020044114A3 WO 2020044114 A3 WO2020044114 A3 WO 2020044114A3 IB 2019000949 W IB2019000949 W IB 2019000949W WO 2020044114 A3 WO2020044114 A3 WO 2020044114A3
Authority
WO
WIPO (PCT)
Prior art keywords
patients
methotrexate
absence
pharmaceutical composition
prior
Prior art date
Application number
PCT/IB2019/000949
Other languages
French (fr)
Other versions
WO2020044114A2 (en
Inventor
Hardik PRAJAPATI
Sandip Mehta
Manish UMRETHIA
Jayanta Kumar Mandal
Original Assignee
Ftf Pharma Private 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 Ftf Pharma Private Limited filed Critical Ftf Pharma Private Limited
Priority to GB2104388.0A priority Critical patent/GB2591681A/en
Publication of WO2020044114A2 publication Critical patent/WO2020044114A2/en
Publication of WO2020044114A3 publication Critical patent/WO2020044114A3/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Though oral liquid formulations of Methotrexate are advantageous as they can suitably be administered to the patients having swallowing difficulties such as pediatric patients, geriatric patients, stroke patients or patients who are unable to take solid oral therapy, they are not much explored in the prior art. Further, liquid formulations of Methotrexate known in the prior art have not been explored at higher pH and in the absence of additional solubilizing agents. An aim of the present invention is therefore to provide chemically and physically stable liquid pharmaceutical compositions of Methotrexate at higher pH and in the absence of solubilizing agents.
PCT/IB2019/000949 2018-08-29 2019-08-29 Methotrexate pharmaceutical composition WO2020044114A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB2104388.0A GB2591681A (en) 2018-08-29 2019-08-29 Methotrexate pharmaceutical composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821032299 2018-08-29
IN201821032299 2018-08-29

Publications (2)

Publication Number Publication Date
WO2020044114A2 WO2020044114A2 (en) 2020-03-05
WO2020044114A3 true WO2020044114A3 (en) 2020-04-09

Family

ID=68582041

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/000949 WO2020044114A2 (en) 2018-08-29 2019-08-29 Methotrexate pharmaceutical composition

Country Status (2)

Country Link
GB (1) GB2591681A (en)
WO (1) WO2020044114A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115778897A (en) * 2022-12-15 2023-03-14 深圳市贝美药业有限公司 Stable methotrexate pharmaceutical preparation and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050101605A1 (en) * 2003-11-07 2005-05-12 Ahmed Salah U. Oral liquid formulations of methotrexate
US9259427B2 (en) * 2012-01-06 2016-02-16 Rosemont Pharmaceuticals Ltd Methotrexate composition
US20170246172A1 (en) * 2006-07-21 2017-08-31 Medac Gesellschaft Fuer Klinische Spezialpraepararate Mbh Concentrated methotrexate solutions
US20170312281A1 (en) * 2014-10-29 2017-11-02 Therakind Ltd. Methotrexate formulation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4474752A (en) 1983-05-16 1984-10-02 Merck & Co., Inc. Drug delivery system utilizing thermosetting gels
US5472954A (en) 1992-07-14 1995-12-05 Cyclops H.F. Cyclodextrin complexation
US5925669A (en) 1994-03-22 1999-07-20 Molecular/Structural Bio Technologies, Inc. Carrier compositions for anti-neoplastic drugs
US5770585A (en) 1995-05-08 1998-06-23 Kaufman; Robert J. Homogeneous water-in-perfluorochemical stable liquid dispersion for administration of a drug to the lung of an animal
SE9502244D0 (en) 1995-06-20 1995-06-20 Bioglan Ab A composition and a process for the preparation thereof
US6383471B1 (en) 1999-04-06 2002-05-07 Lipocine, Inc. Compositions and methods for improved delivery of ionizable hydrophobic therapeutic agents
US6309663B1 (en) 1999-08-17 2001-10-30 Lipocine Inc. Triglyceride-free compositions and methods for enhanced absorption of hydrophilic therapeutic agents

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050101605A1 (en) * 2003-11-07 2005-05-12 Ahmed Salah U. Oral liquid formulations of methotrexate
US20170246172A1 (en) * 2006-07-21 2017-08-31 Medac Gesellschaft Fuer Klinische Spezialpraepararate Mbh Concentrated methotrexate solutions
US9259427B2 (en) * 2012-01-06 2016-02-16 Rosemont Pharmaceuticals Ltd Methotrexate composition
US20170312281A1 (en) * 2014-10-29 2017-11-02 Therakind Ltd. Methotrexate formulation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HANSEN J ET AL: "Kinetics of degradation of methotrexate in aqueous solution", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER, NL, vol. 16, no. 2, 1 September 1983 (1983-09-01), pages 141 - 152, XP023844715, ISSN: 0378-5173, [retrieved on 19830901], DOI: 10.1016/0378-5173(83)90051-0 *

Also Published As

Publication number Publication date
GB202104388D0 (en) 2021-05-12
WO2020044114A2 (en) 2020-03-05
GB2591681A (en) 2021-08-04

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