EP4055005A4 - Liquid melphalan composition - Google Patents

Liquid melphalan composition Download PDF

Info

Publication number
EP4055005A4
EP4055005A4 EP20886165.8A EP20886165A EP4055005A4 EP 4055005 A4 EP4055005 A4 EP 4055005A4 EP 20886165 A EP20886165 A EP 20886165A EP 4055005 A4 EP4055005 A4 EP 4055005A4
Authority
EP
European Patent Office
Prior art keywords
liquid
melphalan composition
melphalan
composition
liquid melphalan
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
EP20886165.8A
Other languages
German (de)
French (fr)
Other versions
EP4055005A1 (en
Inventor
Nimitt CHOKSHI
Rushabh Shah
Nagnath G GOBADE
Kamal Kumar Upadhyay
Alex K George
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.)
Intas Pharmaceuticals Ltd
Original Assignee
Intas Pharmaceuticals 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 Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd
Publication of EP4055005A1 publication Critical patent/EP4055005A1/en
Publication of EP4055005A4 publication Critical patent/EP4055005A4/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/44—Stabilisation; Use of additives
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP20886165.8A 2019-11-04 2020-11-04 Liquid melphalan composition Pending EP4055005A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201921044683 2019-11-04
PCT/IB2020/060334 WO2021090183A1 (en) 2019-11-04 2020-11-04 Liquid melphalan composition

Publications (2)

Publication Number Publication Date
EP4055005A1 EP4055005A1 (en) 2022-09-14
EP4055005A4 true EP4055005A4 (en) 2023-11-29

Family

ID=75849601

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20886165.8A Pending EP4055005A4 (en) 2019-11-04 2020-11-04 Liquid melphalan composition

Country Status (2)

Country Link
EP (1) EP4055005A4 (en)
WO (1) WO2021090183A1 (en)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2060031C1 (en) * 1993-05-27 1996-05-20 Онкологический научный центр Method of sarcolysin preparing for intravenous injection

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11020363B2 (en) * 2009-05-29 2021-06-01 Cydex Pharmaceuticals, Inc. Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
CA2763365C (en) * 2009-05-29 2016-09-13 Cydex Pharmaceuticals, Inc. Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
US10537520B2 (en) * 2015-06-30 2020-01-21 Leiutis Pharmaceuticals Pvt. Ltd. Stable liquid formulations of melphalan
WO2017085696A1 (en) * 2015-11-20 2017-05-26 Leiutis Pharmaceuticals Pvt Ltd Parenteral formulations of melphalan

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2060031C1 (en) * 1993-05-27 1996-05-20 Онкологический научный центр Method of sarcolysin preparing for intravenous injection

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DAVID Q. MA ET AL: "Comparative effects of (SBE)7m-?-CD and HP-?-CD on the stability of two anti-neoplastic agents, melphalan and carmustine", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 89, no. 2, 1 February 2000 (2000-02-01), pages 275 - 287, XP055200060, ISSN: 0022-3549, DOI: 10.1002/(SICI)1520-6017(200002)89:2<275::AID-JPS15>3.0.CO;2-C *
See also references of WO2021090183A1 *

Also Published As

Publication number Publication date
EP4055005A1 (en) 2022-09-14
WO2021090183A1 (en) 2021-05-14

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DAV Request for validation of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20231027

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 31/198 20060101ALI20231023BHEP

Ipc: A61K 47/20 20060101ALI20231023BHEP

Ipc: A61K 47/12 20060101ALI20231023BHEP

Ipc: A61K 47/10 20170101ALI20231023BHEP

Ipc: A61K 47/02 20060101ALI20231023BHEP

Ipc: A61P 35/00 20060101ALI20231023BHEP

Ipc: A61K 9/08 20060101ALI20231023BHEP

Ipc: C07C 229/36 20060101AFI20231023BHEP