EP4055005A4 - Composition liquide de melphalan - Google Patents

Composition liquide de melphalan Download PDF

Info

Publication number: EP4055005A4
Authority: EP; European Patent Office
Prior art keywords: liquid; melphalan composition; melphalan; composition; liquid melphalan
Prior art date: 2019-11-04
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)

English (en)

Other versions

EP4055005A1 (fr

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.)

2019-11-04

Filing date

2020-11-04

Publication date

2023-11-29

2020-11-04 Application filed by Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd

2022-09-14 Publication of EP4055005A1 publication Critical patent/EP4055005A1/fr

2023-11-29 Publication of EP4055005A4 publication Critical patent/EP4055005A4/fr

Status Pending legal-status Critical Current

Links

239000007788 liquid Substances 0.000 title 1
SGDBTWWWUNNDEQ-LBPRGKRZSA-N melphalan Chemical compound OC(=O)[C@@H](N)CC1=CC=C(N(CCCl)CCCl)C=C1 SGDBTWWWUNNDEQ-LBPRGKRZSA-N 0.000 title 1
229960001924 melphalan Drugs 0.000 title 1

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, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [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

EP20886165.8A 2019-11-04 2020-11-04 Composition liquide de melphalan Pending EP4055005A4 (fr)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
IN201921044683		2019-11-04
PCT/IB2020/060334 WO2021090183A1 (fr)	2019-11-04	2020-11-04	Composition liquide de melphalan

Publications (2)

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

Family

ID=75849601

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP20886165.8A Pending EP4055005A4 (fr)	2019-11-04	2020-11-04	Composition liquide de melphalan

Country Status (2)

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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
RU2060031C1 (ru) *	1993-05-27	1996-05-20	Онкологический научный центр	Способ получения сарколизина для внутривенных инъекций

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2010138920A1 (fr) *	2009-05-29	2010-12-02	Cydex Pharmaceuticals, Inc.	Compositions injectables à base de melphalan comprenant un dérivé de cyclodextrine et leurs procédés de fabrication et d'utilisation
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
WO2017002030A1 (fr) *	2015-06-30	2017-01-05	Leiutis Pharmaceuticals Pvt Ltd	Formulations liquides stables de melphalan
WO2017085696A1 (fr) *	2015-11-20	2017-05-26	Leiutis Pharmaceuticals Pvt Ltd	Formulations parentérales de melphalan

2020
- 2020-11-04 EP EP20886165.8A patent/EP4055005A4/fr active Pending
- 2020-11-04 WO PCT/IB2020/060334 patent/WO2021090183A1/fr unknown

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
RU2060031C1 (ru) *	1993-05-27	1996-05-20	Онкологический научный центр	Способ получения сарколизина для внутривенных инъекций

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 (fr)	2022-09-14
WO2021090183A1 (fr)	2021-05-14

Legal Events

Date	Code	Title	Description
2021-05-14	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2022-08-12	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2022-08-12	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2022-09-14	17P	Request for examination filed	Effective date: 20220530
2022-09-14	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2023-02-08	DAV	Request for validation of the european patent (deleted)
2023-11-29	A4	Supplementary search report drawn up and despatched	Effective date: 20231027
2023-11-29	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

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