EA202090398A1 - Фармацевтическая композиция, включающая сакубитрил и валсартан - Google Patents

Фармацевтическая композиция, включающая сакубитрил и валсартан

Info

Publication number
EA202090398A1
EA202090398A1 EA202090398A EA202090398A EA202090398A1 EA 202090398 A1 EA202090398 A1 EA 202090398A1 EA 202090398 A EA202090398 A EA 202090398A EA 202090398 A EA202090398 A EA 202090398A EA 202090398 A1 EA202090398 A1 EA 202090398A1
Authority
EA
Eurasian Patent Office
Prior art keywords
pharmaceutical composition
valsartan
sakubitril
relates
present
Prior art date
Application number
EA202090398A
Other languages
English (en)
Inventor
Бохумил Димацек
Марта Виванкос Мартинес
Луис Ногейрас Ньето
Лисардо Альварес Фернандес
Рохит Кумар
Хосе Велада Кальсада
Петр Миташ
Original Assignee
Синтон Б.В.
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 Синтон Б.В. filed Critical Синтон Б.В.
Publication of EA202090398A1 publication Critical patent/EA202090398A1/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D257/00Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms
    • C07D257/02Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms not condensed with other rings
    • C07D257/04Five-membered rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Abstract

Настоящее изобретение относится к фармацевтической композиции, включающей физическую смесь натриевой соли сакубитрила и динатриевой соли валсартана, где порошковая рентгеновская дифрактограмма динатриевой соли валсартана включает характеристические пики при следующих углах 2 тета (0,2): 4,70, 9,29, 22,34°, измеренные с использованием излучения Cu K. Настоящее изобретение также относится к применению указанной фармацевтической композиции в качестве лекарственного средства для лечения сердечной недостаточности.
EA202090398A 2017-07-28 2018-07-25 Фармацевтическая композиция, включающая сакубитрил и валсартан EA202090398A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17183859 2017-07-28
PCT/EP2018/070212 WO2019020706A1 (en) 2017-07-28 2018-07-25 PHARMACEUTICAL COMPOSITION COMPRISING SACUBITRIL AND VALSARTAN

Publications (1)

Publication Number Publication Date
EA202090398A1 true EA202090398A1 (ru) 2020-05-15

Family

ID=59501295

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202090398A EA202090398A1 (ru) 2017-07-28 2018-07-25 Фармацевтическая композиция, включающая сакубитрил и валсартан

Country Status (6)

Country Link
US (1) US10588892B2 (ru)
EP (1) EP3658122B1 (ru)
EA (1) EA202090398A1 (ru)
ES (1) ES2881317T3 (ru)
PL (1) PL3658122T3 (ru)
WO (1) WO2019020706A1 (ru)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018040065A1 (zh) * 2016-09-02 2018-03-08 诺瑞特国际药业股份有限公司 缬沙坦二钠盐的晶型
EP4088715A1 (en) 2021-05-14 2022-11-16 KRKA, d.d., Novo mesto Pharmaceutical formulation of valsartan and sacubitril
WO2023211412A1 (en) * 2022-04-26 2023-11-02 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi A tablet comprising sacubitril and valsartan processed with dry granulation
EP4268806A3 (en) * 2022-04-26 2023-12-27 Sanovel Ilac Sanayi Ve Ticaret A.S. A tablet comprising sacubitril and valsartan processed with dry granulation

Family Cites Families (16)

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Publication number Priority date Publication date Assignee Title
ATE134624T1 (de) 1990-02-19 1996-03-15 Ciba Geigy Ag Acylverbindungen
WO1992013564A1 (en) 1991-02-06 1992-08-20 Schering Corporation Combination of an angiotensin ii antagonist or renin inhibitor with a neutral endopeptidase inhibitor
US5217996A (en) 1992-01-22 1993-06-08 Ciba-Geigy Corporation Biaryl substituted 4-amino-butyric acid amides
CA2168066A1 (en) 1995-02-08 1996-08-09 James R. Powell Treatment of hypertension and congestive heart failure
US6204281B1 (en) 1998-07-10 2001-03-20 Novartis Ag Method of treatment and pharmaceutical composition
AR032758A1 (es) 2000-07-19 2003-11-26 Novartis Ag Sales valsartan, un proceso para su fabricacion, composiciones farmaceuticas y el uso de dichas sales para la preparacion de medicamentos
US7468390B2 (en) 2002-01-17 2008-12-23 Novartis Ag Methods of treatment and pharmaceutical composition
BR122018015003B8 (pt) 2002-01-17 2021-07-27 Novartis Ag kit compreendendo composições farmacêuticas de inibidor da nep e de valsartan ou seus sais
AR057882A1 (es) 2005-11-09 2007-12-26 Novartis Ag Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra
CA2703598C (en) 2007-11-06 2016-08-09 Novartis Ag Dual-acting pharmaceutical compositions based on superstructures of angiotensin receptor antagonist/blocker (arb) and neutral endopeptidase (nep) inhibitor
WO2013181455A1 (en) * 2012-05-30 2013-12-05 Robert Gellibolian Water bottle with flow meter
CN105837464A (zh) 2015-01-15 2016-08-10 四川海思科制药有限公司 沙库比曲钠的晶型及其制备方法和用途
KR20200117037A (ko) * 2015-06-12 2020-10-13 테바 파마슈티컬스 인터내셔널 게엠베하 삼나트륨 발사르탄:사쿠비트릴의 고체 형태
WO2017012600A1 (en) 2015-07-20 2017-01-26 Zentiva, K.S. A pharmaceutical composition containing valsartan and sacubitril and methods for preparation and stabilization thereof
EP3386945A1 (en) * 2015-12-11 2018-10-17 Zentiva, K.S. Solid forms of (2r,4s)-5-(biphenyl-4-yl)-4-[(3-carboxypropionyl)amino]-2- -methylpentanoic acid ethyl ester, its salts and a preparation method
US10722471B2 (en) * 2016-02-03 2020-07-28 Novartis Ag Galenic formulations of organic compounds

Also Published As

Publication number Publication date
EP3658122B1 (en) 2021-04-07
EP3658122A1 (en) 2020-06-03
PL3658122T3 (pl) 2021-10-18
US20190030000A1 (en) 2019-01-31
WO2019020706A1 (en) 2019-01-31
ES2881317T3 (es) 2021-11-29
US10588892B2 (en) 2020-03-17

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