BR112019004269A2 - composição farmacêutica compreendendo rosuvastatina e ezetimiba e método para sua preparação - Google Patents

composição farmacêutica compreendendo rosuvastatina e ezetimiba e método para sua preparação

Info

Publication number
BR112019004269A2
BR112019004269A2 BR112019004269A BR112019004269A BR112019004269A2 BR 112019004269 A2 BR112019004269 A2 BR 112019004269A2 BR 112019004269 A BR112019004269 A BR 112019004269A BR 112019004269 A BR112019004269 A BR 112019004269A BR 112019004269 A2 BR112019004269 A2 BR 112019004269A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
ezetimibe
rosuvastatin
fluorophenyl
preparation
Prior art date
Application number
BR112019004269A
Other languages
English (en)
Inventor
Prokopova Alena
Svobodova Jaroslava
Dammer Ondrej
Mikes Petr
Original Assignee
Sanofi Sa
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 Sanofi Sa filed Critical Sanofi Sa
Publication of BR112019004269A2 publication Critical patent/BR112019004269A2/pt

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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K31/397Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

a invenção refere-se a uma composição farmacêutica compreendendo os ingredientes ativos rosuvastatina de fórmula i, com o nome sistemático (3r, 5s, 6e) -7-[4-(4-fluorofenil)-2-(n-methylmethanesulfonamido)-6-(propano-2-il) pirimidin-5-il]-3,5-di-hidroxi-6-enco ou seus sais farmaceuticamente aceitáveis, ésteres, hidratos ou solvatos, e ezetimiba de fórmula ii, com o nome sistemático (3r, 4s)-1-(4-fluorofenil)-3-[(3s)-3-(4-fluorofenil)-3-hidroxipropil]-4-(4-hidroxifenil) azetidin-2-ona ou do seu sais, ésteres, hidratos ou solvatos farmaceuticamente aceitáveis, bem como um método de preparação da presente composição farmacêutica. a proporção em peso das camadas é de 1: 2 a 2: 1. (i), (ii).
BR112019004269A 2016-09-05 2017-08-31 composição farmacêutica compreendendo rosuvastatina e ezetimiba e método para sua preparação BR112019004269A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZ2016-539A CZ2016539A3 (cs) 2016-09-05 2016-09-05 Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy
PCT/CZ2017/050037 WO2018041282A1 (en) 2016-09-05 2017-08-31 A pharmaceutical composition comprising rosuvastatin and ezetimibe and a preparation method thereof

Publications (1)

Publication Number Publication Date
BR112019004269A2 true BR112019004269A2 (pt) 2019-06-04

Family

ID=59955311

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019004269A BR112019004269A2 (pt) 2016-09-05 2017-08-31 composição farmacêutica compreendendo rosuvastatina e ezetimiba e método para sua preparação

Country Status (14)

Country Link
US (1) US11786526B2 (pt)
EP (1) EP3506888A1 (pt)
JP (1) JP7094944B2 (pt)
KR (1) KR102517765B1 (pt)
CN (1) CN110418637A (pt)
BR (1) BR112019004269A2 (pt)
CZ (1) CZ2016539A3 (pt)
EA (1) EA201990652A1 (pt)
IL (1) IL265172B (pt)
MA (1) MA46100A (pt)
MX (1) MX2019002516A (pt)
TW (1) TWI811195B (pt)
WO (1) WO2018041282A1 (pt)
ZA (1) ZA201901342B (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7115825B2 (ja) * 2017-06-28 2022-08-09 日医工株式会社 エゼチミブ含有経口製剤及びその製造方法
JP2019014700A (ja) * 2017-07-11 2019-01-31 大原薬品工業株式会社 エゼチミブ含有口腔内崩壊錠及びその製造方法
BR112022001783A2 (pt) 2019-07-31 2022-03-22 Tecnimede Soc Tecnico Medicinal Sa Composições orais sólidas multiunitárias de liberação imediata, seus métodos e usos.
EP4188338A1 (en) * 2020-07-27 2023-06-07 KRKA, d.d., Novo mesto Bilayer tablet comprising ezetimibe and atorvastatin

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1512394B1 (en) * 2003-09-01 2008-03-26 JPM - The Jordanian Pharmaceutical Manufacturing Co. Ltd. Universal controlled-release composition comprising chitosan
WO2009024889A2 (en) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
EP2168573A1 (en) 2008-09-30 2010-03-31 LEK Pharmaceuticals D.D. Formulations comprising ezetimibe
EP2448919A2 (en) 2009-07-02 2012-05-09 Mahmut Bilgic Solubility and stability enchancing pharmaceutical formulation
EP2459175B1 (en) * 2009-07-28 2017-11-01 Egis Gyógyszergyár Zrt. New granulating process and thus prepared granulate
TR201009397A2 (tr) 2010-11-11 2012-05-21 Bi̇lgi̇ç Mahmut Rosuvastatin içeren farmasötik bileşimler.
WO2013066279A1 (en) 2011-10-13 2013-05-10 Mahmut Bilgic Solid dosage forms comprising ezetimibe
MX365046B (es) * 2012-05-01 2019-05-17 Althera Life Sciencies Llc Formulacion de tableta oral que consiste de una combinacion fija de rosuvastatina y ezetimiba para el tratamiento de hiperlipidemia y enfermedades cardiovasculares.
MX2012014970A (es) * 2012-12-18 2013-08-27 Hetlabs Mexico S A De C V Composiciones farmaceuticas que comprenden ezetimiba y rosuvastatina de calcio amorfo novedoso.
HU231036B1 (hu) * 2013-09-30 2019-12-30 Egis Gyógyszergyár Nyilvánosan Működő Részvénytársaság Koleszterin bioszintézis gátló hatóanyagot és koleszterin abszorpciót gátló hatóanyagot tartalmazó kombinációs gyógyszerkészítmény
CN103585157B (zh) * 2013-11-13 2016-02-03 武汉武药科技有限公司 一种含依折麦布和瑞舒伐他汀的双层片及其制备方法
KR20150079373A (ko) * 2013-12-30 2015-07-08 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제
KR101977785B1 (ko) 2014-06-25 2019-05-14 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법
FR3030251B1 (fr) * 2014-12-22 2018-11-02 L'oreal Composition comprenant un compose 4-(heterocycloalkyl)-benzene-1,3-diol et un solvant particulier
CN105310993A (zh) 2015-11-17 2016-02-10 深圳信立泰药业股份有限公司 一种含有依折麦布的药物组合物及其制备方法

Also Published As

Publication number Publication date
EP3506888A1 (en) 2019-07-10
ZA201901342B (en) 2020-10-28
CN110418637A (zh) 2019-11-05
JP2019526591A (ja) 2019-09-19
US20200009136A1 (en) 2020-01-09
US11786526B2 (en) 2023-10-17
JP7094944B2 (ja) 2022-07-04
KR20190045286A (ko) 2019-05-02
WO2018041282A1 (en) 2018-03-08
KR102517765B1 (ko) 2023-04-03
MX2019002516A (es) 2019-06-17
EA201990652A1 (ru) 2019-08-30
MA46100A (fr) 2019-07-10
TWI811195B (zh) 2023-08-11
IL265172B (en) 2022-09-01
TW201818938A (zh) 2018-06-01
CZ2016539A3 (cs) 2018-03-14
IL265172A (en) 2019-05-30

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]