JP7094944B2 - ロスバスタチン及びエゼチミブを含む医薬組成物並びにその調製方法 - Google Patents

ロスバスタチン及びエゼチミブを含む医薬組成物並びにその調製方法 Download PDF

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JP7094944B2
JP7094944B2 JP2019512660A JP2019512660A JP7094944B2 JP 7094944 B2 JP7094944 B2 JP 7094944B2 JP 2019512660 A JP2019512660 A JP 2019512660A JP 2019512660 A JP2019512660 A JP 2019512660A JP 7094944 B2 JP7094944 B2 JP 7094944B2
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layer
pharmaceutically acceptable
ezetimibe
rosuvastatin
excipient
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JP2019526591A5 (enExample
JP2019526591A (ja
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アレナ・プロコポヴァ
ヤロスラヴァ・スヴォボドヴァ
オンドレイ・ダマー
ペテル・ミケシュ
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Sanofi SA
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Sanofi SA
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
JP2019512660A 2016-09-05 2017-08-31 ロスバスタチン及びエゼチミブを含む医薬組成物並びにその調製方法 Active JP7094944B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CZPV2016-539 2016-09-05
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 (3)

Publication Number Publication Date
JP2019526591A JP2019526591A (ja) 2019-09-19
JP2019526591A5 JP2019526591A5 (enExample) 2020-08-20
JP7094944B2 true JP7094944B2 (ja) 2022-07-04

Family

ID=59955311

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JP2019512660A Active JP7094944B2 (ja) 2016-09-05 2017-08-31 ロスバスタチン及びエゼチミブを含む医薬組成物並びにその調製方法

Country Status (13)

Country Link
US (1) US11786526B2 (enExample)
EP (1) EP3506888A1 (enExample)
JP (1) JP7094944B2 (enExample)
KR (1) KR102517765B1 (enExample)
CN (1) CN110418637A (enExample)
CZ (1) CZ2016539A3 (enExample)
EA (1) EA201990652A1 (enExample)
IL (1) IL265172B (enExample)
MA (1) MA46100A (enExample)
MX (1) MX389761B (enExample)
TW (1) TWI811195B (enExample)
WO (1) WO2018041282A1 (enExample)
ZA (1) ZA201901342B (enExample)

Families Citing this family (5)

* 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
WO2021019499A1 (en) 2019-07-31 2021-02-04 TECNIMEDE - Sociedade Técnico-medicinal, SA Solid oral multiple-unit immediate release compositions, methods and uses thereof
WO2022023206A1 (en) * 2020-07-27 2022-02-03 Krka, D.D., Novo Mesto Bilayer tablet comprising ezetimibe and atorvastatin
CN120000605A (zh) * 2025-04-21 2025-05-16 山东齐都药业有限公司 瑞舒伐他汀依折麦布制剂及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012504155A (ja) 2008-09-30 2012-02-16 レツク・フアーマシユーテイカルズ・デー・デー エゼチミブを含む配合物
WO2013166117A1 (en) 2012-05-01 2013-11-07 Althera Life Sciences, Llc Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
WO2015102400A1 (en) 2013-12-30 2015-07-09 Hanmi Pharm. Co., Ltd. Composite formulation for oral administration comprising ezetimibe and rosuvastatin
WO2015199356A1 (en) 2014-06-25 2015-12-30 Hanmi Pharm. Co., Ltd. Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof
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

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE60319983T2 (de) * 2003-09-01 2009-07-23 Jpm - The Jordanian Pharmaceutical Manufacturing Co. Ltd. Universelle Zusammensetzung zur kontrollierten Wirkstoffabgabe enthaltend Chitosan
WO2009024889A2 (en) 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
EP2448919A2 (en) 2009-07-02 2012-05-09 Mahmut Bilgic Solubility and stability enchancing pharmaceutical formulation
HUE038048T2 (hu) * 2009-07-28 2018-09-28 Egyt Gyogyszervegyeszeti Gyar Új granulálási eljárás és ezzel elõállított granulátum
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
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
FR3030251B1 (fr) * 2014-12-22 2018-11-02 L'oreal Composition comprenant un compose 4-(heterocycloalkyl)-benzene-1,3-diol et un solvant particulier

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012504155A (ja) 2008-09-30 2012-02-16 レツク・フアーマシユーテイカルズ・デー・デー エゼチミブを含む配合物
WO2013166117A1 (en) 2012-05-01 2013-11-07 Althera Life Sciences, Llc Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
WO2015102400A1 (en) 2013-12-30 2015-07-09 Hanmi Pharm. Co., Ltd. Composite formulation for oral administration comprising ezetimibe and rosuvastatin
WO2015199356A1 (en) 2014-06-25 2015-12-30 Hanmi Pharm. Co., Ltd. Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof
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
MA46100A (fr) 2019-07-10
TW201818938A (zh) 2018-06-01
MX2019002516A (es) 2019-06-17
TWI811195B (zh) 2023-08-11
JP2019526591A (ja) 2019-09-19
ZA201901342B (en) 2020-10-28
US20200009136A1 (en) 2020-01-09
CZ2016539A3 (cs) 2018-03-14
IL265172A (en) 2019-05-30
WO2018041282A1 (en) 2018-03-08
IL265172B (en) 2022-09-01
MX389761B (es) 2025-03-20
EA201990652A1 (ru) 2019-08-30
US11786526B2 (en) 2023-10-17
EP3506888A1 (en) 2019-07-10
CN110418637A (zh) 2019-11-05
KR20190045286A (ko) 2019-05-02
KR102517765B1 (ko) 2023-04-03
BR112019004269A2 (pt) 2019-06-04

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