KR102517765B1 - 로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법 - Google Patents

로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법 Download PDF

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KR102517765B1
KR102517765B1 KR1020197009428A KR20197009428A KR102517765B1 KR 102517765 B1 KR102517765 B1 KR 102517765B1 KR 1020197009428 A KR1020197009428 A KR 1020197009428A KR 20197009428 A KR20197009428 A KR 20197009428A KR 102517765 B1 KR102517765 B1 KR 102517765B1
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ezetimibe
pharmaceutically acceptable
rosuvastatin
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KR20190045286A (ko
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알레나 프로코포바
야로슬라바 스보보도바
온드레 다머
페트르 미케스
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사노피
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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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (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)
KR1020197009428A 2016-09-05 2017-08-31 로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법 Active KR102517765B1 (ko)

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 (2)

Publication Number Publication Date
KR20190045286A KR20190045286A (ko) 2019-05-02
KR102517765B1 true KR102517765B1 (ko) 2023-04-03

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KR1020197009428A Active KR102517765B1 (ko) 2016-09-05 2017-08-31 로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법

Country Status (13)

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

Families Citing this family (6)

* 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 Sociedade Tecnico Medicinal Sa Composições orais sólidas multiunitárias de liberação imediata, seus métodos e usos.
WO2022023206A1 (en) * 2020-07-27 2022-02-03 Krka, D.D., Novo Mesto Bilayer tablet comprising ezetimibe and atorvastatin
JP2022104836A (ja) * 2020-12-29 2022-07-11 日本ジェネリック株式会社 エゼチミブ及びロスバスタチンを含む錠剤
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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009024889A2 (en) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
US20140287042A1 (en) * 2012-05-01 2014-09-25 Althera Life Sciences Llc Oral Tablet Formulation Consisting Of Fixed Combination Of Rosuvastatin And Ezetimibe For Treatment Of Hyperlipidemia And Cardiovascular Diseases
WO2015044698A2 (en) * 2013-09-30 2015-04-02 Egis Gyógyszergyár Zrt. Medical composition containing a cholesterol absorption inhibitor and cholesterol biosynthesis inhibitor

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE390127T1 (de) * 2003-09-01 2008-04-15 Jpm The Jordanian Pharmaceutic Universelle zusammensetzung zur kontrollierten wirkstoffabgabe enthaltend chitosan
EP2168573A1 (en) 2008-09-30 2010-03-31 LEK Pharmaceuticals D.D. Formulations comprising ezetimibe
WO2011019326A2 (en) 2009-07-02 2011-02-17 Mahmut Bilgic Solubility and stability enchancing pharmaceutical formulation
PT2459175T (pt) * 2009-07-28 2018-02-07 Egyt Gyogyszervegyeszeti Gyar Novo processo de granulação e o granulado assim preparado
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.
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009024889A2 (en) * 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
US20140287042A1 (en) * 2012-05-01 2014-09-25 Althera Life Sciences Llc Oral Tablet Formulation Consisting Of Fixed Combination Of Rosuvastatin And Ezetimibe For Treatment Of Hyperlipidemia And Cardiovascular Diseases
WO2015044698A2 (en) * 2013-09-30 2015-04-02 Egis Gyógyszergyár Zrt. Medical composition containing a cholesterol absorption inhibitor and cholesterol biosynthesis inhibitor

Also Published As

Publication number Publication date
WO2018041282A1 (en) 2018-03-08
US20200009136A1 (en) 2020-01-09
MA46100A (fr) 2019-07-10
MX389761B (es) 2025-03-20
MX2019002516A (es) 2019-06-17
IL265172A (en) 2019-05-30
KR20190045286A (ko) 2019-05-02
JP7094944B2 (ja) 2022-07-04
JP2019526591A (ja) 2019-09-19
CN110418637A (zh) 2019-11-05
EA201990652A1 (ru) 2019-08-30
EP3506888A1 (en) 2019-07-10
BR112019004269A2 (pt) 2019-06-04
IL265172B (en) 2022-09-01
ZA201901342B (en) 2020-10-28
TWI811195B (zh) 2023-08-11
US11786526B2 (en) 2023-10-17
CZ2016539A3 (cs) 2018-03-14
TW201818938A (zh) 2018-06-01

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