TWI811195B - 包含兩種不同活性原料的醫藥組成物及其製備方法 - Google Patents

包含兩種不同活性原料的醫藥組成物及其製備方法 Download PDF

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Publication number
TWI811195B
TWI811195B TW106129702A TW106129702A TWI811195B TW I811195 B TWI811195 B TW I811195B TW 106129702 A TW106129702 A TW 106129702A TW 106129702 A TW106129702 A TW 106129702A TW I811195 B TWI811195 B TW I811195B
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TW
Taiwan
Prior art keywords
layer
ezetimibe
pharmaceutically acceptable
group
double
Prior art date
Application number
TW106129702A
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English (en)
Chinese (zh)
Other versions
TW201818938A (zh
Inventor
阿蓮娜 波可波娃
尹羅斯拉夫拉 斯夫波多娃
安德烈 達門
彼特 麥克斯
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法商賽諾菲
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Publication of TW201818938A publication Critical patent/TW201818938A/zh
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Publication of TWI811195B publication Critical patent/TWI811195B/zh

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    • 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
    • A61K9/2072—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
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Obesity (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)
TW106129702A 2016-09-05 2017-08-31 包含兩種不同活性原料的醫藥組成物及其製備方法 TWI811195B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZPV-2016-539 2016-09-05
CZ2016-539A CZ2016539A3 (cs) 2016-09-05 2016-09-05 Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy

Publications (2)

Publication Number Publication Date
TW201818938A TW201818938A (zh) 2018-06-01
TWI811195B true TWI811195B (zh) 2023-08-11

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
TW106129702A TWI811195B (zh) 2016-09-05 2017-08-31 包含兩種不同活性原料的醫藥組成物及其製備方法

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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
TW201625223A (zh) * 2014-06-25 2016-07-16 韓美藥品股份有限公司 用於口服投藥之包含依澤替米貝（ｅｚｅｔｉｍｉｂｅ）及羅舒伐他汀（ｒｏｓｕｖａｓｔａｔｉｎ）的複合調配物及其製備方法

Family Cites Families (13)

* 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
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
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
KR20150079373A (ko) * 2013-12-30 2015-07-08 한미약품 주식회사 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제
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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
TW201625223A (zh) * 2014-06-25 2016-07-16 韓美藥品股份有限公司 用於口服投藥之包含依澤替米貝（ｅｚｅｔｉｍｉｂｅ）及羅舒伐他汀（ｒｏｓｕｖａｓｔａｔｉｎ）的複合調配物及其製備方法

Also Published As

Publication number Publication date
MA46100A (fr) 2019-07-10
TW201818938A (zh) 2018-06-01
MX2019002516A (es) 2019-06-17
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
JP7094944B2 (ja) 2022-07-04
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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