KR102517765B1 - 로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법 - Google Patents
로수바스타틴 및 에제티미브를 포함하는 제약 조성물 및 그의 제조 방법 Download PDFInfo
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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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- South Korea
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- ezetimibe
- pharmaceutically acceptable
- rosuvastatin
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- YYRMJZQKEFZXMX-UHFFFAOYSA-L calcium bis(dihydrogenphosphate) Chemical compound [Ca+2].OP(O)([O-])=O.OP(O)([O-])=O YYRMJZQKEFZXMX-UHFFFAOYSA-L 0.000 description 1
- 235000011116 calcium hydroxide Nutrition 0.000 description 1
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- 239000010949 copper Substances 0.000 description 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
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- 201000010099 disease Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- GVGUFUZHNYFZLC-UHFFFAOYSA-N dodecyl benzenesulfonate;sodium Chemical compound [Na].CCCCCCCCCCCCOS(=O)(=O)C1=CC=CC=C1 GVGUFUZHNYFZLC-UHFFFAOYSA-N 0.000 description 1
- QZUNHWGQSGFRAR-UHFFFAOYSA-N dodecyl octadecanoate;sodium Chemical compound [Na].CCCCCCCCCCCCCCCCCC(=O)OCCCCCCCCCCCC QZUNHWGQSGFRAR-UHFFFAOYSA-N 0.000 description 1
- 239000003974 emollient agent Substances 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
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- 150000004677 hydrates Chemical class 0.000 description 1
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- 239000003112 inhibitor Substances 0.000 description 1
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- 230000007774 longterm Effects 0.000 description 1
- 159000000003 magnesium salts Chemical class 0.000 description 1
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- 239000002075 main ingredient Substances 0.000 description 1
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- 239000011572 manganese Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229960003194 meglumine Drugs 0.000 description 1
- 235000019691 monocalcium phosphate Nutrition 0.000 description 1
- 125000006353 oxyethylene group Chemical group 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 235000021317 phosphate Nutrition 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 239000005871 repellent Substances 0.000 description 1
- 230000002940 repellent Effects 0.000 description 1
- 238000012776 robust process Methods 0.000 description 1
- 238000000790 scattering method Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229960002855 simvastatin Drugs 0.000 description 1
- RYMZZMVNJRMUDD-HGQWONQESA-N simvastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)C(C)(C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 RYMZZMVNJRMUDD-HGQWONQESA-N 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 229940080264 sodium dodecylbenzenesulfonate Drugs 0.000 description 1
- NWZBFJYXRGSRGD-UHFFFAOYSA-M sodium;octadecyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCCCOS([O-])(=O)=O NWZBFJYXRGSRGD-UHFFFAOYSA-M 0.000 description 1
- 238000012430 stability testing Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Images
Classifications
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- 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
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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
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
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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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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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
- A61K9/2004—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
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- 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
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- 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)
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- 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)
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)
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| KR20190045286A KR20190045286A (ko) | 2019-05-02 |
| KR102517765B1 true KR102517765B1 (ko) | 2023-04-03 |
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| EP (1) | EP3506888A1 (enExample) |
| JP (1) | JP7094944B2 (enExample) |
| KR (1) | KR102517765B1 (enExample) |
| CN (1) | CN110418637A (enExample) |
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| MA (1) | MA46100A (enExample) |
| MX (1) | MX389761B (enExample) |
| TW (1) | TWI811195B (enExample) |
| WO (1) | WO2018041282A1 (enExample) |
| ZA (1) | ZA201901342B (enExample) |
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| 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 (3)
| 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)
| 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 |
| 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. |
| 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 |
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2016
- 2016-09-05 CZ CZ2016-539A patent/CZ2016539A3/cs unknown
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2017
- 2017-08-31 CN CN201780067887.8A patent/CN110418637A/zh active Pending
- 2017-08-31 TW TW106129702A patent/TWI811195B/zh active
- 2017-08-31 IL IL265172A patent/IL265172B/en unknown
- 2017-08-31 US US16/330,268 patent/US11786526B2/en active Active
- 2017-08-31 EA EA201990652A patent/EA201990652A1/ru unknown
- 2017-08-31 EP EP17771980.4A patent/EP3506888A1/en active Pending
- 2017-08-31 JP JP2019512660A patent/JP7094944B2/ja active Active
- 2017-08-31 MX MX2019002516A patent/MX389761B/es unknown
- 2017-08-31 MA MA046100A patent/MA46100A/fr unknown
- 2017-08-31 KR KR1020197009428A patent/KR102517765B1/ko active Active
- 2017-08-31 WO PCT/CZ2017/050037 patent/WO2018041282A1/en not_active Ceased
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2019
- 2019-03-04 ZA ZA2019/01342A patent/ZA201901342B/en unknown
Patent Citations (3)
| 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 |
|---|---|
| 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 |
| 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 |
| BR112019004269A2 (pt) | 2019-06-04 |
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