AR100977A1 - Formulación compuesta para la administración oral que comprende ezetimiba y rosuvastatina, y un proceso para su preparación - Google Patents
Formulación compuesta para la administración oral que comprende ezetimiba y rosuvastatina, y un proceso para su preparaciónInfo
- Publication number
- AR100977A1 AR100977A1 ARP150102016A ARP150102016A AR100977A1 AR 100977 A1 AR100977 A1 AR 100977A1 AR P150102016 A ARP150102016 A AR P150102016A AR P150102016 A ARP150102016 A AR P150102016A AR 100977 A1 AR100977 A1 AR 100977A1
- Authority
- AR
- Argentina
- Prior art keywords
- rosuvastatin
- portion corresponding
- ezetimibe
- composite formulation
- mixture
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 14
- OLNTVTPDXPETLC-XPWALMASSA-N ezetimibe Chemical compound N1([C@@H]([C@H](C1=O)CC[C@H](O)C=1C=CC(F)=CC=1)C=1C=CC(O)=CC=1)C1=CC=C(F)C=C1 OLNTVTPDXPETLC-XPWALMASSA-N 0.000 title abstract 9
- 238000009472 formulation Methods 0.000 title abstract 9
- BPRHUIZQVSMCRT-VEUZHWNKSA-N rosuvastatin Chemical compound CC(C)C1=NC(N(C)S(C)(=O)=O)=NC(C=2C=CC(F)=CC=2)=C1\C=C\[C@@H](O)C[C@@H](O)CC(O)=O BPRHUIZQVSMCRT-VEUZHWNKSA-N 0.000 title abstract 9
- 229960000672 rosuvastatin Drugs 0.000 title abstract 9
- 239000002131 composite material Substances 0.000 title abstract 8
- 238000000034 method Methods 0.000 title abstract 3
- 229960000815 ezetimibe Drugs 0.000 abstract 8
- 239000007787 solid Substances 0.000 abstract 7
- 239000008187 granular material Substances 0.000 abstract 6
- 150000003839 salts Chemical class 0.000 abstract 3
- 239000003826 tablet Substances 0.000 abstract 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 abstract 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 2
- 239000002552 dosage form Substances 0.000 abstract 2
- 239000012530 fluid Substances 0.000 abstract 2
- 239000008101 lactose Substances 0.000 abstract 2
- 229960001375 lactose Drugs 0.000 abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 2
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 2
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 2
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 abstract 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- 239000011230 binding agent Substances 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 229960001681 croscarmellose sodium Drugs 0.000 abstract 1
- 229960000913 crospovidone Drugs 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- 239000003085 diluting agent Substances 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 239000010410 layer Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 229940057948 magnesium stearate Drugs 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 229960001855 mannitol Drugs 0.000 abstract 1
- 239000008188 pellet Substances 0.000 abstract 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 229940069328 povidone Drugs 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 239000002356 single layer Substances 0.000 abstract 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 abstract 1
Classifications
-
- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (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)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Una formulación compuesta sólida para la administración oral que incluye: una porción correspondiente a gránulos húmedos de ezetimiba que incluye ezetimiba que se granula por vía húmeda utilizando un granulador de lecho fluido; y una porción correspondiente a una mezcla de rosuvastatina que incluye rosuvastatina o una de sus sales farmacéuticamente aceptables. Reivindicación 5: La formulación compuesta sólida de la reivindicación 1, donde la porción correspondiente a gránulos húmedos de ezetimiba o la porción correspondiente a una mezcla de rosuvastatina comprende además al menos un aditivo farmacéuticamente aceptable seleccionado del grupo constituido por un diluyente, un aglutinante, un desintegrante y un lubricante. Reivindicación 7: La formulación compuesta sólida de la reivindicación 1, donde la porción correspondiente a gránulos húmedos de ezetimiba comprende lactosa, celulosa microcristalina, laurilsulfato de sodio, povidona y croscarmelosa sódica, y la porción correspondiente a una mezcla de rosuvastatina comprende celulosa microcristalina, lactosa, manitol, crospovidona y estearato de magnesio. Reivindicación 8: La formulación compuesta sólida de la reivindicación 1, donde la cantidad de ezetimiba esté comprendida dentro de un rango de aproximadamente 5 mg a aproximadamente 20 mg en una forma farmacéutica unitaria. Reivindicación 9: La formulación compuesta sólida de la reivindicación 1 donde la cantidad de rosuvastatina o una de sus sales farmacéuticamente aceptables está comprendida dentro de un rango de aproximadamente 2.5 mg a aproximadamente 40 mg en una forma farmacéutica unitaria. Reivindicación 10: La formulación compuesta sólida de la reivindicación 1, donde la formulación compuesta está en forma de un pellet, una cápsula, un comprimido de una única capa, un comprimido de dos capas, un comprimido recubierto a presión, polvo o gránulos. Reivindicación 12: Un método de preparación de la formulación compuesta sólida para la administración oral de acuerdo con cualquiera de las reivindicaciones 1 - 11, comprendiendo el método: preparar una porción correspondiente a gránulos húmedos de ezetimiba que comprenda ezetimiba utilizando un granulador de lecho fluido; y formular la porción correspondiente a gránulos húmedos de ezetimiba y una porción correspondiente a una mezcla de rosuvastatina juntas, donde la porción correspondiente a una mezcla de rosuvastatina comprende rosuvastatina o una de sus sales farmacéuticamente aceptables.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020140078388A KR101977785B1 (ko) | 2014-06-25 | 2014-06-25 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합제제 및 그 제조방법 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR100977A1 true AR100977A1 (es) | 2016-11-16 |
Family
ID=54938391
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150102016A AR100977A1 (es) | 2014-06-25 | 2015-06-24 | Formulación compuesta para la administración oral que comprende ezetimiba y rosuvastatina, y un proceso para su preparación |
Country Status (10)
| Country | Link |
|---|---|
| KR (1) | KR101977785B1 (es) |
| AR (1) | AR100977A1 (es) |
| BR (1) | BR112016030111A2 (es) |
| CL (1) | CL2016003283A1 (es) |
| EC (1) | ECSP16096477A (es) |
| JO (1) | JOP20150154B1 (es) |
| SG (2) | SG11201610748RA (es) |
| TW (1) | TWI700100B (es) |
| UY (1) | UY36190A (es) |
| WO (1) | WO2015199356A1 (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ2016538A3 (cs) | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | Farmaceutická kompozice obsahující dvě rozdílné účinné látky |
| CZ2016539A3 (cs) * | 2016-09-05 | 2018-03-14 | Zentiva, K.S. | Farmaceutická kompozice obsahující dvě rozdílné účinné látky a způsob její přípravy |
| KR102206535B1 (ko) * | 2016-11-29 | 2021-01-22 | 한미약품 주식회사 | 에제티미브 및 로수바스타틴을 포함하는 경구용 복합정제 |
| EP3437636A1 (en) * | 2017-08-02 | 2019-02-06 | Adamed sp. z o.o. | Pharmaceutical composition comprising ezetimibe |
| KR102500643B1 (ko) * | 2019-04-18 | 2023-02-16 | 한미약품 주식회사 | 에제티미브 및 로사르탄을 포함하는 약제학적 복합제제 |
| KR20200137243A (ko) | 2019-05-29 | 2020-12-09 | 콜마파마(주) | 로수바스타틴 및 에제티미브를 포함하는 복합제의 제조방법 |
| BR112022001783A2 (pt) | 2019-07-31 | 2022-03-22 | Tecnimede Sociedade Tecnico Medicinal Sa | Composições orais sólidas multiunitárias de liberação imediata, seus métodos e usos. |
| MX2023002403A (es) * | 2020-08-25 | 2023-03-22 | Daewoong Pharmaceutical Co Ltd | Composicion farmaceutica en forma de dosificacion individual para tratar o prevenir hipertension e hipercolesterolemia. |
| KR20250096941A (ko) | 2023-12-20 | 2025-06-30 | 안국약품 주식회사 | 피타바스타틴 및 에제티미브를 포함하는 단일 정제 형태의 약학 조성물 및 이의 제조방법 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100907144B1 (ko) * | 2007-09-05 | 2009-07-09 | 박재섭 | 이동부재를 이용한 골프 클럽 |
| 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 |
| US8927021B2 (en) * | 2009-07-28 | 2015-01-06 | Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszventarsasag | Granulating process and thus prepared granulate |
| EP2468258A1 (en) * | 2010-12-22 | 2012-06-27 | LEK Pharmaceuticals d.d. | Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient |
| US9763885B2 (en) * | 2012-05-01 | 2017-09-19 | Althera Laboratories Ltd. | Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases |
-
2014
- 2014-06-25 KR KR1020140078388A patent/KR101977785B1/ko active Active
-
2015
- 2015-06-09 SG SG11201610748RA patent/SG11201610748RA/en unknown
- 2015-06-09 WO PCT/KR2015/005779 patent/WO2015199356A1/en not_active Ceased
- 2015-06-09 BR BR112016030111A patent/BR112016030111A2/pt not_active Application Discontinuation
- 2015-06-09 SG SG10201811586YA patent/SG10201811586YA/en unknown
- 2015-06-16 TW TW104119406A patent/TWI700100B/zh active
- 2015-06-24 UY UY0001036190A patent/UY36190A/es not_active Application Discontinuation
- 2015-06-24 AR ARP150102016A patent/AR100977A1/es not_active Application Discontinuation
- 2015-06-24 JO JOP/2015/0154A patent/JOP20150154B1/ar active
-
2016
- 2016-12-21 CL CL2016003283A patent/CL2016003283A1/es unknown
- 2016-12-23 EC ECIEPI201696477A patent/ECSP16096477A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| SG10201811586YA (en) | 2019-02-27 |
| KR101977785B1 (ko) | 2019-05-14 |
| CL2016003283A1 (es) | 2017-07-28 |
| WO2015199356A1 (en) | 2015-12-30 |
| TW201625223A (zh) | 2016-07-16 |
| UY36190A (es) | 2015-10-30 |
| BR112016030111A2 (pt) | 2017-08-22 |
| SG11201610748RA (en) | 2017-01-27 |
| ECSP16096477A (es) | 2017-01-31 |
| KR20160000762A (ko) | 2016-01-05 |
| TWI700100B (zh) | 2020-08-01 |
| JOP20150154B1 (ar) | 2021-08-17 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |