RU2018126354A - Фармацевтический комбинированный состав - Google Patents
Фармацевтический комбинированный состав Download PDFInfo
- Publication number
- RU2018126354A RU2018126354A RU2018126354A RU2018126354A RU2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A RU 2018126354 A RU2018126354 A RU 2018126354A
- Authority
- RU
- Russia
- Prior art keywords
- tablet
- layer
- candesartan
- hydroxystearate
- macrogol
- Prior art date
Links
- GHOSNRCGJFBJIB-UHFFFAOYSA-N Candesartan cilexetil Chemical compound C=12N(CC=3C=CC(=CC=3)C=3C(=CC=CC=3)C3=NNN=N3)C(OCC)=NC2=CC=CC=1C(=O)OC(C)OC(=O)OC1CCCCC1 GHOSNRCGJFBJIB-UHFFFAOYSA-N 0.000 claims 7
- 239000010410 layer Substances 0.000 claims 6
- 229960004349 candesartan cilexetil Drugs 0.000 claims 4
- 239000002053 C09CA06 - Candesartan Substances 0.000 claims 3
- 239000004480 active ingredient Substances 0.000 claims 3
- 229960000932 candesartan Drugs 0.000 claims 3
- 229940072106 hydroxystearate Drugs 0.000 claims 3
- HTIQEAQVCYTUBX-UHFFFAOYSA-N amlodipine Chemical compound CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl HTIQEAQVCYTUBX-UHFFFAOYSA-N 0.000 claims 2
- 229960000528 amlodipine Drugs 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000002356 single layer Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 150000005846 sugar alcohols Chemical class 0.000 claims 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
- A61K9/2004—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
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (8)
1. Таблетка, содержащая кандесартан или кандесартана цилексетил в качестве первого активного ингредиента и амлодипин или его фармацевтически приемлемую соль в качестве второго активного ингредиента, отличающаяся тем, что она содержит макрогол-15-гидроксистеарат в качестве солюбилизатора.
2. Таблетка по п. 1, где первый активный ингредиент представляет собой кандесартана цилексетил.
3. Таблетка по п. 1, где она не содержит какого-либо сахарного спирта.
4. Таблетка по п. 1, где весовое соотношение кандесартана или кандесартана цилексетила и макрогол-15-гидроксистеарата составляет 1:0,03-1:2.
5. Таблетка по п. 1, где она представляет собой однослойную таблетку, многослойную таблетку или ядросодержащую таблетку.
6. Таблетка по п. 5, где многослойная таблетка представляет собой двухслойную таблетку.
7. Таблетка по п. 6, где двухслойная таблетка состоит из первого слоя и второго слоя, при этом первый слой содержит кандесартан или кандесартана цилексетил и макрогол-15-гидроксистеарат, и второй слой содержит амлодипин или его фармацевтически приемлемую соль.
8. Таблетка по п. 1, где период ее хранения составляет от 6 недель до 3 лет.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2015-0187679 | 2015-12-28 | ||
| KR1020150187679A KR101710441B1 (ko) | 2015-12-28 | 2015-12-28 | 안정성 및 용출성이 향상된 정제 |
| PCT/KR2016/015439 WO2017116150A1 (ko) | 2015-12-28 | 2016-12-28 | 약제학적 복합제제 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018126354A true RU2018126354A (ru) | 2020-01-31 |
| RU2018126354A3 RU2018126354A3 (ru) | 2020-05-12 |
| RU2736942C2 RU2736942C2 (ru) | 2020-11-23 |
Family
ID=58543052
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018126354A RU2736942C2 (ru) | 2015-12-28 | 2016-12-28 | Фармацевтический комбинированный состав |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20190015339A1 (ru) |
| EP (1) | EP3398589B1 (ru) |
| JP (1) | JP6797924B2 (ru) |
| KR (1) | KR101710441B1 (ru) |
| CN (1) | CN108472257B (ru) |
| CA (1) | CA3009468C (ru) |
| CO (1) | CO2018007821A2 (ru) |
| ES (1) | ES2868602T3 (ru) |
| MX (1) | MX383201B (ru) |
| MY (1) | MY194591A (ru) |
| PE (1) | PE20181374A1 (ru) |
| PH (1) | PH12018501392A1 (ru) |
| RU (1) | RU2736942C2 (ru) |
| WO (1) | WO2017116150A1 (ru) |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6294192B1 (en) * | 1999-02-26 | 2001-09-25 | Lipocine, Inc. | Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents |
| ITMI20012366A1 (it) * | 2001-11-09 | 2003-05-09 | Farmatron Ltd | Sistemi terapeutici stabilizzati a rilascio immediato e/o modificato per la somministrazione orale di principi attivi e/o eccipienti e/o ali |
| WO2005084648A1 (en) | 2004-02-27 | 2005-09-15 | Ranbaxy Laboratories Limited | Pharmaceutical compositions comprising candesartan cilexetil |
| PT1814527E (pt) * | 2004-11-05 | 2014-01-16 | Boehringer Ingelheim Int | Comprimido de bicamada compreendendo telmisartan e amlodipina |
| GB0600709D0 (en) | 2006-01-13 | 2006-02-22 | Portela & Ca Sa | Drug combinations |
| EP2063888A4 (en) * | 2006-09-05 | 2009-11-04 | Astrazeneca Ab | PHARMACEUTICAL COMPOSITION COMPRISING CANDESARTAN CILEXETIL |
| KR100888131B1 (ko) * | 2006-10-10 | 2009-03-11 | 한올제약주식회사 | 시간차 투약 원리를 이용한 심혈관계 질환 치료용 복합제제 |
| KR101247583B1 (ko) * | 2006-12-08 | 2013-03-26 | 한미사이언스 주식회사 | 암로디핀 또는 이의 약제학적 허용가능한 염, 및 로자탄또는 이의 약제학적 허용가능한 염을 함유하는 약제학적조성물 |
| PT2165702E (pt) * | 2008-09-17 | 2012-02-07 | Helm Ag | Composições estáveis e rapidamente dissolvidas de candesartan cilexetil preparadas com granulação húmida |
| KR20100048137A (ko) * | 2008-10-30 | 2010-05-11 | 현대약품 주식회사 | 혈압 강하용 약학 조성물 |
| DE102008059206A1 (de) | 2008-11-27 | 2010-06-10 | Bayer Schering Pharma Aktiengesellschaft | Pharmazeutische Darreichungsform enthaltend Nifedipin oder Nisoldipin und einen Angiotensin-II Antagonisten und/oder ein Diuretikum |
| KR20090065510A (ko) * | 2009-03-13 | 2009-06-22 | 다이이찌 산쿄 가부시키가이샤 | 올메사탄 메독소밀 및 암로디핀의 고형 투여 제형 |
| KR20120096920A (ko) | 2009-06-26 | 2012-08-31 | 데이진 화-마 가부시키가이샤 | 고혈압증 또는 정상 고치 혈압증의 치료약 |
| KR101171375B1 (ko) * | 2010-01-20 | 2012-08-13 | 한올바이오파마주식회사 | 난용성 약물을 함유하는 경구 제형 |
| CN101966181A (zh) * | 2010-07-08 | 2011-02-09 | 王丽燕 | 包含坎地沙坦和氨氯地平的口服固体制剂及其新应用 |
| KR101168136B1 (ko) * | 2011-08-08 | 2012-07-24 | 보령제약 주식회사 | 혈압 강하용 약제학적 조성물 |
| CN102349902B (zh) * | 2011-08-19 | 2013-05-01 | 海南锦瑞制药股份有限公司 | 一种含有左旋氨氯地平和坎地沙坦酯的药物组合物及其制备方法 |
| CN102688236B (zh) * | 2012-06-06 | 2014-03-26 | 石药集团中诺药业（石家庄）有限公司 | 一种坎地沙坦酯氨氯地平片剂组合物及其制备方法 |
| KR101302883B1 (ko) * | 2012-07-23 | 2013-09-05 | 삼일제약주식회사 | 텔미사르탄을 유효성분으로 포함하는 안정성이 증가된 약제학적 조성물 및 그 제조방법 |
| MX351059B (es) * | 2012-08-17 | 2017-09-29 | Laboratorios Senosiain S A De C V Star | Composicion farmaceutica oral en forma de microesferas y proceso de elaboracion. |
| PL236001B1 (pl) * | 2012-12-21 | 2020-11-30 | Adamed Spolka Z Ograniczona Odpowiedzialnoscia | Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję |
-
2015
- 2015-12-28 KR KR1020150187679A patent/KR101710441B1/ko active Active
-
2016
- 2016-12-28 US US16/066,712 patent/US20190015339A1/en not_active Abandoned
- 2016-12-28 CN CN201680076678.5A patent/CN108472257B/zh active Active
- 2016-12-28 PE PE2018001203A patent/PE20181374A1/es unknown
- 2016-12-28 MX MX2018007976A patent/MX383201B/es unknown
- 2016-12-28 JP JP2018534575A patent/JP6797924B2/ja active Active
- 2016-12-28 EP EP16882102.3A patent/EP3398589B1/en active Active
- 2016-12-28 CA CA3009468A patent/CA3009468C/en active Active
- 2016-12-28 MY MYPI2018001138A patent/MY194591A/en unknown
- 2016-12-28 ES ES16882102T patent/ES2868602T3/es active Active
- 2016-12-28 RU RU2018126354A patent/RU2736942C2/ru active
- 2016-12-28 WO PCT/KR2016/015439 patent/WO2017116150A1/ko not_active Ceased
-
2018
- 2018-06-28 PH PH12018501392A patent/PH12018501392A1/en unknown
- 2018-07-27 CO CONC2018/0007821A patent/CO2018007821A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PH12018501392A1 (en) | 2019-02-27 |
| CN108472257B (zh) | 2020-12-04 |
| RU2736942C2 (ru) | 2020-11-23 |
| CA3009468A1 (en) | 2017-07-06 |
| EP3398589B1 (en) | 2021-01-27 |
| BR112018013121A2 (pt) | 2018-12-11 |
| WO2017116150A1 (ko) | 2017-07-06 |
| CO2018007821A2 (es) | 2018-08-10 |
| ES2868602T3 (es) | 2021-10-21 |
| JP6797924B2 (ja) | 2020-12-09 |
| MX2018007976A (es) | 2019-03-28 |
| RU2018126354A3 (ru) | 2020-05-12 |
| CA3009468C (en) | 2024-06-25 |
| CN108472257A (zh) | 2018-08-31 |
| MX383201B (es) | 2025-03-13 |
| EP3398589A4 (en) | 2019-08-28 |
| MY194591A (en) | 2022-12-05 |
| EP3398589A1 (en) | 2018-11-07 |
| JP2019500392A (ja) | 2019-01-10 |
| US20190015339A1 (en) | 2019-01-17 |
| PE20181374A1 (es) | 2018-08-28 |
| KR101710441B1 (ko) | 2017-02-28 |
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