JP2009504744A5 - - Google Patents
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- Publication number
- JP2009504744A5 JP2009504744A5 JP2008527038A JP2008527038A JP2009504744A5 JP 2009504744 A5 JP2009504744 A5 JP 2009504744A5 JP 2008527038 A JP2008527038 A JP 2008527038A JP 2008527038 A JP2008527038 A JP 2008527038A JP 2009504744 A5 JP2009504744 A5 JP 2009504744A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- solid dosage
- valsartan
- tablet
- mixing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000463 material Substances 0.000 claims description 38
- 239000007909 solid dosage form Substances 0.000 claims description 27
- 239000007888 film coating Substances 0.000 claims description 10
- 238000009501 film coating Methods 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 9
- 239000002356 single layer Substances 0.000 claims description 8
- 239000002552 dosage form Substances 0.000 claims description 7
- 229940043102 valsartan and amlodipine Drugs 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 4
- 239000003086 colorant Substances 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims description 2
- ZPBWCRDSRKPIDG-UHFFFAOYSA-N amlodipine benzenesulfonate Chemical compound OS(=O)(=O)C1=CC=CC=C1.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl ZPBWCRDSRKPIDG-UHFFFAOYSA-N 0.000 claims 18
- 239000004072 C09CA03 - Valsartan Substances 0.000 claims 14
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims 14
- 229960004699 valsartan Drugs 0.000 claims 14
- 229960004005 amlodipine besylate Drugs 0.000 claims 10
- 238000007873 sieving Methods 0.000 claims 9
- 239000000654 additive Substances 0.000 claims 7
- 230000000996 additive effect Effects 0.000 claims 6
- 238000000227 grinding Methods 0.000 claims 4
- 229960000528 amlodipine Drugs 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 2
- 230000003179 granulation Effects 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 206010002383 Angina Pectoris Diseases 0.000 claims 1
- 206010003210 Arteriosclerosis Diseases 0.000 claims 1
- 206010007558 Cardiac failure chronic Diseases 0.000 claims 1
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 1
- 208000007342 Diabetic Nephropathies Diseases 0.000 claims 1
- 208000032781 Diabetic cardiomyopathy Diseases 0.000 claims 1
- 206010019233 Headaches Diseases 0.000 claims 1
- 206010019280 Heart failures Diseases 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- 208000007177 Left Ventricular Hypertrophy Diseases 0.000 claims 1
- 208000018262 Peripheral vascular disease Diseases 0.000 claims 1
- 208000001647 Renal Insufficiency Diseases 0.000 claims 1
- 208000006011 Stroke Diseases 0.000 claims 1
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 1
- 208000010877 cognitive disease Diseases 0.000 claims 1
- 208000033679 diabetic kidney disease Diseases 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- -1 glidants Substances 0.000 claims 1
- 231100000869 headache Toxicity 0.000 claims 1
- 201000006370 kidney failure Diseases 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 208000010125 myocardial infarction Diseases 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US70908305P | 2005-08-17 | 2005-08-17 | |
| PCT/US2006/031699 WO2007022113A2 (en) | 2005-08-17 | 2006-08-15 | Solid dosage forms of valsartan and amlodipine and method of making the same |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013006668A Division JP2013091660A (ja) | 2005-08-17 | 2013-01-17 | バルサルタンとアムロジピンの固体投与形態およびその製造方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2009504744A JP2009504744A (ja) | 2009-02-05 |
| JP2009504744A5 true JP2009504744A5 (enExample) | 2012-08-16 |
Family
ID=37758280
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008527038A Pending JP2009504744A (ja) | 2005-08-17 | 2006-08-15 | バルサルタンとアムロジピンの固体投与形態およびその製造方法 |
| JP2013006668A Pending JP2013091660A (ja) | 2005-08-17 | 2013-01-17 | バルサルタンとアムロジピンの固体投与形態およびその製造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013006668A Pending JP2013091660A (ja) | 2005-08-17 | 2013-01-17 | バルサルタンとアムロジピンの固体投与形態およびその製造方法 |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US20080171086A1 (enExample) |
| EP (1) | EP1917002A2 (enExample) |
| JP (2) | JP2009504744A (enExample) |
| KR (3) | KR20120135356A (enExample) |
| CN (1) | CN101237859A (enExample) |
| AR (1) | AR055120A1 (enExample) |
| AU (2) | AU2006279670A1 (enExample) |
| BR (1) | BRPI0614790A2 (enExample) |
| CA (1) | CA2617367A1 (enExample) |
| EC (1) | ECSP088188A (enExample) |
| GT (1) | GT200600371A (enExample) |
| IL (1) | IL189021A0 (enExample) |
| MA (1) | MA29734B1 (enExample) |
| MX (1) | MX2008002267A (enExample) |
| NO (1) | NO20081310L (enExample) |
| NZ (1) | NZ565020A (enExample) |
| PE (1) | PE20070420A1 (enExample) |
| RU (2) | RU2008109913A (enExample) |
| TN (1) | TNSN08071A1 (enExample) |
| TW (1) | TW200740432A (enExample) |
| WO (1) | WO2007022113A2 (enExample) |
| ZA (1) | ZA200800397B (enExample) |
Families Citing this family (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EG24716A (en) | 2002-05-17 | 2010-06-07 | Novartis Ag | Combination of organic compounds |
| US8951562B2 (en) * | 2006-11-10 | 2015-02-10 | Atacama Labs Oy | Method and apparatus or dry granulation |
| FI20070521A7 (fi) | 2006-11-10 | 2008-05-11 | Atacama Labs Oy | Rakeita, tabletteja ja rakeistusmenetelmä |
| TR200703568A1 (tr) * | 2007-05-24 | 2008-07-21 | Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� | Valsartan formülasyonları |
| WO2009061713A1 (en) | 2007-11-06 | 2009-05-14 | Novartis Ag | Dual-acting pharmaceutical compositions based on superstructures of angiotensin receptor antagonist/blocker (arb) and neutral endopeptidase (nep) inhibitor |
| MX2010007281A (es) * | 2007-12-31 | 2010-10-05 | Lupin Ltd | Composiciones farmaceuticas de amlodipina y valsartan. |
| EP2291233B1 (en) | 2008-05-09 | 2019-09-04 | Atacama Labs Oy | Method for dry granulation |
| JO3239B1 (ar) | 2008-09-22 | 2018-03-08 | Novartis Ag | تركيبات جالينية من مركبات عضوية |
| DE102008051783A1 (de) * | 2008-10-17 | 2010-04-22 | Tiefenbacher Pharmachemikalien Alfred E. Tiefenbacher Gmbh & Co. Kg | Valsartan enthaltende Tablette |
| WO2010104485A2 (en) * | 2009-03-11 | 2010-09-16 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Valsartan formulations |
| CN101926798B (zh) * | 2009-06-26 | 2013-09-18 | 北京德众万全药物技术开发有限公司 | 一种含有氨氯地平和缬沙坦的分散片 |
| US20120107397A1 (en) * | 2009-07-03 | 2012-05-03 | Hetero Research Foundation | Pharmaceutical compositions of valsartan |
| CN101647797B (zh) * | 2009-09-18 | 2011-06-08 | 海南锦瑞制药股份有限公司 | 一种含有苯磺酸氨氯地平和缬沙坦的药物组合物及其制备方法 |
| CN102091069A (zh) * | 2009-12-11 | 2011-06-15 | 浙江华海药业股份有限公司 | 缬沙坦和氨氯地平的复方制剂及其制备方法 |
| CN101897675B (zh) * | 2010-02-10 | 2012-11-21 | 温士顿医药股份有限公司 | 含有凡尔沙坦或其药学上可接受的盐的固体剂型口服医药组成物 |
| CN101843615A (zh) * | 2010-06-25 | 2010-09-29 | 包丽昕 | 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法 |
| TR201102067A1 (tr) | 2011-03-03 | 2012-09-21 | Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ | Valsartan ve amlodipin kombinasyonları. |
| CN102283837A (zh) * | 2011-07-29 | 2011-12-21 | 江苏省药物研究所有限公司 | 缬沙坦和氨氯地平复方的固体制剂的制备方法 |
| CN102697778B (zh) * | 2012-06-21 | 2014-04-30 | 上海医药集团股份有限公司 | 缬沙坦氨氯地平复方固体制剂及其制备方法 |
| WO2013191668A1 (en) | 2012-06-22 | 2013-12-27 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Compositions preventing hypertension comprising soluplus |
| WO2014058047A1 (ja) * | 2012-10-12 | 2014-04-17 | 味の素株式会社 | カルシウム拮抗薬／アンジオテンシンｉｉ受容体拮抗薬含有医薬製剤の製造方法 |
| CN103006649B (zh) * | 2012-12-27 | 2014-06-25 | 石家庄市华新药业有限责任公司 | 一种复方制剂缬沙坦氨氯地平片（ⅰ）及其制备方法 |
| CZ2013783A3 (cs) | 2013-10-08 | 2015-04-15 | Zentiva, K. S | Stabilní farmaceutická kompozice obsahující amlodipin a valsartan |
| MX380070B (es) * | 2015-07-08 | 2025-03-11 | Cj Healthcare Corp | Una composición farmacéutica que comprende amlodipino, valsartán y rosuvastatina. |
| CN105232551A (zh) * | 2015-11-19 | 2016-01-13 | 哈尔滨圣吉药业股份有限公司 | 一种缬沙坦/苯磺酸氨氯地平复方制剂及其制备方法 |
| CN106176744A (zh) * | 2016-07-13 | 2016-12-07 | 精华制药集团股份有限公司 | 缬沙坦氨氯地平胶囊在制备治疗脑中风的药物中的应用 |
| ES3035030T3 (en) | 2016-10-07 | 2025-08-28 | Silvergate Pharmaceuticals Inc | Amlodipine formulations |
| EP3522888A4 (en) * | 2016-10-10 | 2020-06-10 | Alembic Pharmaceuticals Limited | STABLE PHARMACEUTICAL COMPOSITION WITH TELMISARTAN AND AMLODIPINE BESYLATE |
| CN109498626A (zh) * | 2017-09-14 | 2019-03-22 | 北京万全德众医药生物技术有限公司 | 一种稳定的复方制剂缬沙坦氨氯地平处方及其制备方法 |
| US10799453B2 (en) | 2018-04-11 | 2020-10-13 | Silvergate Pharmaceuticals, Inc. | Amlodipine formulations |
| CN109260160A (zh) * | 2018-08-30 | 2019-01-25 | 天津仁生医药科技有限公司 | 一种缬沙坦氨氯地平片剂及其制备方法 |
| CN109010338B (zh) * | 2018-09-13 | 2021-09-21 | 合肥合源药业有限公司 | 一种缬沙坦氨氯地平片的制备方法及缬沙坦氨氯地平片 |
| CN109157526A (zh) * | 2018-09-13 | 2019-01-08 | 合肥合源药业有限公司 | 一种缬沙坦氨氯地平复方制剂及其制备工艺 |
| CN109394712B (zh) * | 2018-11-23 | 2019-11-12 | 海南妙音春制药有限公司 | 一种缬沙坦氨氯地平复方片剂及其制备方法 |
| WO2025162195A1 (zh) * | 2024-01-30 | 2025-08-07 | 上海汇伦医药股份有限公司 | 包衣复方片剂 |
| CN120392682A (zh) * | 2024-01-30 | 2025-08-01 | 上海汇伦医药股份有限公司 | 速释组合物 |
| CN119925284B (zh) * | 2025-04-09 | 2025-07-11 | 杭州沐源生物医药科技有限公司 | 一种含有厄贝沙坦和氨氯地平的药物组合物及制备方法 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3152978B2 (ja) * | 1991-12-17 | 2001-04-03 | 塩野義製薬株式会社 | 二層錠およびその製造方法 |
| DE19539361A1 (de) * | 1995-10-23 | 1997-04-24 | Basf Ag | Verfahren zur Herstellung von mehrschichtigen, festen Arzneiformen zur oralen oder rektalen Verabreichung |
| DK1096932T3 (da) | 1998-07-10 | 2007-10-15 | Novartis Pharma Ag | Antihypertensiv kombination af valsartan og calciumkanalblokker |
| US6204281B1 (en) * | 1998-07-10 | 2001-03-20 | Novartis Ag | Method of treatment and pharmaceutical composition |
| DK1588706T3 (da) | 1998-12-23 | 2012-01-16 | Novartis Ag | Valsartantablet |
| JP3796562B2 (ja) * | 1999-05-26 | 2006-07-12 | ライオン株式会社 | 多層錠、多層錠の製造方法及び多層錠の剥離抑制方法 |
| US6395728B2 (en) * | 1999-07-08 | 2002-05-28 | Novartis Ag | Method of treatment and pharmaceutical composition |
| AU2002226365A1 (en) * | 2000-12-01 | 2002-06-11 | Novartis Ag | Combinations of an angiotensin receptor antagonist and an anti-hypertensive drug or a statin, for the treatment of sexual dysfunction |
| AR037565A1 (es) * | 2001-11-21 | 2004-11-17 | Synthon Bv | Formas de sales de amlodipina y procedimientos para prepararlas. |
| ES2445041T3 (es) * | 2002-01-16 | 2014-02-27 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Método para la preparación de telmisartán amorfo |
| EG24716A (en) * | 2002-05-17 | 2010-06-07 | Novartis Ag | Combination of organic compounds |
| WO2005070463A2 (en) * | 2004-01-12 | 2005-08-04 | Sepracor, Inc. | Compositions comprising (s)-amlodipine malate and an angiotensin receptor blocker and methods of their use |
| EP1559419A1 (en) * | 2004-01-23 | 2005-08-03 | Fournier Laboratories Ireland Limited | Pharmaceutical formulations comprising metformin and a fibrate, and processes for their obtention |
| AU2006206738A1 (en) * | 2005-01-19 | 2006-07-27 | Merck Sharp & Dohme Corp. | Mitotic kinesin inhibitors |
| WO2007001067A2 (en) * | 2005-06-27 | 2007-01-04 | Daiichi Sankyo Company, Limited | Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker |
-
2006
- 2006-08-11 GT GT200600371A patent/GT200600371A/es unknown
- 2006-08-15 WO PCT/US2006/031699 patent/WO2007022113A2/en not_active Ceased
- 2006-08-15 AU AU2006279670A patent/AU2006279670A1/en not_active Abandoned
- 2006-08-15 MX MX2008002267A patent/MX2008002267A/es unknown
- 2006-08-15 JP JP2008527038A patent/JP2009504744A/ja active Pending
- 2006-08-15 BR BRPI0614790-9A patent/BRPI0614790A2/pt not_active IP Right Cessation
- 2006-08-15 PE PE2006000992A patent/PE20070420A1/es not_active Application Discontinuation
- 2006-08-15 KR KR1020127030872A patent/KR20120135356A/ko not_active Abandoned
- 2006-08-15 EP EP06813435A patent/EP1917002A2/en not_active Withdrawn
- 2006-08-15 CN CNA2006800289354A patent/CN101237859A/zh active Pending
- 2006-08-15 NZ NZ565020A patent/NZ565020A/en not_active IP Right Cessation
- 2006-08-15 KR KR1020127014789A patent/KR20120078751A/ko not_active Ceased
- 2006-08-15 CA CA002617367A patent/CA2617367A1/en not_active Abandoned
- 2006-08-15 US US11/914,159 patent/US20080171086A1/en not_active Abandoned
- 2006-08-15 AR ARP060103556A patent/AR055120A1/es not_active Application Discontinuation
- 2006-08-15 RU RU2008109913/15A patent/RU2008109913A/ru unknown
- 2006-08-15 KR KR1020087003704A patent/KR20080034159A/ko not_active Withdrawn
- 2006-08-16 TW TW095130129A patent/TW200740432A/zh unknown
-
2008
- 2008-01-14 ZA ZA200800397A patent/ZA200800397B/xx unknown
- 2008-01-24 IL IL189021A patent/IL189021A0/en unknown
- 2008-02-08 MA MA30630A patent/MA29734B1/fr unknown
- 2008-02-15 EC EC2008008188A patent/ECSP088188A/es unknown
- 2008-02-15 TN TNP2008000071A patent/TNSN08071A1/en unknown
- 2008-03-12 NO NO20081310A patent/NO20081310L/no not_active Application Discontinuation
-
2010
- 2010-08-09 US US12/852,542 patent/US20100303906A1/en not_active Abandoned
- 2010-10-08 AU AU2010227062A patent/AU2010227062A1/en not_active Abandoned
-
2012
- 2012-02-23 US US13/403,638 patent/US20120177733A1/en not_active Abandoned
- 2012-07-24 RU RU2012131668/15A patent/RU2012131668A/ru not_active Application Discontinuation
-
2013
- 2013-01-17 JP JP2013006668A patent/JP2013091660A/ja active Pending
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