KR20050053690A - 텔미사탄을 포함하는 고형 약제학적 제형 - Google Patents
텔미사탄을 포함하는 고형 약제학적 제형 Download PDFInfo
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- KR20050053690A KR20050053690A KR1020057005123A KR20057005123A KR20050053690A KR 20050053690 A KR20050053690 A KR 20050053690A KR 1020057005123 A KR1020057005123 A KR 1020057005123A KR 20057005123 A KR20057005123 A KR 20057005123A KR 20050053690 A KR20050053690 A KR 20050053690A
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
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- 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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Abstract
Description
제형 | C | D | E | F | G |
텔미사탄 | 40.0㎖ | 40.0㎖ | 40.0㎖ | 40.0㎖ | 40.0㎖ |
메글루민 | 40.0㎖ | 40.0㎖ | 40.0㎖ | 40.0㎖ | 40.0㎖ |
폴록사머188 | 8.0㎖ | 8.0㎖ | 8.0㎖ | 8.0㎖ | 8.0㎖ |
D-만니톨 | 81.5㎖ | 8060㎖ | - | 70.6㎖ | - |
에리트리톨 | - | - | 80.5㎖ | - | - |
소르비톨 | - | - | - | 10.0㎖ | - |
수크로오스 | - | - | - | - | 80.6㎖ |
결정성 셀룰로오스 | 30.0㎖ | - | - | - | - |
약한 무수 규산 | - | - | 0.1㎖ | - | - |
스테아르산마그네슘 | 0.5㎖ | 1.4㎖ | 1.4㎖ | 1.4㎖ | 1.4㎖ |
총량 | 200.0㎖ | 40.0㎖ | 170.0㎖ | 170.0㎖ | 170.0㎖ |
타정기 | Fette 3090 |
타정 속도 | 100,000(80,000 내지 120,000)정제수/시간 |
회전날 속도 | 약 30rpm |
압축력 | 7(5 내지 10)KN |
제형 | A | B |
텔미사탄메글루민폴록사머188D-만니톨결정성 셀룰로오스(Avicel PH101)스테아르산마그네슘 | 40㎎40㎎8㎎81㎎30㎎1㎎ | 40㎎40㎎0㎎89㎎30㎎1㎎ |
총량 | 200㎎/cap | 200㎎/cap |
Claims (14)
- 기제와 텔미사탄의 몰 비 1:1 내지 10:1에 해당하는 기제(a),최종 조성물의 약 1 내지 20중량%에 해당하는 계면활성제 또는 유화제(b),수용성 희석제(c) 25 내지 70중량% 및임의로, 추가의 부형제 및/또는 보조제(d) 0 내지 20중량%를 포함하는, 용해 매트릭스에 분산된 텔미사탄 3 내지 50중량%(여기서, 모든 구성 성분의 총량은 100중량%이다)를 포함하는 약제학적 조성물.
- 제1항에 있어서, 기제가 NaOH 및 KOH 같은 금속 수산화물이거나; NaHCO3, KHCO3, Na2CO3, K2CO3, Na2HPO4, K2HPO4, 아르기닌 같은 기초 아미노산 및 메글루민(N-메틸-D-글루카민)으로부터 선택되는 약제학적 조성물.
- 제1항에 있어서, 계면활성제 및 유화제가, 폴록사머 또는 플루오닉, 폴리에틸렌 글리콜, 폴리에틸렌 글리콜 모노스테아레이트, 폴리소르베이트, 나트륨 라우릴 설페이트, 폴리에톡시화 피마자유 및 수소화 피마자유로부터 선택되는 약제학적 조성물.
- 제1항에 있어서, 계면활성제 및 유화제가 평균 몰 중량이 약 2,000 내지 12,000인 폴록사머로부터 선택되는 약제학적 조성물.
- 제4항에 있어서, 폴록사머가 폴록사머 182LF, 폴록사머 331 및 폴록사머 188로부터 선택되는 약제학적 조성물.
- 제1항에 있어서, 수용성 희석제가 글루코오스 같은 단당류; 수크로오스 같은 올리고당; 및 에리트리톨, 소르비톨, 만니톨, 둘시톨, 리비톨 및 자일리톨 같은 당 알코올과 같은 카보하이드레이트로부터 선택되는 약제학적 조성물.
- 제1항에 있어서, 기타 부형제 및/또는 보조제가 결합제, 담체, 윤활제, 유동 조절제, 결정화 억제제, 가용화제 및 착색제로부터 선택되는 약제학적 조성물.
- 제1항 내지 제7항 중의 어느 한 항의 약제학적 조성물로부터 제조한, 복용/섭취용의 고형 경구투여용 약제학적 제형.
- 제8항에 있어서, 캡슐 또는 정제 형태인 약제학적 제형.
- 제8항 또는 제9항에 있어서, 단위 용량에 텔미사탄 10 내지 160㎎을 포함하는 약제학적 제형.
- 제1항 내지 제7항 중의 어느 한 항의 약제학적 조성물로부터 제조한 제1 텔미사탄 함유 정제층과 붕해성 정제 매트릭스 내에 이뇨제를 함유하는 제2 정제층을 포함하는 이중층 약제학적 정제.
- 텔미사탄 3 내지 50중량%를, 기제와 텔미사탄의 몰 비 1:1 내지 10:1에 해당하는 기제(a) 및 비이온성 계면활성제 또는 유화제(b) 약 1 내지 20중량%와 함께 물 또는 에탄올과 물의 혼합액에 용해시킴으로써 과립액을 수용액으로서 제조하는 단계(ⅰ),수용성 희석제 25 내지 70중량%를, 임의로, 건식 결합제 10 내지 20중량%와 함께 유동층 과립화기에 주입하여 예비-혼합을 수행하는 단계(ⅱ),과립화기 내에 있는 성분들에 분무하기 위한 과립액을 사용하여 유동층 과립화를 수행하는 단계(ⅲ),과립화 종료 후, 수득한 과립을 건조시키고, 임의로, 스크리닝(screening)하는 단계(ⅳ) 및임의로, 이렇게 수득한 과립을 분쇄시켜 소정의 입자 크기 분포를 갖는 분말 조성물을 생성시키는 단계(v)(여기서, 주어진 모든 백분율은 제조되는 최종 조성물을 기준으로 한다)를 포함함을 특징으로 하는 유동층 과립화 공정(A)을 이용하여 제1항의 약제학적 조성물을 제조하는 방법.
- 텔미사탄 3 내지 50중량%를, 기제와 텔미사탄의 몰 비 1:1 내지 10:1에 해당하는 기제(a) 및 비이온성 계면활성제 또는 유화제(b) 약 1 내지 20중량%와 함께 물 또는 에탄올과 물의 혼합액에 용해시킴으로써 수성 분무액을 제조하는 단계(ⅰ),수성 분무액을 분무-건조시켜 분무-건조된 입자를 수득하는 단계(ⅱ),분무-건조된 과립을 수용성 희석제 25 내지 70중량%와 혼합하여 예비 혼합물을 수득하는 단계(ⅲ),임의로, 예비 혼합물을 윤활제와 혼합하는 단계(ⅳ) 및임의로, 단계(ⅰ) 내지 단계(ⅳ) 중의 어느 한 단계에서 추가의 부형제 및/또는 보조제를 첨가하는 단계(ⅴ)(여기서, 주어진 모든 백분율은 제조되는 최종 조성물을 기준으로 한다)를 포함함을 특징으로 하는 분무-건조 공정(B)을 이용하여 제1항의 약제학적 조성물을 제조하는 방법.
- 제12항 또는 제13항의 방법을 사용하여 텔미사탄을 포함하는 제1 정제층 조성물을 제공하는 단계(ⅰ),이뇨제를 붕해성 정제 매트릭스 및, 임의로, 추가의 부형제 및/또는 보조제와 혼합하고/하거나 과립화하고(a), 윤활제를 혼합하여 제2 정제층용 최종 혼합물을 수득함(b)으로써, 제2 정제층 조성물을 제공하는 단계(ⅱ),제1 정제층 또는 제2 정제층 조성물을 타정기에 주입하는 단계(ⅲ),정제층 조성물을 압축시켜 정제층을 형성하는 단계(ⅳ),기타 정제층 조성물을 타정기에 주입하는 단계(ⅴ) 및양 정제층 조성물을 압축시켜 이중층 정제를 제조하는 단계(ⅵ)를 포함함을 특징으로 하는, 제11항의 이중층 약제학적 정제의 제조방법.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10244681.4 | 2002-09-24 | ||
DE10244681A DE10244681A1 (de) | 2002-09-24 | 2002-09-24 | Neue feste Telmisartan enthaltende pharmazeutische Formulierungen und deren Herstellung |
PCT/EP2003/010382 WO2004028505A1 (en) | 2002-09-24 | 2003-09-18 | Solid pharmaceutical formulations comprising telmisartan |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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KR1020117025399A Division KR101188650B1 (ko) | 2002-09-24 | 2003-09-18 | 텔미사탄을 함유하는 제1 정제층과 이뇨제를 함유하는 제2 붕해성 정제층을 포함하는 이중층 약제학적 정제 및 이의 제조방법 |
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KR20050053690A true KR20050053690A (ko) | 2005-06-08 |
KR101107508B1 KR101107508B1 (ko) | 2012-01-31 |
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KR1020117025399A KR101188650B1 (ko) | 2002-09-24 | 2003-09-18 | 텔미사탄을 함유하는 제1 정제층과 이뇨제를 함유하는 제2 붕해성 정제층을 포함하는 이중층 약제학적 정제 및 이의 제조방법 |
KR1020057005123A KR101107508B1 (ko) | 2002-09-24 | 2003-09-18 | 텔미사탄을 포함하는 고형 약제학적 제형 |
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KR1020117025399A KR101188650B1 (ko) | 2002-09-24 | 2003-09-18 | 텔미사탄을 함유하는 제1 정제층과 이뇨제를 함유하는 제2 붕해성 정제층을 포함하는 이중층 약제학적 정제 및 이의 제조방법 |
Country Status (32)
Country | Link |
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EP (1) | EP1545467B1 (ko) |
JP (1) | JP4606166B2 (ko) |
KR (2) | KR101188650B1 (ko) |
CN (2) | CN101785769A (ko) |
AR (2) | AR041370A1 (ko) |
AT (1) | ATE372765T1 (ko) |
AU (1) | AU2003270220B2 (ko) |
BR (1) | BR0314687A (ko) |
CA (1) | CA2499878C (ko) |
CY (1) | CY1107075T1 (ko) |
DE (2) | DE10244681A1 (ko) |
DK (1) | DK1545467T3 (ko) |
EA (1) | EA009237B1 (ko) |
EC (1) | ECSP055688A (ko) |
ES (1) | ES2294312T3 (ko) |
HR (1) | HRP20050280B1 (ko) |
IL (1) | IL167610A (ko) |
ME (1) | MEP46008A (ko) |
MX (1) | MXPA05003039A (ko) |
MY (1) | MY136524A (ko) |
NO (1) | NO334449B1 (ko) |
NZ (1) | NZ539522A (ko) |
PE (1) | PE20040418A1 (ko) |
PL (1) | PL206396B1 (ko) |
PT (1) | PT1545467E (ko) |
RS (1) | RS51756B (ko) |
SI (1) | SI1545467T1 (ko) |
TW (1) | TWI319319B (ko) |
UA (1) | UA81781C2 (ko) |
UY (1) | UY27995A1 (ko) |
WO (1) | WO2004028505A1 (ko) |
ZA (1) | ZA200501087B (ko) |
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ES2277199T3 (es) * | 2004-04-15 | 2007-07-01 | Helm Ag | Procedimiento para la preparacion de adsorbatos de valsartan pulverulentos de flujo libre. |
US20060078615A1 (en) * | 2004-10-12 | 2006-04-13 | Boehringer Ingelheim International Gmbh | Bilayer tablet of telmisartan and simvastatin |
WO2006044648A1 (en) | 2004-10-15 | 2006-04-27 | Teva Pharmaceutical Industries Ltd. | Process for preparing telmisartan |
KR20070072588A (ko) * | 2004-11-03 | 2007-07-04 | 테바 파마슈티컬 인더스트리즈 리미티드 | 텔미사르탄 나트륨의 비정질형 및 다형 |
CA2582049C (en) * | 2004-11-05 | 2010-08-24 | Boehringer Ingelheim International Gmbh | Bilayer tablet comprising telmisartan and amlodipine |
US9149433B2 (en) * | 2004-11-30 | 2015-10-06 | Basf Corporation | Method for formation of micro-prilled polymers |
CN100370984C (zh) * | 2005-03-11 | 2008-02-27 | 浙江泰利森药业有限公司 | 替米沙坦分散片及其制备方法 |
CN101312714A (zh) * | 2005-11-22 | 2008-11-26 | 特瓦制药工业有限公司 | 替米沙坦的药用组合物 |
US8637078B2 (en) * | 2005-11-24 | 2014-01-28 | Boehringer Ingelheim International Gmbh | Bilayer tablet comprising telmisartan and diuretic |
EP2029112B2 (en) | 2006-06-16 | 2014-02-19 | LEK Pharmaceuticals d.d. | Pharmaceutical composition comprising hydrochlorothiazide and telmisartan |
GB0613925D0 (en) | 2006-07-13 | 2006-08-23 | Unilever Plc | Improvements relating to nanodispersions |
EP1908469A1 (en) | 2006-10-06 | 2008-04-09 | Boehringer Ingelheim Vetmedica Gmbh | Angiotensin II receptor antagonist for the treatment of systemic diseases in cats |
EP1970053A1 (en) * | 2007-03-14 | 2008-09-17 | Boehringer Ingelheim Pharma GmbH & Co. KG | Pharmaceutical composition |
FR2918277B1 (fr) * | 2007-07-06 | 2012-10-05 | Coretecholding | Nouveau procede de production de formes pharmaceutiques seches hydrodispersibles et les compositions hydrodispersibles ainsi obtenues |
EP2291177A2 (en) | 2008-05-05 | 2011-03-09 | Farmaprojects, S.A. | Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale |
CZ2008469A3 (cs) * | 2008-07-31 | 2009-10-29 | Zentiva, A. S. | Telmisartan tablety |
NZ590948A (en) | 2008-07-31 | 2012-06-29 | Takeda Pharmaceutical | Solid pharmaceutical composition comprising a diuretic, ph control agent and an oxadiazole |
BRPI1013037A2 (pt) * | 2009-05-20 | 2019-09-24 | Boehringer Ingelheim Ipharmaceuticals Inc | "solução farmacêutica oral de telmisartan" |
EP2443094B1 (en) | 2009-06-19 | 2013-03-20 | Krka Tovarna Zdravil, D.D., Novo Mesto | Process for the preparation of telmisartan |
WO2011002423A2 (en) | 2009-07-02 | 2011-01-06 | Mahmut Bilgic | Solubility enhancing pharmaceutical composition |
EP2448575A2 (en) | 2009-07-02 | 2012-05-09 | Bilgic Mahmut | Pharmaceutical composition increasing solubility and stability |
JP2011136908A (ja) * | 2009-12-25 | 2011-07-14 | Kyowa Yakuhin Kogyo Kk | アンギオテンシンii受容体拮抗剤を含む固形製剤および固形製剤におけるアンギオテンシンii受容体拮抗剤の保存安定性向上方法 |
CA2706292A1 (en) * | 2010-05-28 | 2011-11-28 | Pharmascience Inc. | A stable pharmaceutical formulation comprising telmisartan and hydrochlorothiazide |
WO2011161123A2 (en) | 2010-06-21 | 2011-12-29 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Multilayer pharmaceutical tablet comprising telmisartan and a diuretic |
TWI564008B (zh) * | 2010-09-30 | 2017-01-01 | 鹽野義製藥股份有限公司 | 難溶性藥物之溶解性改善製劑 |
CN102133189B (zh) * | 2011-03-18 | 2012-06-27 | 海南美兰史克制药有限公司 | 替米沙坦脂质体固体制剂 |
JP6081376B2 (ja) * | 2011-12-28 | 2017-02-15 | ニプロ株式会社 | アンギオテンシンii拮抗作用を有する化合物を含有する固形医薬組成物 |
EP2612658A1 (en) | 2012-01-05 | 2013-07-10 | Laboratorios Lesvi, S.L. | Pharmaceutical compositions of 4'-[(1,4'dimethyl-2'-propyl[2,6'-bi-1h-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid and is 6-chloro-3,4-dihydro-2h-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide |
WO2014068507A1 (en) | 2012-11-02 | 2014-05-08 | Abbott Healthcare Pvt. Ltd. | Solid oral pharmaceutical compositions of telmisartan, essentially free of surfactants |
EP2952196A4 (en) | 2013-01-31 | 2016-08-03 | Sawai Seiyaku Kk | MULTILAYER TABLET CONTAINING TELMISARTAN AND HYDROCHLOROTHIAZIDE |
JP6218664B2 (ja) * | 2013-04-04 | 2017-10-25 | 沢井製薬株式会社 | テルミサルタン含有錠剤 |
JP6344678B2 (ja) * | 2013-09-27 | 2018-06-20 | キョーリンリメディオ株式会社 | テルミサルタン含有製剤及びその製造方法 |
CN104688696B (zh) * | 2013-12-04 | 2017-12-19 | 长春海悦药业股份有限公司 | 一种含有坎地沙坦酯的药物组合物 |
JP6428340B2 (ja) * | 2014-05-23 | 2018-11-28 | ニプロ株式会社 | テルミサルタンを含む医薬組成物の造粒方法 |
JP6440294B2 (ja) * | 2014-07-01 | 2018-12-19 | 大原薬品工業株式会社 | テルミサルタン含有フィルムコーティング錠剤 |
EP2979691A1 (en) * | 2014-07-30 | 2016-02-03 | Boehringer Ingelheim International GmbH | Oral disintegrating tablet |
WO2016080357A1 (ja) * | 2014-11-19 | 2016-05-26 | ニプロ株式会社 | 口腔内崩壊錠の製造方法 |
JP5827428B1 (ja) * | 2015-01-15 | 2015-12-02 | 日新製薬株式会社 | テルミサルタン含有錠剤 |
CN104739833A (zh) * | 2015-02-16 | 2015-07-01 | 江苏欧信医药化工有限公司 | 含替米沙坦和瑞舒伐他汀钙的复方双层片剂及其制备方法 |
JP5956034B1 (ja) * | 2015-07-27 | 2016-07-20 | エルメッド エーザイ株式会社 | テルミサルタン含有医薬組成物 |
CN107982232A (zh) * | 2018-01-29 | 2018-05-04 | 威特(湖南)药业有限公司 | 替米沙坦片及其制备方法 |
CN109350604B (zh) * | 2018-11-20 | 2020-04-21 | 广州迈达康医药科技有限公司 | 一种替米沙坦肠溶片及其制备方法 |
CN110934848B (zh) * | 2019-12-20 | 2022-02-15 | 江西杏林白马药业股份有限公司 | 一种替米沙坦胶囊及其制备方法 |
CN111265488B (zh) * | 2020-03-18 | 2021-11-12 | 重庆康刻尔制药股份有限公司 | 一种替米沙坦片及其制备方法 |
CN112870174A (zh) * | 2021-02-08 | 2021-06-01 | 天方药业有限公司 | 一种替米沙坦片剂的制备方法 |
CN115245497A (zh) * | 2021-04-26 | 2022-10-28 | 武汉伯睿科医药科技有限公司 | 替米沙坦胶囊及其制备工艺 |
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TW442301B (en) * | 1995-06-07 | 2001-06-23 | Sanofi Synthelabo | Pharmaceutical compositions containing irbesartan |
WO2000027396A1 (en) * | 1998-11-06 | 2000-05-18 | Glaxo Group Limited | Medicaments based on combinations of lacidipine and telmisartan or of physiological derivatives thereof |
WO2000027397A1 (en) * | 1998-11-06 | 2000-05-18 | Glaxo Group Limited | Antihypertensive medicaments containing lacidipine and telmisartan |
FR2787330A1 (fr) * | 1998-12-18 | 2000-06-23 | Sanofi Sa | Composition pharmaceutique contenant, en association, un antagoniste des recepteurs at1 de l'angiotensine ii et un immunosuppresseur pour la prevention ou le traitement des complications vasculaires du rejet de greffe |
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JP2001139461A (ja) * | 1999-11-10 | 2001-05-22 | Ohta Pharmaceut Co Ltd | 速崩壊性錠剤 |
JP2001278812A (ja) * | 2000-03-27 | 2001-10-10 | Kyoto Pharmaceutical Industries Ltd | 錠剤用崩壊剤及びこれを用いた錠剤 |
CZ303145B6 (cs) * | 2002-01-16 | 2012-05-02 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Zpusob výroby dvojvrstevné farmaceutické tablety obsahující telmisartan a hydrochlorthiazid |
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