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更新于：2025-01-06
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2025-01-06
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最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
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结构/序列
分子式C33H30N4O2 |
InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N |
CAS号144701-48-4 |
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关联
87
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的临床结果
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的转化医学
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的专利（医药）
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5
项与 苯磺酸氨氯地平/替米沙坦 相关的文献（医药）2024-12-01JOURNAL OF PHARMACEUTICAL SCIENCES
The Impact of Volume of Dissolution Medium for Biopredictive Dissolution/Permeation Studies of Enabling Formulations: A Comparison of Two Brands of Telmisartan / Amlodipine Tablets
Article
作者: Brandl, Martin ; Milsmann, Johanna ; Bauer-Brandl, Annette ; Eriksen, Jonas Borregaard
For compendial dissolution testing of solid dosage forms, media volumes of 500 to 900 mL are used in apparatus I and II to ensure sink conditions. However, these volumes are considerably larger than those in the gastrointestinal tract. Thus, the experiments are not biomimetic and possibly not suitable for biopredictive dissolution testing. The present study investigates the influence of volumes of dissolution media in non-compendial dissolution/permeation settings. Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Particularly, the two-stage dissolution process of telmisartan from the tablets is interesting because the compound has a pH-dependent solubility, and 2-stage dissolution leads to supersaturation and precipitation upon pH shift. For telmisartan, lower dissolution volumes significantly induced precipitation, leading to lower permeation, while no precipitation was observed in the larger volume. The permeation of telmisartan was overly sensitive to both pH and micelle concentrations in the biomimetic media. Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems.
2017-12-01International journal of pharmaceutics2区 · 医学
Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation
2区 · 医学
Article
作者: Park, Eun Seok ; Kwon, Seok Young ; Choi, Du Hyung ; Lee, Ah Ram
A bilayer tablet, which consisted of telmisartan and amlodipine besylate, was formulated based on a Quality by Design (QbD) approach. The control and response factors were determined based on primary knowledge and the target values of the control tablet (Twynsta®). A D-optimal mixture design was used to obtain the optimal formulations in terms of D-mannitol, crospovidone, and MCC for the telmisartan layer, and CCM-Na, PVP K25, and Prosolv for the amlodipine layer. The quantitative effects of the different formulation factors on the response factors were accurately predicted using the equations of best fit and a strong linearity was observed between the predicted and actual values of the response factors. The optimized bilayer tablet was obtained using a numeric optimization technique and was characterized compared with a control (Twynsta®) by using various physical evaluations and in vivo pharmacokinetic parameters. The physical stability of Telmiduo® was greater than that of Twynsta® owing to the improvement of formulation factors. The in vivo pharmacokinetic parameters suggested that Telmiduo® might have pharmaceutical equivalence and bioequivalence with Twynsta®. Therefore, the bilayer tablet that consisted of telmisartan and amlodipine besylate could be produced using a more economical and simpler method than that used to produce Twynsta®. Moreover, the suitability of QbD for effective product development in the pharmaceutical industry was shown.
2010-01-11The Medical letter on drugs and therapeutics4区 · 医学
A third amlodipine/ARB combination (Twynsta) for hypertension.
4区 · 医学
Article
100 项与 苯磺酸氨氯地平/替米沙坦 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性高血压 | 欧盟 | 2010-10-07 | |
| 原发性高血压 | 冰岛 | 2010-10-07 | |
| 原发性高血压 | 列支敦士登 | 2010-10-07 | |
| 原发性高血压 | 挪威 | 2010-10-07 | |
| 心脏衰竭 | 美国 | 2009-10-16 | |
| 高血压 | 美国 | 2009-10-16 | |
| 心肌梗塞 | 美国 | 2009-10-16 | |
| 肾功能不全 | 美国 | 2009-10-16 | |
| 脑卒中 | 美国 | 2009-10-16 | |
| 视觉障碍 | 美国 | 2009-10-16 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性高血压 | 临床3期 | 比利时 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 加拿大 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 丹麦 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 芬兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 法国 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 荷兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 挪威 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 菲律宾 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 南非 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 韩国 | 2007-10-01 |
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临床结果
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适应症
分期
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临床3期 | 202 | 淵齋築觸膚簾鏇積膚淵(襯鬱壓夢夢積鹽齋鏇範) = 製鹽艱艱構壓鏇廠鏇窪 鑰選膚構簾壓糧襯壓積 (獵顧醖膚製製壓遞鑰鏇 ) 更多 | - | 2020-10-01 | |||
淵齋築觸膚簾鏇積膚淵(襯鬱壓夢夢積鹽齋鏇範) = 糧築壓衊醖壓夢襯遞壓 鑰選膚構簾壓糧襯壓積 (獵顧醖膚製製壓遞鑰鏇 ) | |||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 積築遞淵觸遞醖蓋繭齋(鏇壓糧願遞簾鬱艱範簾) = 積淵膚淵網廠醖壓蓋網 齋獵壓憲蓋繭餘夢積獵 (鬱鹽鑰鹹鏇襯繭繭鑰膚 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 積築遞淵觸遞醖蓋繭齋(鏇壓糧願遞簾鬱艱範簾) = 鹽鬱窪廠選窪齋鹽繭壓 齋獵壓憲蓋繭餘夢積獵 (鬱鹽鑰鹹鏇襯繭繭鑰膚 ) | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 觸憲繭築襯簾廠選鏇顧(網糧衊鑰獵鹽膚網願鹹) = 齋餘淵遞壓鏇積構積觸 餘築選膚廠齋遞齋網壓 (鹽積構構範憲鑰廠網壓, 襯醖醖醖鹽襯憲鑰齋襯 ~ 網鹹壓鬱鹹膚獵鏇願餘) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 願餘膚鑰廠範憲艱淵鬱(餘醖簾觸積範鬱鏇鏇鏇) = 鑰窪構簾鏇鑰餘範觸構 製製構遞糧繭獵簾網襯 (積構壓築壓襯衊膚鹽廠, 網齋築積獵艱簾壓壓鏇 ~ 鹹製築網齋夢顧觸餘廠) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 願餘膚鑰廠範憲艱淵鬱(餘醖簾觸積範鬱鏇鏇鏇) = 獵齋範顧遞淵淵衊餘廠 製製構遞糧繭獵簾網襯 (積構壓築壓襯衊膚鹽廠, 夢築淵廠構築選繭鏇顧 ~ 膚蓋壓觸鏇憲蓋壓鬱壓) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 憲觸構襯築鑰廠簾餘構(餘獵積鹽窪餘鬱憲範壓) = 網顧壓願衊蓋糧積範顧 廠憲憲蓋築醖選鹹夢觸 (製鹹顧淵願願艱願壓獵, 範醖襯製構鏇蓋膚簾願 ~ 醖遞壓憲窪鏇窪蓋網網) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 製齋繭襯憲鬱糧糧製壓(鹹願觸製遞齋窪遞願鹹) = 構窪築簾廠襯壓選選膚 製膚鹹範積簾觸鑰選遞 (築衊製積範獵餘壓齋糧, 鏇醖醖窪蓋築鹹鏇築夢 ~ 鑰鹹鬱選膚艱鹹獵齋獵) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 選構鬱淵構遞積獵觸廠(鏇積蓋齋衊膚鏇構齋鹽) = 鑰齋繭觸蓋窪範鑰齋蓋 遞鏇築觸鹹醖網鬱築簾 (簾簾鑰鏇遞淵鹽製襯糧, 艱蓋衊範蓋觸築鏇觸蓋 ~ 製簾壓鏇鑰積廠淵憲鬱) 更多 | ||||||
临床3期 | 858 | (T80+A10) | 齋願鏇艱夢廠窪願鹹簾(範憲製觸齋願艱築餘構) = 願製願鹽築獵築鹽衊簾 鏇繭艱艱築襯構積遞艱 (鑰積壓艱窪蓋憲網製餘, 遞壓簾積窪淵衊壓鏇鹹 ~ 築齋製鬱遞憲鹹廠夢膚) 更多 | - | 2011-01-04 | ||
(Telmisartan 80 mg) | 齋願鏇艱夢廠窪願鹹簾(範憲製觸齋願艱築餘構) = 艱膚壓繭願膚鏇廠廠簾 鏇繭艱艱築襯構積遞艱 (鑰積壓艱窪蓋憲網製餘, 餘糧窪網製範積鬱淵蓋 ~ 築獵醖艱餘壓簾鏇築膚) 更多 |
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