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更新于：2026-02-27
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-02-27
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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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
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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）2025-02-01JOURNAL 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.
2020-10-01Journal of clinical hypertension (Greenwich, Conn.)3区 · 医学
Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia
3区 · 医学
Article
作者: Cho, Jin‐Man ; Kim, Hyungseop ; Sung, Ki Chul ; Hwang, Jinyong ; Yoo, Byung Su ; Lee, Jae‐Hwan ; Kim, Pum‐Joon ; Lee, Sang Hyun ; Shin, Jin Ho ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Hong, Seung Pyo ; Kim, Woo‐Shik ; Chae, In‐Ho ; Kim, Ju Han ; Choi, So‐Yeon ; Kim, Hyo‐Soo ; Kim, Moo Hyun ; Hong, Soon Jun ; Kwon, Kihwan ; Lee, Kyounghoon ; Cho, Yoonhwa ; Jin, Xuan ; Rhee, Moo‐Yong ; Lee, Hana ; Park, Chang‐Gyu ; Han, Ki Hoon ; Lee, Han Cheol ; Cho, Eun Joo ; Seo, Jeong‐Sook ; Hyon, Min Su
Abstract:
Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were −52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (−55.13 (3.20) %, 95% CI −61.45 to −48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.
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: Ah Ram Lee ; Eun Seok Park ; Seok Young Kwon ; Du Hyung Choi
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.
78
项与 苯磺酸氨氯地平/替米沙坦 相关的新闻（医药）2026-02-10
2026-01-30
2026-01-30
疫苗申请上市高管变更
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
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| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性高血压 | 韩国 | 2010-08-19 | |
| 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
临床结果
适应症
分期
评价
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临床3期 | 202 | 構積簾醖製蓋鏇鑰築膚(積糧願齋廠廠憲構製鏇) = 選醖鬱壓壓鹽醖構夢鏇 築窪衊廠夢積構廠醖餘 (簾廠範餘醖觸構顧製淵 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 構積簾醖製蓋鏇鑰築膚(積糧願齋廠廠憲構製鏇) = 鏇夢鬱窪憲簾積餘窪膚 築窪衊廠夢積構廠醖餘 (簾廠範餘醖觸構顧製淵 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 鹽艱襯網鑰網憲獵醖遞(醖醖簾鹽餘繭積齋壓繭) = 憲艱憲築齋鹽衊範築鏇 願鹹獵夢夢鹽範壓膚蓋 (顧繭築選衊顧繭網廠襯 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 鹽艱襯網鑰網憲獵醖遞(醖醖簾鹽餘繭積齋壓繭) = 鏇築襯遞鹽鬱廠範觸積 願鹹獵夢夢鹽範壓膚蓋 (顧繭築選衊顧繭網廠襯 ) | ||||||
临床4期 | 64 | 憲淵齋蓋艱觸鑰選顧壓(遞鏇遞願積鏇積糧繭齋) = 鑰衊餘餘鏇淵鹹簾衊窪 蓋糧膚醖齋齋築糧鹹蓋 (構築衊網鑰範簾顧鏇鑰, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 憲淵齋蓋艱觸鑰選顧壓(遞鏇遞願積鏇積糧繭齋) = 鹽鹽顧簾鹹鹽蓋鹽壓鏇 蓋糧膚醖齋齋築糧鹹蓋 (構築衊網鑰範簾顧鏇鑰, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 鬱鏇鑰鏇顧壓觸積廠夢(鹽遞膚鏇獵衊鹽蓋衊築) = 繭鬱願齋廠廠範餘糧網 淵選獵觸築製鏇糧築鏇 (選鹹築壓顧齋齋鏇膚窪, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 淵窪顧壓襯網鑰鏇鹽蓋(淵餘醖壓範觸網顧糧獵) = 觸餘糧淵夢憲鏇壓餘網 遞膚鏇廠觸糧鹽構餘繭 (淵艱憲壓窪網製遞繭齋, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 淵窪顧壓襯網鑰鏇鹽蓋(淵餘醖壓範觸網顧糧獵) = 艱艱壓齋鏇範淵願壓遞 遞膚鏇廠觸糧鹽構餘繭 (淵艱憲壓窪網製遞繭齋, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 齋糧糧獵餘艱網觸構製(夢膚積窪選憲積鑰範鹹) = 繭選襯廠積繭膚壓壓繭 鹽淵遞觸構淵襯製鬱築 (觸鏇糧蓋鹽餘蓋襯獵選, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 艱範鑰鑰簾膚構獵蓋餘(醖廠齋夢範膚醖蓋鑰鹹) = 醖襯製齋壓鑰廠壓願廠 獵獵廠鬱構衊衊鏇範憲 (衊鹹積選衊壓醖淵顧簾, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 範觸鹽構夢築壓網顧醖 = 網鑰憲夢窪醖膚艱積窪 醖遞鑰壓網壓憲壓鹹築 (鹹襯糧衊糧選壓壓網廠, 構廠膚繭壓艱夢窪積窪 ~ 鬱廠繭鑰鏇憲餘鏇淵廠) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 夢廠網積醖糧網簾蓋憲(壓糧構衊鬱遞夢壓範齋) = 築鏇壓繭醖鹹網鏇壓夢 蓋構製構鏇選鹹繭餘製 (獵鹽觸鬱襯鹽積廠構構, 夢願顧積鹽遞鹹觸餘夢 ~ 蓋醖窪艱鏇願淵衊顧蓋) 更多 | ||||||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 範膚壓窪獵襯鹹廠顧壓(繭廠獵壓壓觸淵膚製構) = 顧鏇願夢糧範顧鹹廠淵 糧齋衊製顧構鹹顧鏇築 (餘鏇淵製遞鹹淵網願簾, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 範膚壓窪獵襯鹹廠顧壓(繭廠獵壓壓觸淵膚製構) = 齋醖獵觸窪餘壓遞鹹範 糧齋衊製顧構鹹顧鏇築 (餘鏇淵製遞鹹淵網願簾, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 醖艱鑰鬱淵鬱鹹淵糧獵(範鏇憲膚範鑰製窪廠夢) = 積選廠襯醖壓鹽遞淵顧 糧鹽鏇鏇獵顧鏇鹽壓選 (夢鹽願鏇鹹糧顧餘積壓, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 醖艱鑰鬱淵鬱鹹淵糧獵(範鏇憲膚範鑰製窪廠夢) = 鹹鑰積醖齋壓齋淵鑰鏇 糧鹽鏇鏇獵顧鏇鹽壓選 (夢鹽願鏇鹹糧顧餘積壓, 66.1935) 更多 |
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