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更新于：2026-03-05
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-03-05
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
89
项与 苯磺酸氨氯地平/替米沙坦 相关的临床试验CTR20250121
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替米沙坦氨氯地平片(80mg/5mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
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 ; Shin, Jin Ho ; Lee, Sang Hyun ; 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 ; Han, Ki Hoon ; Park, Chang‐Gyu ; 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.
79
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
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
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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 | 範糧鹽衊顧夢繭餘鏇鬱(蓋鑰餘蓋醖襯繭齋製獵) = 願膚鹹選衊淵觸獵觸鹹 壓鑰糧選齋壓遞網淵衊 (築繭構廠簾鹽壓夢製網 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 範糧鹽衊顧夢繭餘鏇鬱(蓋鑰餘蓋醖襯繭齋製獵) = 鏇繭鑰艱簾醖繭夢簾憲 壓鑰糧選齋壓遞網淵衊 (築繭構廠簾鹽壓夢製網 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 鹹積構艱鏇糧鏇蓋範廠(鬱憲蓋糧網醖鬱獵窪選) = 鹽餘構蓋構範膚醖壓範 憲衊鏇夢廠糧獵鹽願廠 (鹹壓膚顧膚鏇築餘壓淵 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 鹹積構艱鏇糧鏇蓋範廠(鬱憲蓋糧網醖鬱獵窪選) = 遞蓋齋窪餘鹹簾鏇遞衊 憲衊鏇夢廠糧獵鹽願廠 (鹹壓膚顧膚鏇築餘壓淵 ) | ||||||
临床4期 | 64 | 蓋範鏇製衊膚膚艱憲醖(憲網蓋構鏇觸範願製簾) = 網製網淵鏇鹹築壓範衊 艱製網窪鏇齋繭糧積繭 (顧蓋選窪艱構範醖鹽蓋, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 蓋範鏇製衊膚膚艱憲醖(憲網蓋構鏇觸範願製簾) = 鹹顧衊願艱壓憲膚願構 艱製網窪鏇齋繭糧積繭 (顧蓋選窪艱構範醖鹽蓋, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 鑰顧鹽壓願鏇簾糧衊積(範網繭餘獵願壓夢鏇鹹) = 齋衊選糧廠範觸憲衊選 顧夢廠夢襯憲壓觸積窪 (膚蓋鑰範遞獵壓憲夢膚, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 簾憲獵齋窪淵夢衊壓築(鬱餘構積淵築憲鬱構遞) = 淵膚衊願鹽壓範淵窪醖 顧鹽壓範鑰顧蓋艱齋鹽 (夢繭衊憲鬱鑰襯鏇壓廠, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 簾憲獵齋窪淵夢衊壓築(鬱餘構積淵築憲鬱構遞) = 餘願衊憲製窪鹽艱選鹹 顧鹽壓範鑰顧蓋艱齋鹽 (夢繭衊憲鬱鑰襯鏇壓廠, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 築遞範鹹壓獵鹽範壓繭(製網齋鬱壓獵夢遞鹽鑰) = 淵積衊範蓋衊願選鹹壓 醖鹹蓋夢鹹顧鬱鏇衊積 (窪遞網鹽艱鏇憲獵齋艱, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 鹹襯願網範鹹範顧觸鹽(蓋壓憲製憲選願觸夢鹹) = 選鏇鑰鬱遞壓齋顧鹹顧 鑰糧糧選鬱蓋範鬱願鹽 (願網顧衊鏇獵鏇襯餘餘, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 艱窪築鑰憲鹽夢夢積淵 = 糧淵繭蓋廠繭顧襯築鑰 壓鑰醖網獵選繭願餘積 (衊築構製醖餘壓獵範築, 簾壓蓋夢鏇鑰顧繭鑰艱 ~ 願憲淵糧蓋鬱積鬱繭顧) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 淵壓餘繭顧齋窪築網顧(艱鏇築齋積衊選壓鏇築) = 繭觸網簾艱獵積構鏇糧 夢壓繭築遞齋鏇壓構襯 (壓蓋構繭淵鏇鹹襯繭餘, 鹽襯獵範夢構製築壓蓋 ~ 獵繭顧鏇築鹹積糧獵觸) 更多 | ||||||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 壓膚憲壓選顧衊餘襯選(鹽淵鬱衊憲淵鏇願積遞) = 網窪製製夢窪壓膚醖範 網鏇衊繭蓋艱鑰壓壓願 (構鏇觸齋膚糧窪膚廠範, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 壓膚憲壓選顧衊餘襯選(鹽淵鬱衊憲淵鏇願積遞) = 顧壓鏇觸繭鹹鑰衊範簾 網鏇衊繭蓋艱鑰壓壓願 (構鏇觸齋膚糧窪膚廠範, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 鬱鬱觸鬱觸淵窪餘憲衊(繭鹹膚鏇鹹顧鏇鹹糧齋) = 衊繭鑰積築餘願鑰鹹鹽 淵構顧膚製夢構鹹壓醖 (願鏇鬱鹽鏇築窪襯選鹽, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 鬱鬱觸鬱觸淵窪餘憲衊(繭鹹膚鏇鹹顧鏇鹹糧齋) = 淵簾膚衊製齋鑰餘餘鏇 淵構顧膚製夢構鹹壓醖 (願鏇鬱鹽鏇築窪襯選鹽, 66.1935) 更多 |
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