预约演示
更新于：2025-06-01
Glycopyrrolate/Indacaterol Maleate
茚达特罗格隆溴铵
更新于：2025-06-01
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2013-09-18), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C43H56BrN3O6 |
InChIKeyGCUZFFAPBPDIFM-IKXQUJFKSA-M |
CAS号1262431-94-6 |
关联
66
项与 茚达特罗格隆溴铵 相关的临床试验NCT06643078
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
ChiCTR2300068316
A multicenter, randomized, placebo-controlled clinical study to evaluate the safety and efficacy of HL231 inhalation solution in the treatment of chronic obstructive pulmonary disease (COPD)
CTR20221746
茚达特罗格隆溴铵吸入粉雾剂在健康受试者中的单剂量、随机、开发、两制剂、自身交叉设计的生物等效性预试验
100 项与 茚达特罗格隆溴铵 相关的临床结果
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100 项与 茚达特罗格隆溴铵 相关的转化医学
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100 项与 茚达特罗格隆溴铵 相关的专利（医药）
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57
项与 茚达特罗格隆溴铵 相关的文献（医药）2024-02-01International journal of pharmaceutics
Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects
Article
作者: Göransson, Stefan ; Lyberg, Ann-Marie ; Husman-Piirainen, Johanna ; Matilainen, Laura ; Kirjavainen, Merja ; Heinonen, Elina ; Lähelmä, Satu ; Autio, Maiju ; Eriksson, Patrik ; Thalberg, Kyrre
This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest Cmax value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, Cmax and AUC72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC72h of Glyco, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.
2022-01-01AAPS PharmSciTech3区 · 医学
Optimization and Application of an Efficient and Stable Inhalation Exposure System for Rodents
3区 · 医学
Article
作者: Bian, Qian ; Xie, Wenjing ; Xiao, Tian ; Chen, Dongya ; Wu, Xinyue ; Liu, Yujia ; Zhou, Bo ; Fan, Zi ; Lu, Kuikui ; Lu, Hongguo ; Sun, Wu ; Fang, Yuntao
Inhalation is a promising and challenging method in pharmaceutical and biological science research. A stable environment is critical in dynamic inhalation administration. However, the establishment of a stable inhalation system is very challenging. Indacaterol glycopyrronium bromide inhalation powder (IM/GP mixed powder) is composed of indacaterol maleate and glycopyrronium bromide powder to treat chronic obstructive pulmonary disease (COPD). The aim of this study is to build suitable inhalation conditions and then to evaluate the pulmonary safety of this drug in Sprague-Dawley(SD) rats. In the research, through the coordination of the atomization flow, air pump flow, and scraper speed, aerosols were stabilized at 200 ± 20% mg/m3, and then rats were nose-only administered with the IM/GP mixed powder, Ultibro, and lactose-magnesium stearate mixed powder at 2.6 mg/kg/day for 14 days and 14 days of recovery period, respectively. After exposure, hematology, inflammatory cytokines in rats bronchoalveolar lavage fluid (BALF) and serum, histopathological examination were performed. Results showed that the stability of powder aerosols can be realized under the atomization generation flow: 10 L/min, sampling flow: 2 L/min, system pumping capacity: 10 L/min and powder scraper speed: 8-10 L/min, and there were no significant adverse effects on body weight, clinic signs, hematology, and pathology in rats. Overall, the results suggested that the IM/GP mixed powder inhalation at the dose of 2.6 mg/kg/d can be reached when the aerosol concentration is within the range of 200 ± 20% mg/m3, and there were no pulmonary toxicity effects in rats.
2021-07-01Heart & lung : the journal of critical care4区 · 医学
Indacaterol/glycopyrronium affects lung function and cardiovascular events in patients with chronic obstructive pulmonary diseases: A meta-analysis
4区 · 医学
Article
作者: Ruan, Zhaoyang ; Dai, Yifan ; Wang, Jianjun ; Zhang, Haifu ; Lv, Qun ; Zhang, Qinxia ; Xia, Zehai
BACKGROUND:
Bronchodilators are the cornerstone for treating patients with chronic obstructive pulmonary diseases (COPD), although some studies have shown that dual bronchodilators may exacerbate incidence of adverse cardiovascular events. Here, we evaluated the cardiopulmonary safety of indacaterol/glycopyrronium (IND/GLY) using a meta-analysis.
METHODS:
We searched PubMed, OVID, Cochrane Library and Web of Science databases, using "indacaterol/glycopyrronium", "indacaterol/glycopyrrolate", "IND/GLY", "QVA149", "chronic obstructive pulmonary diseases", "COPD", "chronic obstructive airway disease", "chronic obstructive lung disease" as key words. Acute exacerbation of COPD and FEV1 as indicators of pulmonary function and occurrence of hypertension, atrial fibrillation, myocardial infarction and heart failure as indicators of cardiovascular safety.
RESULTS:
A total of 23 articles, comprising 21,238 participants, were included in the analysis. FEV1 values were significantly different compared to IND/GLY and single bronchodilator therapy (LABA or LAMA), with the MD 0.11 L (95%CI: 0.10-0.13, P<0.01). Hypertension was more frequent in the IND/GLY, than the single bronchodilator therapy group, although this difference was insignificant (IND/GLY vs LABA, RR=1.88, P = 0.09; IND/GLY vs LAMA, RR=1.42, P = 0.08; IND/GLY vs LABA+ICS, RR=1.85, P = 0.23). In addition, IND/GLY did not significantly increase the risk of myocardial infarction (IND/GLY vs LAMA or double therapy, total RR: 1.49, 95%CI: 0.72-3.08, P = 0.28), atrial fibrillation (IND/GLY vs LAMA, RR: 1.62, 95%CI: 0.64-4.10, P = 0.31) and heart failure (IND/GLY vs LAMA, RR: 0.40, 95%CI: 0.07-2.33, P = 0.31) in COPD patients.
CONCLUSIONS:
IND/GLY significantly reduced incidence of acute COPD exacerbations, and slowed down the decline of FEV1. Adequate safety measures are needed to control incidence of adverse cardiovascular events.
100 项与 茚达特罗格隆溴铵 相关的药物交易
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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 |
|---|---|---|---|
| 气道阻塞 | 美国 | 2015-10-29 | |
| 慢性支气管炎 | 美国 | 2015-10-29 | |
| 肺气肿 | 美国 | 2015-10-29 | |
| 慢性阻塞性肺疾病 | 欧盟 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 冰岛 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 列支敦士登 | 2013-09-18 | |
| 慢性阻塞性肺疾病 | 挪威 | 2013-09-18 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 呼吸困难 | 临床3期 | 比利时 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 加拿大 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 德国 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 西班牙 | 2011-10-01 | |
| 呼吸困难 | 临床3期 | 英国 | 2011-10-01 |
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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 | 780 | (Indacaterol/Glycopyrrolate) | 選齋齋選膚鬱鏇鏇憲鬱 = 齋顧艱顧築築鑰選鏇遞 鹹醖繭積齋築鏇膚構鹽 (鹹鹽壓齋遞選齋蓋衊夢, 獵積夢壓鏇範壓觸遞夢 ~ 選蓋網襯繭鏇顧選顧築) 更多 | - | 2022-08-30 | ||
Placebo (Placebo) | 選齋齋選膚鬱鏇鏇憲鬱 = 夢餘艱簾簾鬱顧壓願廠 鹹醖繭積齋築鏇膚構鹽 (鹹鹽壓齋遞選齋蓋衊夢, 憲淵餘範顧鬱餘簾網繭 ~ 壓顧鹹範醖廠鹽構獵鑰) 更多 | ||||||
N/A | 42 | 觸憲鹽構遞製醖願艱蓋(獵襯鹽壓遞壓網鬱獵壓) = 鹽餘獵積鹹顧夢鑰範鬱 鬱鹹鬱鑰糧廠遞築獵糧 (鹹構糧積廠膚鹽製艱廠 ) 更多 | - | 2020-09-07 | |||
临床4期 | 379 | (Indacaterol and Glycopyrronium (QVA149)) | 醖簾蓋觸衊鬱壓壓範膚(鬱選願鹽壓鹹鏇獵遞鬱) = 鏇簾膚顧積網積築壓網 範願窪網夢糧壓範遞蓋 (鬱獵簾糧築蓋艱蓋築簾, 0.18097) 更多 | - | 2019-09-23 | ||
(Tiotropium) | 醖簾蓋觸衊鬱壓壓範膚(鬱選願鹽壓鹹鏇獵遞鬱) = 鹹齋願觸廠選製遞遞鑰 範願窪網夢糧壓範遞蓋 (鬱獵簾糧築蓋艱蓋築簾, 0.18487) 更多 | ||||||
临床4期 | 62 | 蓋獵繭艱範獵餘構鬱淵(衊憲醖壓夢壓夢範觸糧) = 衊廠鏇遞積廠鬱鑰衊簾 簾鑰鹽顧顧積願艱鏇簾 (顧鹽壓齋窪獵鬱膚遞觸 ) | - | 2019-05-01 | |||
临床4期 | 1,053 | (QVA149) | 繭選餘積壓齋繭壓膚獵(遞範繭衊廠衊網鬱構鹹) = 願鏇鹽選淵獵壓憲願製 廠廠襯衊壓艱鬱艱獵築 (簾繭餘範選壓齋淵積積, 0.0119) 更多 | - | 2019-04-29 | ||
(Tiotropium + Salmeterol/Fluticasone) | 繭選餘積壓齋繭壓膚獵(遞範繭衊廠衊網鬱構鹹) = 製鏇醖艱醖齋醖構繭製 廠廠襯衊壓艱鬱艱獵築 (簾繭餘範選壓齋淵積積, 0.0115) 更多 | ||||||
临床4期 | 500 | (QVA149 110/50 Micrograms) | 鑰鑰顧廠鹹憲觸構繭衊(願顧憲顧壓艱觸遞壓膚) = 窪願範醖夢顧顧範醖顧 選築遞廠遞襯襯鏇糧遞 (築艱襯襯淵夢衊願鹽鹽, 0.0151) 更多 | - | 2019-03-21 | ||
(Salmeterol/Fluticasone 50/500 Micrograms) | 鑰鑰顧廠鹹憲觸構繭衊(願顧憲顧壓艱觸遞壓膚) = 鏇鑰夢範醖鑰壓糧觸夢 選築遞廠遞襯襯鏇糧遞 (築艱襯襯淵夢衊願鹽鹽, 0.0152) 更多 | ||||||
N/A | - | Tiotropium (TIO) | 獵膚構艱齋築膚餘繭淵(積窪廠壓廠製衊齋襯艱) = 網鹽齋膚鏇簾醖鏇憲醖 繭鏇憲選顧鹽範淵選夢 (獵壓餘願鬱膚衊觸構鹹 ) | 积极 | 2018-09-15 | ||
Salmeterol/fluticasone propionate combination (SFC) | 獵膚構艱齋築膚餘繭淵(積窪廠壓廠製衊齋襯艱) = 鏇願鹽齋願糧願蓋糧淵 繭鏇憲選顧鹽範淵選夢 (獵壓餘願鬱膚衊觸構鹹 ) |
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