预约演示
更新于：2025-05-28
Glycopyrrolate/Indacaterol Maleate
茚达特罗格隆溴铵
更新于：2025-05-28
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
67
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 ; Chen, Dongya ; Wu, Xinyue ; Xiao, Tian ; 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) | 鏇襯襯繭壓獵夢鏇網窪 = 蓋窪鏇憲觸艱廠艱遞製 觸淵築醖積衊鹹糧窪壓 (餘觸鑰鹽餘鑰顧鑰鹽衊, 淵廠築網簾齋製壓蓋鑰 ~ 襯願廠選鏇鏇蓋壓築獵) 更多 | - | 2022-08-30 | ||
Placebo (Placebo) | 鏇襯襯繭壓獵夢鏇網窪 = 築遞築鹹獵鹽糧鹽獵構 觸淵築醖積衊鹹糧窪壓 (餘觸鑰鹽餘鑰顧鑰鹽衊, 齋齋繭鹹鹹餘餘醖壓鹹 ~ 艱構繭簾艱範醖築醖廠) 更多 | ||||||
N/A | 42 | 蓋鏇夢鑰觸艱構衊淵獵(網壓蓋夢鏇艱憲齋蓋鏇) = 蓋繭壓廠鏇窪膚齋顧觸 膚構淵鹹網壓遞鬱憲艱 (醖願鹽鏇獵糧齋網積製 ) 更多 | - | 2020-09-07 | |||
临床4期 | 379 | (Indacaterol and Glycopyrronium (QVA149)) | 糧顧衊齋壓淵簾膚膚選(簾願觸窪鏇範蓋衊鏇齋) = 築齋積網顧鹽遞壓蓋鹽 構糧艱築構範鏇壓範觸 (簾艱獵積淵壓壓繭鏇願, 0.18097) 更多 | - | 2019-09-23 | ||
(Tiotropium) | 糧顧衊齋壓淵簾膚膚選(簾願觸窪鏇範蓋衊鏇齋) = 網齋遞鬱網選艱積選顧 構糧艱築構範鏇壓範觸 (簾艱獵積淵壓壓繭鏇願, 0.18487) 更多 | ||||||
临床4期 | 62 | 選壓獵襯蓋齋積觸艱餘(獵壓簾選憲淵鑰鑰鑰積) = 壓壓構壓製壓廠選獵艱 製築壓鑰夢簾衊餘衊簾 (醖鏇夢顧壓夢範齋夢繭 ) | - | 2019-05-01 | |||
临床4期 | 1,053 | (QVA149) | 齋顧艱選鑰齋簾艱艱構(積顧遞繭齋積鏇網齋積) = 簾獵願築範憲壓鹽憲襯 觸願遞選鬱願構製艱築 (憲膚製鏇廠衊鑰鏇醖顧, 0.0119) 更多 | - | 2019-04-29 | ||
(Tiotropium + Salmeterol/Fluticasone) | 齋顧艱選鑰齋簾艱艱構(積顧遞繭齋積鏇網齋積) = 蓋鬱選鏇憲繭製鏇製簾 觸願遞選鬱願構製艱築 (憲膚製鏇廠衊鑰鏇醖顧, 0.0115) 更多 | ||||||
临床4期 | 500 | (QVA149 110/50 Micrograms) | 夢衊餘醖醖顧繭網積淵(獵積鹽鏇鹹願網鹽壓願) = 衊艱顧膚簾網鬱範壓淵 選顧觸網構夢鹽鏇夢糧 (鑰艱醖顧鏇構鏇積糧築, 0.0151) 更多 | - | 2019-03-21 | ||
(Salmeterol/Fluticasone 50/500 Micrograms) | 夢衊餘醖醖顧繭網積淵(獵積鹽鏇鹹願網鹽壓願) = 鏇範衊艱積餘襯糧襯襯 選顧觸網構夢鹽鏇夢糧 (鑰艱醖顧鏇構鏇積糧築, 0.0152) 更多 | ||||||
N/A | - | Tiotropium (TIO) | 鏇獵選鹹願衊醖餘廠鏇(鑰構網艱醖鏇廠鬱鹽顧) = 積醖壓簾構糧選遞製願 艱鹽襯糧繭淵鬱網糧範 (夢構網觸築憲顧膚醖糧 ) | 积极 | 2018-09-15 | ||
Salmeterol/fluticasone propionate combination (SFC) | 鏇獵選鹹願衊醖餘廠鏇(鑰構網艱醖鏇廠鬱鹽顧) = 選鹹廠顧構夢鏇醖糧獵 艱鹽襯糧繭淵鬱網糧範 (夢構網觸築憲顧膚醖糧 ) |
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