UNASSIGNED:2013年在英国发现的伪造Symbicort320/9Turbohaler表明,伪造的干粉吸入器也存在于欧洲市场。这项工作旨在通过评估其空气动力学性能概况来调查欧洲和北非含福莫特罗干粉吸入器的现状。
UNASSIGNED:在欧洲和北非市场上,共有8个注册的基于福莫特罗的干粉吸入器参与了这项研究,包括参考药物Foradil.使用多级液体冲击器(MsLI)制备样品,并通过经验证的HPLC-UV方法进一步分析以确定递送的和细颗粒剂量(FPD)。这项研究还检查了冻融循环在分析目的处理方面对样品稳定性的影响。
UNASSIGNED:在参与这项工作的药品中没有发现不合格的干粉吸入器。评估药物的递送剂量(DD)从8.33到9.69µg不等,而FPD在1.86和3.35µg之间。不出所料,这项工作证实,胶囊成分和初级包装的阻隔性能会影响吸入用干粉的FPD。
未经批准:产品C和B的FPD为,分别,17.4%和14.2%优于Foradil,产品D和H与原始药物相比具有最接近的值,产品F劣质34.5%。此外,这项工作表明,使用HPMC胶囊和不透水的初级包装可以实现高FPD。
UNASSIGNED: Discovery of falsified Symbicort 320/9 Turbohaler identified in the UK in 2013 demonstrated that falsified dry powder inhalers were also present in the European market. This work aimed to investigate the current situation of formoterol-containing dry powder inhalers in Europe and North Africa by assessing their aerodynamic performance profile.
UNASSIGNED: A total of eight registered formoterol-based dry powder inhalers over the European and North African markets were involved in this study, including the reference drug Foradil. Samples were prepared using a multistage liquid impinger (MsLI) and further analyzed by a validated HPLC-UV method to determine the delivered and the fine particle doses (FPDs). This study also examined the impact of freezing-thawing cycles on sample stability in terms of analytical purpose handling.
UNASSIGNED: No substandard dry powder inhalers were identified among the medicinal products involved in this work. The delivered dose (DD) of assessed drugs varied from 8.33 to 9.69 µg, while the FPD was between 1.86 and 3.35 µg. As expected, this work confirmed that the capsule composition and the barrier properties of the primary packaging can affect the FPD of dry powder for inhalation use.
UNASSIGNED: The FPD of products C and B was, respectively, 17.4 and 14.2% superior to Foradil, products D and H had the closest values compared to the original drug, and product F was 34.5% inferior. Additionally, this work showed that a high FPD can be achieved using HPMC capsules and moisture-impermeable primary packaging.