Wauthoz Nathalie, Hennia Ismaël, Dejaeger Bieke, Ecenarro Susana, Amighi Karim
Laboratoire de Pharmacie Galénique et de Biopharmacie, Université libre de Bruxelles (ULB), Brussels, Belgium.
Chimie analytique instrumentale et Bioélectrochimie, Université libre de Bruxelles (ULB), Brussels, Belgium.
Int J Pharm. 2017 Sep 15;530(1-2):415-429. doi: 10.1016/j.ijpharm.2017.07.021. Epub 2017 Jul 27.
Healthcare professionals require an easy algorithm for selecting the most appropriate inhalation product for each patient at the beginning of a treatment. As a case study, we selected five marketed formoterol products: Foradil and Formagal, capsule-based dry powder inhalers (DPIs), Novolizer Formoterol and Oxis, reservoir-based DPIs and Formoair, a pressurized metered dose inhaler. We generated an algorithm based on device properties (i.e. device handling, feedback and remaining dose/end of product indication) and in vitro aerodynamic performances (i) along the product use life in optimal conditions, (ii) at different airflows and (iii) after exposing pre-loaded doses to 40°C and 75% relative humidity for 4h. Based on these results, an algorithm was built where Formoair and Formagal can be proposed when there is high risk of humidity and for patients presenting suboptimal or optimal airflows. When no risk of humidity is present, Formoair, Foradil, Formagal and Novolizer Formoterol equipped with a trigger valve could be proposed for patients presenting suboptimal airflows. When no risk of humidity is present and for patients presenting optimal airflow, all products, including Oxis, could be proposed. Ultimately, the optimal inhalation product will be selected after checking the patient's preference and capacity for correct device handling and inhalation technique.
医疗保健专业人员需要一种简单的算法,以便在治疗开始时为每位患者选择最合适的吸入产品。作为一个案例研究,我们选择了五种市售的福莫特罗产品:Foradil和Formagal,基于胶囊的干粉吸入器(DPI);Novolizer Formoterol和Oxis,基于储库的DPI;以及Formoair,一种压力定量吸入器。我们基于装置特性(即装置操作、反馈和剩余剂量/产品使用期限)以及体外空气动力学性能生成了一种算法,体外空气动力学性能包括:(i)在最佳条件下沿产品使用寿命的性能;(ii)在不同气流下的性能;(iii)将预装剂量在40°C和75%相对湿度下暴露4小时后的性能。基于这些结果,构建了一种算法,当存在高湿度风险时,以及对于气流次优或最佳的患者,可以推荐使用Formoair和Formagal。当不存在湿度风险时,可以为气流次优的患者推荐配备触发阀的Formoair、Foradil、Formagal和Novolizer Formoterol。当不存在湿度风险且对于气流最佳的患者,可以推荐所有产品,包括Oxis。最终,在检查患者的偏好以及正确操作装置和吸入技术的能力之后,将选择最佳的吸入产品。