Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
Eur J Med Res. 2009 Dec 7;14 Suppl 4(Suppl 4):71-7. doi: 10.1186/2047-783x-14-s4-71.
In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional parameters. Beside its pharmacology the active agent is furthermore determined by its aerosol characteristics as particle diameter, particle density, hygroscopicity and electrical charge. The patient related factors like age and stage of pulmonary disease will be additionally affected by the individual breathing pattern and morphometry of the lower airways. A number of these parameters with essential impact on the pulmonary drug deposition can be influenced by the performance of the inhalation system. Therefore, the optimization of nebulisation technology was a major part of aerosol science in the last decade. At this time the control of inspiration volume and air flow as well as the administration of a defined aerosol bolus was in the main focus. Up to date a more efficient and a more targeted pulmonary drug deposition - e.g., in the alveoli - will be provided by novel devices which also allow shorter treatment times and a better reproducibility of the administered lung doses. By such means of precise dosing and drug targeting the efficacy of inhalation therapy can be upgraded, e.g., the continuous inhalation of budesonide in asthma. From a patients' perspective an optimized inhalation manoeuvre means less side effects, e.g., in cystic fibrosis therapy the reduced oropharyngeal tobramycin exposure causes fewer bronchial irritations. Respecting to shorter treatment times also, this result in an improved quality of life and compliance. For clinical trials the scaling down of dose variability in combination with enhanced pulmonary deposition reduces the number of patients to be included and the requirement of pharmaceutical compounds. This review summarises principles and advances of individualised controlled inhalation (ICI) as offered by the AKITA inhalation system.
在肺部疾病的治疗中,吸入疗法起着关键作用——它是哮喘、慢性阻塞性肺疾病(COPD)和囊性纤维化等疾病中药物输送的首选途径。但是,与口服和静脉给药相比,肺部药物输送受到其他参数的控制。除了药理学特性外,药物的活性成分还受到气溶胶特性的影响,如粒径、颗粒密度、吸湿性和电荷。患者相关因素,如年龄和肺部疾病阶段,还会受到个体呼吸模式和下呼吸道形态的影响。许多对肺部药物沉积有重要影响的参数可以通过吸入系统的性能来改变。因此,在过去十年中,雾化技术的优化是气溶胶科学的主要内容。在这一时期,吸气量和气流的控制以及定义的气溶胶团的给药成为主要关注点。目前,新型装置可以更有效地将药物靶向肺部沉积,例如在肺泡中,这也可以缩短治疗时间并提高肺部剂量的可重复性。通过这种精确给药和药物靶向的方法,可以提高吸入治疗的疗效,例如在哮喘中持续吸入布地奈德。从患者的角度来看,优化的吸入操作意味着更少的副作用,例如在囊性纤维化治疗中,减少的口咽妥布霉素暴露会减少支气管刺激。由于治疗时间缩短,患者的生活质量和依从性也会得到改善。对于临床试验,剂量变异性的缩小与肺部沉积的增强相结合,可以减少所需患者数量和药物化合物的要求。这篇综述总结了 AKITA 吸入系统提供的个体化控制吸入(ICI)的原理和进展。