Groß Roman, Berkenfeld Kai, Schulte Christoph, Ebert Anselm, Sule Sunita, Sule Ameet, Lamprecht Alf
Laboratory of Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy, University of Bonn, Gerhard-Domagk-Street 3, 53121 Bonn, Germany.
Presspart GmbH & Co. KG, Am Meilenstein 8-19, 34431 Marsberg, Germany.
Pharmaceutics. 2022 May 31;14(6):1185. doi: 10.3390/pharmaceutics14061185.
Commercially available dry powder inhalers (DPIs) are usually devices in a fixed combination with the intended formulation, and a change in medication by the physician often forces the patient to use a different device, requiring the patient to relearn how to use it, resulting in lower adherence and inadequate therapy. To investigate whether DPIs can achieve successful outcomes regardless of the formulation and flow rate used, a novel DPI and two commercially available devices were compared in vitro for their deagglomeration behavior for different binary blends and a spray-dried particle formulation. The results demonstrate that the novel device achieved the highest fine particle fraction (FPF) regardless of the formulations tested. In the binary mixtures tested, the highest emitted fraction was obtained by shaking out the powder due to the oscillating motion of the capsule in the novel device during actuation. For DPIs with high intrinsic resistance to airflow, similar FPFs were obtained with the respective DPI and formulation, regardless of the applied flow rate. Additionally, the development and use of binary blends of spray-dried APIs and carrier particles may result in high FPF and overcome disadvantages of spray-dried particles, such as high powder retention in the capsule.
市售的干粉吸入器（DPI）通常是与预期制剂固定组合的装置，医生改变用药往往会迫使患者使用不同的装置，这就要求患者重新学习如何使用，从而导致依从性降低和治疗不足。为了研究DPI是否无论使用何种制剂和流速都能取得成功的效果，对一种新型DPI和两种市售装置进行了体外比较，考察它们对不同二元混合物和喷雾干燥颗粒制剂的解聚行为。结果表明，无论测试何种制剂，新型装置都能实现最高的细颗粒分数（FPF）。在测试的二元混合物中，由于新型装置在启动时胶囊的振荡运动，通过抖出粉末获得了最高的喷出分数。对于对气流具有高固有阻力的DPI，无论施加何种流速，使用各自的DPI和制剂都能获得相似的FPF。此外，喷雾干燥的活性药物成分（API）与载体颗粒二元混合物的开发和使用可能会导致高FPF，并克服喷雾干燥颗粒的缺点，如胶囊中粉末保留率高。
