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Novel approach for real-time monitoring of carrier-based DPIs delivery process via pulmonary route based on modular modified Sympatec HELOS

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Acta Pharmaceutica Sinica B 2020年第7期10卷 1331-1346页

作者： Xuejuan Zhang Yingtong Cui Ruifeng Liang Guanlin Wang Xiao Yue Ziyu Zhao Zhengwei Huang Ying Huang Jianfang Geng Xin Pan Chuanbin Wu School of Pharmaceutical Sciences Sun Yat-Sen UniversityGuangzhou 510006China Institute for Biomedical and Pharmaceutical Sciences Guangdong University of TechnologyGuangzhou 510006China School of Pharmaceutical Science Jinan UniversityGuangzhou 510006China Department of Pharmacology Zhongshan School of MedicineSun Yat-Sen UniversityGuangzhou 510080China Sympatec GmbH Suzhou Rep.Office Suzhou 215123China

An explicit illustration of pulmonary delivery processes(PDPs)was a prerequisite for the formulation design and optimization of carrier-based ***,the current evaluation approaches for DPIs could not provide precise investigation of each PDP separately,or the approaches merely used a simplified and idealized *** the present study,a novel modular modified Sympatec HELOS Real-time monitoring;Modular modification;Carrier;Air flow rate;Mechanism of drug delivery(MMSH)was developed to fully investigate the mechanism of each PDP separately in *** inhaler device,artificial throat and pre-separator were separately integrated with a Sympatec *** dispersion and fluidization,transportation,detachment and deposition processes of pulmonary delivery for model DPIs were explored under different flow ***,time-sliced measurements were used to monitor the PDPs in *** Next Generation Impactor(NGI)was applied to determine the aerosolization performance of the model *** release profiles of the drug particles,drug aggregations and carriers were obtained by MMSH in *** PDP of the DPIs was analyzed in ***,a positive correlation was established between the total release amount of drug particles and the fine particle fraction(FPF)values(R^2=0.9898).The innovative MMSH was successfully developed and was capable of illustrating the PDPs and the mechanism of carrier-based DPIs,providing a theoretical basis for the design and optimization of carrier-based DPIs.

关键词： Dry powder inhalation pulmonary delivery process

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A real-time and modular approach for quick detection and mechanism exploration of DPIs with different carrier particle sizes

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Acta Pharmaceutica Sinica B 2022年第1期12卷 437-450页

作者： Yingtong Cui Ying Huang Xuejuan Zhang Xiangyun Lu Jun Xue Guanlin Wang Ping Hu Xiao Yue Ziyu Zhao Xin Pan Chuanbin Wu School of Pharmaceutical Science Jinan UniversityGuangzhou 510006China School of Pharmaceutical Sciences Sun Yat-sen UniversityGuangzhou 510006China Micromeritics Instrument(Shanghai)Ltd”Shanghai 200135 China MEGGLE Group Shanghai Representative Office Shanghai 201315China Department of Pharmacology Zhongshan School of MedicineSun Yat-sen UniversityGuangzhou 510080China

Dry powder inhalers(DPIs) had been widely used in lung diseases on account of direct pulmonary delivery, good drug stability and satisfactory patient compliance. However, an indistinct understanding of pulmonary delivery processes(PDPs) hindered the development of DPIs. Most current evaluation methods explored the PDPs with over-simplified models, leading to uncompleted investigations of the whole or partial PDPs. In the present research, an innovative modular process analysis platform(MPAP) was applied to investigate the detailed mechanisms of each PDP of DPIs with different carrier particle sizes(CPS). The MPAP was composed of a laser particle size analyzer, an inhaler device,an artificial throat and a pre-separator, to investigate the fluidization and dispersion, transportation,detachment and deposition process of DPIs. The release profiles of drug, drug aggregation and carrier were monitored in real-time. The influence of CPS on PDPs and corresponding mechanisms were explored. The powder properties of the carriers were investigated by the optical profiler and Freeman Technology four powder rheometer. The next generation impactor was employed to explore the aerosolization performance of DPIs. The novel MPAP was successfully applied in exploring the comprehensive mechanism of PDPs, which had enormous potential to be used to investigate and develop DPIs.

关键词： Dry powder inhaler Carrier particle size pulmonary delivery process Real-time monitor Quick detection

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