Investigation of high pulmonary drug loading to the lung using a novel lactose grade with iDPC blending technology

Ross Blezard¹, Jasdip Koner², Timo Roelofs¹ Shital Lungare², Israth Hussain² and Manpreet Kaur²,  

¹DFE Pharma GmbH & Co. KG, Klever Str 187, Goch, 47574, Germany

²Aston Particle Technologies, Aston Triangle, Birmingham, B4 7ET, UK

Summary

Conventional dry powder inhalers (DPIs) typically deliver 5 to 500 µg of API . This dose is appropriate for the treatment of asthma and COPD.  However, treating a broader range of indications – such as vaccines, antibiotics, oncology and other systemically active drugs – may require higher pulmonary doses. While this can be achieved using novel technologies such as particle engineering and innovative device technologies, utilizing these technologies introduces a high regulatory burden and a greater degree of uncertainty.  This may reduce the appeal for further investment in the development of these medicines due to high commercialization costs. The aim of this study is to explore whether high drug loading, defined in this study as a fine particle dose greater than 1 mg using technologies with minimal novelty can be achieved. Specifically, lactose-based carrier technologies combined with existing and modified mixing technologies in a conventional capsule-based device.