Evaluation of the Effect of Fines in Powder Blends in Combination with a Novel Capsule-based Dry Powder Inhaler Device

Ameet Sule¹, Tristan Mul², Sunita Sule¹, Julia Evers², Mirjam Kobler¹, Arslan Khan¹.

¹Presspart Manufacturing Limited, Blackburn, BB15RF

²Meggle GmbH & Co., Megglestraße 6-12, 83512 Wasserburg

 Summary

 In this study, the correlation between Dry Powder Inhaler (DPI) formulation, device and performance was explored. Specifically, the impact of fine lactose particles on the aerodynamic particle size distribution (APSD) was investigated using a novel capsule based dry powder inhaler (medium resistance PowdAir Plus device). Two lactose grades, InhaLac^®180 (INH180) and InhaLac^®240 (INH240), were blended with different concentrations of micronized lactose InhaLac^®500 (INH500) using a high shear blender. These blends were characterized for particle size, morphology, and APSD. Formulations of Fluticasone Propionate (FP) and Salmeterol (S) with these lactose blends were tested for APSD and were compared with a marketed blister-based multidose DPI, Seretide Diskus (SD) – reference listed drug (RLD). The study demonstrates how varying the percentage of fines in lactose blends can be used to modify APSD performance.