Evaluation of the Effect of Fines in Powder Blends in Combination with a Novel Capsule-based Dry Powder Inhaler Device.
Introduction:
Dry powder inhalers (DPI) depend critically on the interplay between device and formulation. The influence of particle size parameters on the interaction between the active ingredient and excipients is well known, and requires fine tuning for each product, to achieve efficient lung deposition with the selected device [1]. Process parameters, such as blending time, speed and high or low shear blending, have been studied for their impact on performance [2]. It is well known that the addition of fine lactose to coarse lactose improves the formulation performance, i.e., Fine Particle Dose (FPD), Fine Particle Fraction (FPF) of a DPI formulation [3].
In this study, we demonstrate that the fluticasone propionate/salmeterol formulation originally delivered with Diskus device can be re-engineered into a capsule-based formulation. A PowdAir® Plus prototype with modified airflow resistance to match that of the Diskus Device was developed and tested with several different lactose blends to replicate the performance of the Seretide formulation with the new device.
Ameet Sule1, Tristan Mul2, Sunita Sule1, Julia Evers2, Mirjam Kobler1, Arslan Khan1.
1Presspart Manufacturing Limited, Blackburn, BB15RF
2MEGGLE GmbH & Co. KG, Megglestraße 6-12, 83512 Wasserburg
Poster request: Fines in DPI Blends with a Novel Capsule Device
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