ABSTRACT
The device or the formulation? Which one governs drug dispersibility from the inhaler? To address this question, three budesonide-containing reservoir DPIs: Novopulmon Novolizer®, Giona Easyhaler® and DuoResp Spiromax®, were analyzed using the Next Generation Impactor, NGI. Thereafter, the devices were carefully opened, emptied, and formulations were switched between devices. Finally, three 'prototype' formulations with carriers of different particle size were produced and tested in the Novolizer and Easyhaler devices. Among the DPI products, the two devices which have a flow path with a cyclone-type geometry, i.e., the Novolizer and the Spiromax, yielded a fine particle fraction, FPF, above 40%. The Easyhaler, which has a straight mouthpiece outlet, produced an FPF of 18%. When the Novopulmon and the DuoResp formulations were assayed in the Easyhaler device, poor fine particle fractions were obtained. To the contrary, the Giona formulation produced a high FPF when tested in the Novolizer device. The results clearly show that the device is the dominating factor to dispersibility for the investigated products. Along the same lines, all three 'prototype' formulations produced high fine particle fractions in the Novolizer device, with the formulation with the largest carrier giving the best performance. Tested in the Easyhaler device, the prototype formulations produced low fine particle fractions, but interestingly, the formulation with the smallest carrier particle size yielded the highest FPF. It can be concluded that there is a link between inhaler design and the effect of carrier particle size, where larger carriers provide better dispersion in cyclone-type devices while smaller carriers seem to be more beneficial for inhalers which has a straight flow path for the powder formulation.
