Formulation variables affecting deposition with the Kchaler device, a novel multiple dose dry powder inhaler device

Abstract

The inhaler device is as important as the powder formulation for the successful development of dry powder inhalation products. As a result of current focus on tightening regulatory requirements, it is imperative that reproducibility of the metered dose of drugs be ensured during the formulation, packaging and use. We developed a dry powder inhalation package in our laboratories consisting of formulation mixes, design and a device, KCHALER, for Phase1 and Phase 2 Clinical studies. In this report, we present data on dose reproducibility obtained with the KCHALER device and the effect of type of mouthpiece and grid attached to the device on salbutamol deposition in the Twin Impinger BP.

Keywords: KCHALERTM device; dose reproducibility; effect of mouthpiece and grid; salbutamol disposition; Twin Impinger BP