Dry-powder inhalers: evaluation of testing methodology and effect of inhaler design.

We have previously developed a spray dried formulation of a model protein (beta-galactosidase) of a size suitable for evaluation in dry powder inhaler devices. In this study, we wished to evaluate the roles of various methods available for the laboratory testing of dry powders for inhalation (cascade impactor, twin impinger, aerodynamic time of flight and image analysis). Secondly we wished to compare different inhaler devices using formulations with and without a carrier. Both the cascade impactor and twin impinger were appropriate methods for the testing of dry powder inhalers, and gave comparable estimates of respirable fraction. Image analysis and aerodynamic time of flight were suitable methods for determining the particle size of the dry powders, although the former was considerably more time consuming than the latter. The four inhalers evaluated differed greatly in terms of in vitro deposition properties. The presence of a carrier significantly improved respirable fraction with the poorer inhalers, but was less critical to the performance of the more efficient devices.