RESUMO
Seven independent testing sites received metered-dose aerosols containing a standard test solution to assess a newly designed protocol for studying the reproducibility of metered-dose aerosol valves. In accordance with the rather small sampling protocol design, the amount of product dispensed per actuation was measured over the life of the aerosol at designated regions of actuation. A statistical analysis of the data collected at each testing site clearly indicated that the testing protocol is sufficiently reliable and workable for assessing the reproducibility of valve delivery for a given lot of metered-dose valves.
Assuntos
Aerossóis/administração & dosagem , Aerossóis/normas , Administração por Inalação , Análise de Variância , Química Farmacêutica , Reprodutibilidade dos Testes , SoluçõesRESUMO
An in vitro technique was developed to characterize the intermittent flume patterns associated with the short bursts of metered-dose aerosols. Two orthogonal video images are utilized to describe the complex shape and direction of the flume pattern. This technique facilitates the evaluation of components manufactured by different suppliers.
