Analytical Technology to Improve the Efficiency of a Through-Life Analysis on DPI Products
Stefano Campo1, Lorena Gasparini1, Federica Polimeni1, Tatiana Salvo1
1CMC, Drug Product Development Department, Chiesi Farmaceutici, Largo Belloli 11/A – 43122 – Parma – Italy
Summary
A through-life (TL) analysis consists of the determination of Fine Particle Mass (FPM) by Next Generation Impactor (NGI) and Mean Delivered Dose (MDD) by Dosage Unit Sampling Apparatus (DUSA) during the entire life of a device. In order to minimize the electrostatic charges due to device handling during the standard regimen, the waste shots are fired manually with the completion of a TL requiring more than one day, where a specific number of doses are collected per day. The aim of the study was to improve the efficiency of a TL analysis in terms of timing and analytical resources by automating the analytical procedure, but assuring good data quality. For this aim, the automatic workstation Xelair® 1 Series was implemented in Chiesi laboratories. It is an automatic equipment manufactured by Astech Projects and specifically customized in order to perform the waste shots of Dry Powder Inhaler (DPI) products filled in NEXThaler® devices. For this study a one day regimen was investigated analysing different DPI products and performing the waste shots with Xelair® 1 Series, equipped with a probe to reduce the electrostatic charges. The data quality was guaranteed by comparing the FPM, MDD and mean shot weights obtained with both the regimens which resulted comparable. By applying the one-day regimen using Xelair® 1 Series, improvement of efficiency in terms of analytical time was demonstrated to be ~40% per TL, while in terms of involved analytical resources, the time saving of a single analyst per TL was estimated to be ~25%.