APSD Work with PQRI
Cascade impaction testing and profile comparisons of aerodynamic particle size distributions (APSDs) of aerosol drug products were addressed through the Product Quality Research Institute (PQRI), in which IPAC-RS actively participated along with other representatives from the industry, academia, FDA and USP.
The APSD Profile Comparisons Working Group of PQRI has carried out a systematic investigation of a number of statistical approaches that had been proposed by the Agency for in vitro determinations of APSD equivalence. This Working Group has made a number of public presentations at scientific conferences, presented posters, and published several papers, the main ones being:
The Cascade Impaction Mass Balance Working Group of PQRI, has reported on its work and findings in the Journal of Aerosol Medicine:
- the "Good Cascade Impactor Practices" paper ( Considerations for the Development and Practice of Cascade Impaction Testing Including a Mass Balance Failure Investigation Tree. J. Aerosol Medicine, Vol. 16, No. 3, pp. 235-247 (2003) with a follow-up letter in J Aerosol Med. 16 (4):433), and
- Comparison of Two Approaches for Treating Cascade Impaction Mass Balance Measurements J. Aerosol Med. Vol.20, No. 3, pp 236-256 (2007).
Results of an earlier survey related to particle size testing, which was conducted by the ITFG/IPAC Collaboration, are summarized in a paper entitled, Initial Assessment of the ITFG/IPAC Aerodynamic Particle Size Distribution Database. That paper was submitted to the FDA in 2000. It suggests that orally inhaled products do not in general comply with the proposed mass balance requirement in the draft CMC Guidances, and that the proposed requirement is not suitable as a drug product specification.
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