Pharmaceutical Product Assessment

The consideration of major importance in the use of various particle measurement techniques for the assessment of pharmaceutical aerosols is the method of sampling. Unlike most aerosols for which the sizing techniques were originally developed, pharmaceutical aerosols occur in very high concentrations in the carrier airstream. Additionally, the particle size may vary as a function of the position of sampling of the aerosol with respect to the generating orifice or mechanism. Because this is also the case when aerosols are presented to the patient for inhalation, the importance of the design of the sampling port may not be in obtaining the "absolute" or equilibrium particle or droplet size. It is, perhaps, of more significance to estimate the particle size of the aerosol as it would be presented to the patient or the lung. There are a variety of physiological parameters to consider in a true model of this situation. Thus, a pragmatic approach is to adopt a geometry for the sampling port that results in realistic estimates of the respirable fraction as defined by a correspondence with pulmonary deposition or bioequivalence studies. The sampling port does not necessarily require dimensions bearing any relationship to the upper respiratory tract [137]. This is still a topic of much debate that is unlikely to find its solution in a single method. As with most approaches to scientific discovery, the use of a number of methods will yield a broad database, enabling the investigator to make informed judgments with respect to optimizing the dosage form.

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