M. Lebelle et al., METERED-DOSE INHALERS .1. DRUG CONTENT AND PARTICLE-SIZE DISTRIBUTIONOF BECLOMETHASONE DIPROPIONATE, Journal of pharmaceutical and biomedical analysis, 14(7), 1996, pp. 793-800
Four commercially available beclomethasone metered dose inhalers were
analyzed for both spray content uniformity and par-tide size. The drug
contents of primed and unprimed sprays collected at the beginning of
the lifetime of the canister were not significantly different from tho
se collected throughout the experiment. Particle size analysis of the
four products using the Andersen Cascade Impactor Mark II showed that
the distribution profiles were not identical. An existing HPLC method
was modified to quantitate single sprays for content uniformity and to
measure the amount on an impactor stage for particle sizing.