QbD Demands for Powder Inhalers of the Future: Addressing Dissolution During Product Development
Cooper AD, Ticehurst M, Jones RM.
Respiratory Drug Delivery 2012. Volume 1, 2012: 193-202.
Abstract:
Consideration of the Nernst-Brunner dissolution model suggests that in vivo dissolution rate may be a limiting factor in pulmonary release and systemic absorption of some low solubility inhaled drugs, even when these are micronized to respirable size. The pharmokinetic properties of some inhaled products are consistent with this conclusion. Therefore, development of powder inhalers within a Quality by Design (QbD) framework could potentially consider dissolution rate as a quality attribute. The implications for candidate selection, product design, development and control strategy are discussed in the light of available literature.
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