Using pharmacokinetics to confirm bioequivalence in fluticasone DPIs

Streamlining the complexities of confirming the bioequivalence of generic orally inhaled drug products by would be helpful in reducing the costs of widely used respiratory therapeutics.

This paper describes pharmacokinetic studies of three fluticasone propionate dry powder inhaler formulations with respect to their effectiveness in detecting differences in regional deposition. The formulations were chosen for their ability to deliver deposition in different areas of the lung while at the same time ensuring a comparable overall dose. Systemic pharmacokinetics were assessed in a randomized, double-blind, four-way, crossover study, with 24 healthy volunteers. The results support the use of pharmacokinetic studies to provide relevant data for the assessment of pulmonary performance via parameters such as regional deposition, available dose, and residence time.