Demonstrating bioequivalence for generic fluticasone propionate OINDPs

Optimal strategies for demonstrating bioequivalence for commonly used inhaled drugs are highly relevant to the cost-effective development of generics.

This paper considers the use of pharmacokinetics in the demonstration of the bioequivalence of fluticasone propionate inhalation products, without the need for comparative clinical endpoint studies. Compartmental and non-compartmental pharmacokinetic analyses for three alternative fluticasone dry powder inhaler formulations are examined. These data showed good agreement with formulation characteristics measured using in vitro methods and highlight the potential to use pharmacokinetic studies to assess the dose accessible to the lungs, regional deposition, and pulmonary residence time. The work illustrates how batch-to-batch differences in adjuvant or excipient properties influence pharmacokinetics, providing helpful guidance for those developing generic products.