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01 Oct 2020

Pulmonary Fate of Fluticasone: Challenges Met


The study by Günther Hochhaus and colleagues investigates fluticasone propionate (FP), a medication used in inhalers. It focuses on how pharmacokinetic (PK) studies can be used to understand FP’s effects in the lungs and determine if different inhaler products are equivalent, without always needing clinical trials.

Specifically, the research compares the PK of three FP dry powder inhaler (DPI) formulations. By using both non-compartmental and compartmental analysis, the study finds that PK data can reflect the in vitro characteristics of these formulations. This suggests that PK studies can provide valuable insights into the dose of FP available in the lungs, how long it stays there, and how it spreads throughout different lung regions. These factors are crucial in assessing if different FP inhalers are effectively the same in terms of their lung effects.

It also explores why PK studies could be a useful tool in deciding bioequivalence (BE) for FP inhalers. It explains that many factors, like the inhaler device, the drug itself, its formulation, and patient characteristics, influence how FP behaves in the lungs when inhaled through a DPI.

The authors argue that PK studies, especially measurements like the area under the FP plasma concentration time profile (AUC0–inf), can provide enough information to make informed decisions about BE. They note that other PK parameters like Cmax (maximum concentration) and tmax (time to reach maximum concentration) can help distinguish between formulations based on how long FP remains in the lungs.

In conclusion, the study underscores the role of additional ingredients in influencing how FP acts in the lungs. It also points out that differences in previous studies between PK and pharmacodynamic (PD) results likely stem from FP’s dose-response characteristics and the limitations of PD studies in detecting differences between inhaler products.

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