Population Pharmacokinetics οf Fluticasone Propionate / Salmeterol Using Two Different Dry Powder Inhalers.

Population Pharmacokinetics οf Fluticasone Propionate / Salmeterol Using Two Different Dry Powder Inhalers. Eur J Pharm Sci. 2015 Aug 18; Authors: Soulele K, Macheras P, Silvestro L, Rizea Savu S, Karalis V Abstract The combination of fluticasone propionate (FLP) and salmeterol (SAL) is often used in clinical practice for the treatment of pulmonary disorders. The purpose of this study was to explore the pharmacokinetics (PK) of inhaled FLP and SAL, after concomitant administration, in healthy male and female subjects using two dry powder inhalers. Plasma concentration (C) - time (t) data were obtained from a single dose, two-sequence, two-period, crossover (2x2) bioequivalence (BE) study. Activated charcoal was co-administered in order to prohibit absorption from the gastrointestinal tract. A number of 60 subjects were recruited, while 57 of them completed the study and were included in the PK analysis. Initially, PK parameters of FLP and SAL were estimated using the classic non-compartmental methods. Subsequently, BE assessment was applied to the estimated PK parameters of the two dry powder inhalers. Special focus was placed on the population PK analysis of the C-t data, which were pooled together. 'Treatment' (i.e., test or reference) and 'period' of the BE study were considered as covariates. A variety of structural and residual error models were tested to find the one which best described the plasma C-t data of FLP and SAL. Dem...
Source: European Journal of Pharmaceutical Sciences - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharm Sci Source Type: research