Development of In Vitro Dissolution Test Method for Bilastine and Montelukast Fixed-Dose Combination Tablets

Abstract

Bilastine and montelukast are Biopharmaceutical Classification System (BCS) class II compounds with low bioavailability, especially when taken orally. It is challenging to develop a dissolution test. The purpose of this study is to select an in vitro dissolution test that would be useful for bilastine and montelukast solid oral dosage forms. Solid oral dosage forms containing bilastine and montelukast, for which in vivo data are available, were studied using different in vitro dissolution test conditions. Dissolution tests were performed under sink conditions in various non-biorelevant media with changes in various parameters like United States Pharmacopeia (USP) basket or paddle apparatus, rotation speed, volume of media, with different dissolution media. A novel high-performance liquid chromatography method was developed and validated to simultaneously estimate the dissolution profile. The optimal dissolution conditions for bilastine and montelukast are 900 mL 0.5% sodium lauryl sulphate (SLS) in water at 37 ± 0.5 °C and 75 rpm using the paddle apparatus.