Design and Development of Pulsatile Drug Delivery System of Bambuterol for Asthma Treatment

Aim/Background: The objective of this study was to create a pulsincap system designed to target the Gastrointestinal Tract (GIT) and administer the asthma drug bambuterol. Materials and Methods: In vitro release tests and Fourier-Transform Infrared Spectroscopy (FTIR) analysis were used to assess the physicochemical characteristics of Bambuterol Hydrochloride (BHC) granules. Based on these findings, the most promising formulation was selected for the pulsincap’s continued development. An in vitro assessment was subsequently conducted on the final pulsincap formulation. Results: The FTIR spectra confirmed the absence of any interaction between the polymer and BHC. Preformulation analyses demonstrated the granules possessed good flow characteristics. The in vitro release analysis of BHC granules showed rapid drug release, which was dependent on the dose of super disintegrants utilized; specifically, formulation F6, which contained 20 mg of crospovidone, achieved a 95.65% release after 15 min. In the pulse formulation containing karaya gum and lactose (F6-P5), a 5-hr lag time was observed in the in vitro dissolution of BHC from the pulsincap. Conclusion: The study concluded that BHC granules can be effectively directed towards the GIT. The release of the medicine started after the 5-hr lag time, and 91.87% of the medicine had been released overall by the 9th hr.