Development of Zero-Order Sustained-Release Capsules Containing Hot Melt Extruded Flurbiprofen-Loaded Pellets

Background and Aims: The aim of this study was to develop flurbiprofen-loaded pharmaceutical filaments using the HME technique, transform the filaments into pellets of appropriate size for capsule filling, and compare the drug release profile of the capsules with commercially available extended-release flurbiprofen capsules in the Turkish market. This study offers significant potential for industrial applicability and scalability by using the HME technique as an innovative production method and improving the solubility and release profile of flurbiprofen.Methods: Flurbiprofen-loaded filaments were fabricated using the HME technique at 110°C. Filaments were characterised through thermal, molecular, and crystallinity analyses. Drug release studies were systematically conducted in comparison with commercially available flurbiprofen preparations.Results: Filaments were successfully obtained using the HME technique. The excipients incorporated into the formulations were confirmed to be compatible with flurbiprofen. DSC and XRD analyses showed the transformation of flurbiprofen into an amorphous form. The F2 formulation demonstrated compliance with zero-order release kinetics and exhibited a dissolution profile comparable to that of commercial preparations.Conclusion: In this study, flurbiprofen-loaded filaments were produced via the HME technique, filled into capsules, and compared with four commercial flurbiprofen capsules. The F2 formulation exhibited a release profile similar to commercial products, following zero-order kinetics. The findings revealed the feasibility of the HME technique for developing capsule dosage forms through filament production, while indicating that the F2 formulation could be considered an alternative to commercial preparations.