Taste Masking of Bitter APIs by Using Hot-Melt Extrusion (HME)

Mohammed Maniruzzaman1, Joshua S Boateng1, Dennis Douroumis1

1University of Greenwich, School of Science, Central Avenue, Chatham Maritime, Chatham, Kent, ME4 4TB D.Douroumis@greenwich.ac.uk

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Summary
The purpose of this study was to investigate the potential of hot melt extrusion (HME) for masking the taste of bitter APIs when incorporated into different polymer formulations. Extrudates were produced by HME using five water soluble cationic model drugs processed with various grades of anionic polymers. The extrusion process was optimized using a single screw extruder to obtain and blend all starting materials to obtain extruadates with desirable characteristics. Results obtained from a panel of six healthy human volunteers demonstrated that the HME extruded formulations improved the taste significantly compared to that of the pure APIs itself. Furthermore, the extrudates characterized by X-ray and DSC studies showed the presence of APIs in amorphous or molecularly dispersed state while in vitro dissolution showed rapid release for all drug substances. Inc conclusion HME can be effectively used to mask the taste of bitter APIs by enhancing drug – polymer interactions.

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