The main objective of this project was to investigate the potential of Kleptose Linecaps DE17 (a pea maltodextrin with a DE range of 15 – 20) in masking the bitter taste of antifungal drug, griseofulvin (GRI) by Hot Melt Extrusion (HME) and to formulate a reconstitutable suspension for pediatric/geriatric patients. The taste masking of bitter APIs is a major challenge especially for pediatrics formulations.
Various reported approaches include, fluidized-bed coating, complexing agents, Pro-drug approach, etc. However, there is an enormous need for more robust, cost effective and easy to scale-up taste masking technologies. Hot Melt Extrusion (HME) is a continuous, one step process which also has been introduced for taste masking purposes of bitter APIs by involving the use of taste masking polymers that create solid dispersions to prevent bitter drugs from coming in contact with the patient’s taste buds.