DOI: 10.36347/sajp.2020.v09i06.002

Pages: 175-182

Hot Melt Extrusion technology offers an opportunity to acquire intellectual property, evident from the increasing number of patents and publications that have integrated it as an emerging pharmaceutical formulation technology over the last decades. Industrial adaptability has allowed hot-melt extrusion (HME) to gain wide recognition over the last decades and has already established its place in a wide range of manufacturing operations and advancements in pharmaceutical research. This study addressed the importance of the use of a quality-based strategy, based on a holistic approach to equipment, materials processing methods, novel formulation design and advancements, and its various applications for oral drug delivery systems. In drug discovery and development, the industry estimates that more than 50% of the active pharmaceutical ingredient used is part of the Biopharmaceutical Classification System II, defined as water-insoluble compounds, leading to formulations having less bioavailability. The pharmaceutical industry needs to develop formulations that will improve the solubility and ultimately the bioavailability of these compounds. Hot Melt Extrusion has already been shown to be robust, novel and powerful technique for improved bioavailability as well as taste masking of bitter active pharmaceutical ingredients (APIs). This paper examines the many benefits of Hot Melt Extrusion, based on a holistic approach to equipment, material processing methods, novel design and advancements.