Abstract

Hot-melt extrusion (HME), a continuous pharmaceutical manufacturing process, has gained significant importance within the last few decades. It entails the process of pumping raw material at relatively high temperatures and pressures resulting in a product of uniform shape and density, many times to increase the dissolution profile of poorly water soluble drugs by converting it into an amorphous form. ¹³ Thus, HME has emerged as an alternative “platform technology” to other conventional techniques for production of pharmaceutical dosage forms, such as tablets, capsules, films, and implants for drug delivery via the oral, transdermal, and transmucosal routes. ^2–7 This technology holds significant applications in several pharmaceutical areas, which remain yet unresolved by traditional pharmaceutical techniques. ⁴ To date, several research articles have been published describing the use of HME as a novel technique of choice to deal with day-to-day formulation challenges of new active pharmaceutical ingredients (API) by dispersing it with polymers and/or lipids at the molecular level, thus forming solid dispersions (or solutions).