Over the last three decades industrial adaptability has allowed hot-melt extrusion (HME) to gain wide acceptance and has already established its place in the broad spectrum of manufacturing operations and pharmaceutical research developments. HME has already been demonstrated as a robust, novel technique to make solid dispersions in order to provide time controlled, modified, extended, and targeted drug delivery resulting in improved bioavailability as well as taste masking of bitter active pharmaceutical ingredients (APIs). This paper reviews the innumerable benefits of HME, based on a holistic perspective of the equipment, processing technologies to the materials, novel formulation design and developments, and its varied applications in oral drug delivery systems. 1. Introduction To date HME has emerged as a novel processing technology in developing molecular dispersions of active pharmaceutical ingredients (APIs) into various polymer or/and lipid matrices which has led this technique to demonstrate time controlled, modified, extended, and targeted drug delivery [1–4]. HME has now provided opportunity for use of materials in order to mask the bitter taste of active substances. Since the industrial application of the extrusion process back in the 1930’s, HME has received considerable attention from both the pharmaceutical industry and academia in a range of applications for pharmaceutical dosage forms, such as tablets, capsules, films, and implants for drug delivery via oral, transdermal, and transmucosal routes [5]. This makes HME an excellent alternative to other conventionally available techniques such as roll spinning and spray drying. In addition to being a proven manufacturing process, HME meets the goal of the US Food and Drug Administration’s (FDA) process analytical technology (PAT) scheme for designing, analyzing, and controlling the manufacturing process via quality control measurements during active extrusion process [6]. In this chapter, the hot-melt extrusion technique is reviewed based on a holistic perspective of its various components, processing technologies, and the materials and novel formulation design and developments in its varied applications in oral drug delivery systems. 2. Process Technology of Hot-Melt Extrusion (HME) Hot-melt extrusion technique was first invented for the manufacturing of lead pipes at the end of the eighteenth century [7]. Since then, it has been used in the plastic, rubber, and food manufacturing industry to produce items ranging from pipes to sheets and bags. With the advent of high throughput screening,
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