Oral Controlled Drug Delivery by Hot-Melt Extrusion Technology

Hot-melt extrusion (HME) technology is rapidly growing in the pharmaceutical industry over recent years to provide the industry's most groundbreaking drug delivery technologies. Considering the continuously changing regulatory requirement where there is a constant demand for high production efficiencies with cost-saving and superior product quality, this well-established technology provides easy scale-up and process optimization. Controlled drug delivery systems (CDDS) offer a once-daily dose that is sufficient to maintain consistent plasma levels and provide maximal therapeutic value. Extruded CDDS have been proven effective for oral delivery. The objective of this chapter is to provide a pragmatic guide for research formulators to adapt in making formulation decisions and to understand the HME processing condition at a molecular level. This chapter presents the journey and evolution of CDDS along with case studies utilizing HME, offering myriad solutions for healthcare benefits. This chapter also highlights the specific challenges faced in the development of CDDS.