Non-conventional polymers as matrix excipients for hot melt extruded oral-release formulations

The objective of this doctoral thesis was to evaluate the use of several non-conventional polymers as matrix excipients for hot melt extruded oral-release formulations. Expanding the range of polymers currently used for HME/IM could potentially solve the problems associated with the current formulations: pH dependent release profiles, stability issues, and low drug loaded dosage forms. Moreover, formulations containing 3 components (active pharmaceutical ingredient (API), polymer and other additional excipient) have been extensively described in literature. If the characteristics of an extrudate containing API and polymer does not meet the requirements, a third component (plasticizer, drug release modifier, swelling agent, etc.) is often added to improve the formulation its performance. This doctoral thesis has the intention to emphasize the importance of the polymer. Try to ‘keep it simple’. The focus should first be on the polymer rather than on the addition of a third component. To this end, the process of HME could be simplified as a combination of 2 components requires less quality control, process control and decreases the complexity of formulation characterization. Overall, this doctoral thesis accentuates the need for a more rational design of polymer matrix excipients for drug formulation via HME and IM