Spiked Systems for Colonic Drug Delivery: Architectural Opportunities and Quality Assurance of Selective Laser Sintering.

Abstract

Additive manufacturing has been a breakthrough therapy for the pharmaceutical industry raising opportunities for long-quested properties, such as controlled drug-delivery. The aim of this study was to explore the geometrical capabilities of selective laser sintering (SLS) by creating spiked (tapered-edged) drug-loaded specimens for administration in colon. Poly(vinyl alcohol) (PVA) was used as the binding material and loperamide hydrochloride was incorporated as the active ingredient. Printing was feasible without the addition of a sintering agent or other additives. Innovative printing protocols were developed to help improve the quality of the obtained products. Intentional vibrations were applied on the powder bed through rapid movements of the printing platform in order to facilitate rigidity and consistency of the printed objects. The drug-loaded products had physicochemical properties that met the pharmacopoeia standards and exhibited good biocompatibility. The behavior of spiked balls (spherical objects with prominent spikes) and their retention time in the colon was assessed using a custom ex vivo intestinal setup. The spiked balls showed favorable mucoadhesive properties over the unspiked ones. No movement on the tissue was recorded for the spiked balls, and specimens with more spikes exhibited longer retention times and potentially, enhanced bioavailability. Our results suggest that SLS 3D printing is a versatile technology that holds the potential to revolutionize drug delivery systems by enabling the creation of complex geometries and medications with tunable properties.