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

TL;DR

This paper explores using 3D printing to create spiked drug delivery systems for the colon, showing improved retention and bioavailability.

Contribution

The study introduces spiked geometries in drug-loaded systems using SLS 3D printing without additives, enhancing colon retention and bioavailability.

Findings

Spiked drug-loaded specimens met pharmacopoeia standards and showed good biocompatibility.

Spiked balls exhibited longer retention times and better mucoadhesive properties compared to unspiked ones.

Innovative printing protocols improved product quality without sintering agents.

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.

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