Background: Eosinophilic esophagitis (EoE) is an emerging chronic allergic disease characterized by eosinophilic infiltration of the esophageal mucosa. The most common symptoms of EoE include heartburn, feeding intolerance, dysphagia, and food impaction. EoE represents a major healthcare burden as the estimated prevalence is at least 1 in 2000 Americans, and EoE associated healthcare costs are about $1.4 billion per year. Because there are no FDA approved treatments for EoE, patients are prescribed asthma preparations such as fluticasone in an inhaler. This rudimentary approach leads to poor outcomes and low compliance. To address these limitations, we report the development of an esophageal-specific drug delivery platform, a drug-eluting 3D printed biodegradable ring, for a local and sustained release of fluticasone in the esophagus.<br/>Methods: In this work, we have designed and fabricated biocompatible and biodegradable fluticasone loaded rings using a top-down, Digital Light Processing (DLP) Gizmo 3D printer (Figure 1). 3D printed rings were fabricated by dissolving fluticasone into polycaprolactone-dimethacrylate (PCL-DMA) resin formulations at 1.4% w/w (fluticasone:resin) at a target dose of 1-2mg/day<br/>Results: In vitro drug release studies of fluticasone loaded rings showed that fluticasone elutes at zero order release kinetics, and the addition of diluent to PCL-DMA slowed down the drug release (50% in 18 weeks) compared to the higher crosslinked 100% PCL-DMA (50% in 9 weeks). In vivo pharmacokinetic studies of fluticasone-loaded rings were carried out in a pig model. A new LC-MS/MS method was successfully developed to quantify fluticasone in pig plasma (LLOQ 10 pg/mL) and esophageal tissue (LLOQ 100 pg/g).<br/>Conclusions: We have developed an innovative technology for EoE, which is in need of new treatment options and drug delivery systems. This foundational work can serve as a platform for the treatment of other esophageal diseases including esophageal cancer.

Development of a novel 3D printed, drug-eluting, biodegradable ring for treatment of eosinophilic esophagitis

2019 Spring National Meeting

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