Efficacy and safety assessment of PIMIN050 raft-forming system as medical device based on Citrus sinensis and Crassostrea gigas for the management of gastroesophageal reflux disease

Abstract

The present study wants to explore the use of Citrus sinensis hydrolyzed powder and Crassostrea gigas shell powder as main components for the development of an effective and safe medical device, called PIMIN050, acting as raft-forming anti-reflux agent in gastroesophageal reflux disease (GERD) management. The developed raft system was characterized by its strength, resilience, neutralization profile, floating lag time and total floating time and showed a significant mucoadhesive and film-forming behaviour and the ability to completely inhibit pepsin diffusion in vitro. In addition, a relevant barrier effect and protective role was observed in an ex vivo swine model of damaged esophageal mucosa. Finally, safety studies confirmed the biocompatibility of the developed formulation, which resulted not cytotoxic and did not show any pro-sensitizing potential and irritant effect on in vitro oral mucosa. Therefore, these findings support the use of Citrus sinensis hydrolyzed powder and Crassostrea gigas shell powder as renewable raw materials with high added value for pharmaceutical industry and, in particular, in the development of an effective and safe product for GERD treatment.