{Reference Type}: Journal Article
{Title}: Mucoadhesive Budesonide Solution for the Treatment of Pediatric Eosinophilic Esophagitis.
{Author}: Spennacchio A;Lopalco A;Racaniello GF;Cutrignelli A;la Forgia FM;Fontana S;Cristofori F;Francavilla R;Lopedota AA;Denora N;
{Journal}: Pharmaceuticals (Basel)
{Volume}: 17
{Issue}: 5
{Year}: 2024 Apr 24
{Factor}: 5.215
{DOI}: 10.3390/ph17050550
{Abstract}: Eosinophilic Esophagitis is an antigen-mediated inflammatory disease characterized by thickening of the esophageal wall, leading to dysphagia, vomiting, reflux, and abdominal pain. This disease can be treated with a therapeutic approach ranging from diet to pharmacological therapy. Jorveza® (budesonide) and Dupixent® (dupilumab) are treatments for Eosinophilic Esophagitis approved by the European Medicines Agency in adults but not in children. Budesonide-based extemporaneous oral liquid suspensions could be prepared for pediatric use. The main limit of this formulation is that budesonide needs a longer residence time on the esophageal mucosa to solubilize and diffuse in it to exert its local anti-inflammatory effect. Herein, we propose the development of an extemporaneous mucoadhesive oral budesonide solution for the pediatric population. A liquid vehicle containing hydroxypropyl-beta-cyclodextrin as a complexing agent and carboxymethylcellulose sodium as a mucoadhesive excipient was used to prepare budesonide-based formulations. A stable solution at a concentration of 0.7 mg/mL was successfully prepared and characterized. The formulation showed rheological and mucoadhesive properties suitable for an Eosinophilic Esophagitis local prolonged treatment. In this way, pharmacists can prepare stable budesonide-based mucoadhesive solutions, providing both patients and physicians with a new therapeutic option for Eosinophilic Esophagitis pediatric treatment.