Eosinophilic esophagitis (EE) is a chronic immune/antigen-mediated esophageal\ninflammatory disease for which off-label topical corticosteroids (e.g., budesonide) are widely used in\nclinic. In general, thickening excipients are mixed with industrial products to improve the residence\ntime of the drug on the esophageal mucosa. The compounding procedures are empirical and the\ncomposition is not supported by real physicochemical and technological characterization. The\ncurrent study aimed to propose a standardized budesonide oral formulation intended to improve\nthe resistance time of the drug on the esophageal mucosa for EE treatment. Different placebo\nand drug-loaded (0.025% w/w) formulations were prepared by changing the percentage of xanthan\ngum alone or in ratio 1:1 with guar gum. Both excipients were added in the composition for their\nmucoadhesive properties. The formulative space was rationalized based on the drug physicochemical\nstability and the main critical quality attributes of the formulation, e.g., rheological properties,\nsyringeability, mucoadhesiveness and in vitro penetration of budesonide in porcine esophageal\ntissue. The obtained results demonstrated that gums allowed a prolonged residence time. However,\nthe concentration of the mucoadhesive polymer has to be rationalized appropriately to permit the\nsyringeability of the formulation and, therefore, easy dosing by the patient/caregiver.
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