Hard lozenge based on miconazole nitrate intended for oral use

Abstract

The present invention relates to the development of a hard lozenge containing miconazole nitrate, intended for oral use in the treatment of fungal mycoses, as a replacement for an existing gel. This new formulation allows for prolonged contact of the active ingredient with the mucous membrane, thus improving therapeutic efficacy. The addition of flavoring to the formula and the presence of sucrose further improve the taste and therefore treatment adherence. The lozenge offers increased microbiological stability, simplified administration, and improved adhesion to the oral mucosa. Rigorous quality controls, including dosage, pharmacotechnical, microbiological, and antifungal activity tests, have confirmed the product's compliance with current pharmaceutical standards.