Formulation and evaluation of medicated lozenges containing the solid dispersion of Clotrimazole /PEG 6000 for the treatment of oral candidiasis

The study aimed to formulate Clotrimazole (CLM) as solid dispersion medicated lozenges with enhanced dissolution for treating oropharyngeal candidiasis. They are suitable for many patients and easy to administer. The study used the solvent evaporation method to prepare solid dispersions of CLM using polyethylene glycol 6000 and polyvinyl pyrrolidone at different drug-to-carrier weight ratios. The study found that PEG 6000, when used at a 1:1 weight ratio, significantly improved the dissolution of CLM. The results of the FTIR studies showed that the drug was dispersed within PEG 6000, and there was no drug interaction with the excipients used in medicated lozenge formulations. A 32-factorial design was used to develop, optimize, and evaluate nine formulations of the solid dispersion of CLM/PEG 6000 medicated lozenges for improved therapeutic outcomes. We fabricated the lozenges using biocompatible polymeric gelling agents (chitosan, methyl cellulose, and sodium alginate) at three different levels (0.5, 1, and 1.5%). All the medicated lozenges were uniform in weight and drug content within USP limits, with complete drug release rates ranging from 10–20 minutes for chitosan and sodium alginate formulations, compared to 60 minutes for methyl cellulose. The results showed that the type of polymer and its concentration significantly impacted drug release. The optimized formulation, F-3, containing 1.5% CH, exhibited a drug release of 100.83% ±0.68 at the end of 10 minutes. It demonstrated significant antifungal activity against Candida albicans (p < 0.05), making it suitable for drug delivery in the oral cavity.