Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination.
Author(s): de Aguiar MM, de Albuquerque RP, Marinho DS, Braga BR, Dornelas CB, Oliveira A, de Sousa VP, Torres SR, Alviano DS, Alviano CS, Cabral LM, Holandino C
Affiliation(s): Faculdade de Farmacia, Departamento de Medicamentos-UFRJ, Brazil..
Publication date & source: 2010-05, Drug Dev Ind Pharm., 36(5):594-600.
Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Validation Studies
OBJECTIVE: In this study, oral sustained release mucoadhesive nystatin tablets were developed to increase nystatin contact time with the oral cavity and mask its unpleasant taste. METHODS: The best formulation studied included sustained release agents and it was submitted to physical-mechanical characterization, taste assessment and clinical test in twelve patients. The ultraviolet-visible nystatin methodology was also developed and validated in parallel as an alternative to the pharmacopoeial microbiological dosage method. RESULTS: The best formulation developed in this study included sustained release agents. The efficacy of this formulation was verified through a clinical assessment, showing that this formulation is more effective (100%) than the commercial oral nystatin suspension used traditionally (50%). Moreover, the UV absorption spectrophotometry method developed to validate the methodology for nystatin content analysis for new oral tablets was shown to be specific, linear, exact and reproducible, as recommended by the ICH regulations. CONCLUSION: The oral nystatin tablets developed showed to present faster therapeutic response than the oral aqueous solution through the preliminary clinical assays. The UV absorption spectrophotometry method showed to be an attractive test for the usual routine in the pharmaceutical industry.