title: Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: Faculdade de Farmácia, Departamento de Medicamentos-UFRJ, Brazil..
authors: Michelle Maria Gonçalves Barão
authors: MM
authors: de Aguiar
authors: Raphael Pereira
authors: RP
authors: de Albuquerque
authors: Daniel Savignon
authors: DS
authors: Marinho
authors: Bárbara Regina Souza
authors: BR
authors: Braga
authors: Camila Braga
authors: CB
authors: Dornelas
authors: Anderson
authors: A
authors: Oliveira
authors: Valéria Pereira
authors: VP
authors: de Sousa
authors: Sandra Regina
authors: SR
authors: Torres
authors: Daniela Sales
authors: DS
authors: Alviano
authors: Celuta Sales
authors: CS
authors: Alviano
authors: Lúcio Mendes
authors: LM
authors: Cabral
authors: Carla
authors: C
authors: Holandino
mesh_terms: D000284:Administration, Oral; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000378:metabolism; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects / Q000378:metabolism; D009761:Nystatin / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D010865:Pilot Projects; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D013607:Tablets; D009761:Nystatin