Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination.
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.
de Aguiar
Michelle Maria Gonçalves Barão
MM
Faculdade de Farmácia, Departamento de Medicamentos-UFRJ, Brazil..
de Albuquerque
Raphael Pereira
RP
Marinho
Daniel Savignon
DS
Braga
Bárbara Regina Souza
BR
Dornelas
Camila Braga
CB
Oliveira
Anderson
A
de Sousa
Valéria Pereira
VP
Torres
Sandra Regina
SR
Alviano
Daniela Sales
DS
Alviano
Celuta Sales
CS
Cabral
Lúcio Mendes
LM
Holandino
Carla
C
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
D003692:Delayed-Action Preparations; D013607:Tablets; D009761:Nystatin