ACTA Pharmaceutica Sciencia 2010 , Vol 52 , Num 4
DISSOLUTION AND HISTOLOGICAL STUDIES ON ORNIDAZOLE VAGINAL FORMULATIONS
S YAPRAK KARAVANA, E HOMAN GÖKÇE, M ÖZYAZİCİ, E BALOĞLU, H SAĞLAM, Ç PEKÇETİN, D ÖZYURT, G ERTAN, T GÜNERİ
Department of Pharmaceutical Technology, Faculty of Pharmacy, Ege University, 35100, Bornova, İzmir, Turkey. In this study our objective was to develop suitable vaginal formulations of ornidazole, to evaluate the physicochemical properties, to investigate the irritation potential of the formulations to the rat vaginal tissue and compare these formulations with commercially available vaginal formulation. Vaginal and effervescent vaginal tablets of ornidazole were prepared by wet granulation technique. Vaginal and effervescent vaginal suppositories were prepared by fusion method. The drug amount of the formulations was determined by a validated method using an HPLC with two different media (phosphate buffer and artificial vaginal fluid solutions). In vitro dissolution test, kinetical analysis of data and histopathological studies of the formulations were carried out. According to the dissolution studies, vaginal effervescent suppository formulation shows the fastest release with a similarity to commercially available vaginal tablet. The release mechanism was described and found to be non-Fickian for all formulations. Dissolution data were evaluated statistically. No histological damage was found for all formulations. Keywords : ORNIDAZOLE, VULVO-VAGINAL CANDIDIASIS, VAGINAL SUPPOSITORY, VAGINAL TABLETS, EFFERVESCENT VAGINAL FORMULATIONS

Istanbul Medipol University