Our objective was to develop a bioadhesive vaginal tablet formulation of ornidazole by using different polymer mixtures, to evaluate the bioadhesive tablet properties, and to investigate the irritation potential of the formulations to the rat vaginal tissue. Vaginal tablets of ornidazole were directly compressed with bioadhesive and swellable polymer mixtures as release-controlled agents. Carbopol 934 (Cp), pectin (Pc), hydroxypropylmethylcellulose (HPMC), sodium carboxymethylcellulose (Na CMC), and guar gum (GG) were used in different ratios. Bioadhesive properties, swelling capacity, release studies, and histological studies of the formulations were carried out. The bioadhesive strength between bovine vagina and surface of the tablets was determined by tensile experiments, and it was found to be dependent on Cp content. The release mechanism was described and found to be non-Fickian for all formulations. Dissolution data were evaluated statistically. No histological damage was found except one formulation containing high amount of guar gum.
A new and alternative evaluation method is preferred for swelling studies of bioadhesive tablet formulations. CIELAB color coordinates, related to visual color response, are used for the first time to follow the swelling state and to calculate the swelling volume. The results are evaluated statistically. A simple equation is given to explain the relation between the swelling volume change % and color difference for three different bioadhesive formulations. It was found that the estimated equation is in good agreement with observed swelling volume results.
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