Abstract

The aim of the presented research was the preparation and in vitro and in vivo evaluation of mucoadhesive oral films containing nystatin. Multivariate data analysis was used to evaluate an innovative approach, in which a combination of different mucoadhesive polymers was employed. The purpose of this was to assess the effects of such a combination on non-woven insoluble carmellose textile as a drug-release modifier in the structure of the film.

It was observed that the mucoadhesive films prepared using polyethylene oxide were more plastic, showed less mechanical resistance and shorter in vitro residence time in comparison with films containing sodium carmellose. The textile used in films containing sodium carmellose significantly prolonged both in vitro and in vivo residence times in rabbits from 50 ± 4 min until 74 ± 4 min and from 48 ± 6 until 80 ± 4 min, respectively. A higher degree of substitution by the acid carboxymethyl group of the textile resulted in slower nystatin dissolution, longer in vitro and in vivo residence times, and higher tensile strength. Textural parameters tensile strength and tensile deformation in conjunction with linear discriminant analysis were able to distinguish the degree of substitution of the textile due to its impact on the studied parameters.

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