Formulation and evaluation of mouth dissolving film loaded with solid dispersion of azithromycin

Abstract

The main objective of the present work was to formulate mouth dissolving films containing azithromycin solid dispersion to attain its maximum drug release with a very short time and also to have an easy and compliant administration of the drug through oral route. The solid dispersion prepared using β-cyclodextrin was obtained in yield of approximately 96% suggesting completion recovery of the dissolved material. Pure azithromycin was found to exhibit a solubility of 36.2 µg/mL after 24 hours whereas the solid dispersion exhibited a significant increase in solubility showing a solubility of 267 µg/mL. Mouth dissolving films were prepared using xanthan gum and exhibited quick drug release, rapid disintegration and optimal mechanical strength. The amount of drug loaded in the films was independent of the polymer concentration though it was found that level 0 of the variable X₁, the drug uptake by the polymeric matrix was slightly lower. All the formulations had drug content of more than 90% with the highest content in formulation F4 (97.1 ± 4.42%) and the lowest in F2 (93.4 ± 2.31%). The formulations were also found to be able to release almost complete drug content within a period of 10 minutes. The maximum amount of drug was released by F4 (92%) while F5 released the lowest amount of drug (85%) in the same period.