Formulation studies of benzydamine mucoadhesive formulations for vaginal administration

The aim of this work was the design of semisolid mucoadhesive formulations for benzydamine vaginal application. These preparations were obtained by using carboxymethylcellulose sodium salt (NaCMC) and hydroxyethylcellulose (HEC). Simple gels were prepared and were employed to prepare the water phase of O/W cream (cetomacrogol based cream) to obtain the emulgels. Successively, in order to modify the emulgel consistency, the ingredient cetostearylic alcohol was replaced by the same amount of gel or vaseline. These preparations were submitted to mucoadhesion, rheological, extrusion and release studies and were compared to market vaginal cream Tantum Rosa®. Formulations containing HEC showed good drug release profiles and good rheological behaviour but low mucoadhesion strength, while those prepared by NaCMC (4% gel) had better drug release and very high mucoadhesive values. However, the presence of NaCMC 4% inferred too much viscosity to the preparation. Taking into consideration all performances, the formulations more suitable for vaginal applications were those containing NaCMC (3% gel) and where the gel replaced cetostearylic alcohol. In fact these preparations showed good performances in term of usability, patient compliance and higher bioadhesion to vaginal mucosa than the cream from the market