Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for clindamycin phosphate

Abstract

To develop more effective treatment for bacterial vaginosis, bioadhesive film formulations of clindamycin phosphate (CL) for vaginal delivery were studied. The bioadhesive films were prepared by solvent evaporation method. A 3² full factorial design was utilized for optimization of the effect of independent variables such as amount of hydroxypropyl cellulose (X1), amount of xanthan gum (X2) on mechanical properties, and % drug retained on vaginal mucosa. The films were evaluated for various aesthetic and physicodynamic properties. Batch F₈₆ showed highest overall desirability of 0.99. Batch F86 was considered optimal composition for a novel bioadheive vaginal formulation, as they have good peelability, high % elongation at break, moderate tensile strength, and retained on vaginal mucosa up to 8 h. Also, films were non-cytotoxic as indicated by negligible decrease in cell viability. Our study may provide a potential vaginal delivery system of CL against bacterial vaginosis.

Keywords::

• Clindamycin phosphate
• bioadhesive vaginal film
• factorial design
• desirability function
• bioadhesion