Nanocomposite suppository intended for topical vaginal delivery of clotrimazole

The high prevalence of vulvovaginal candidiasis necessitates the development of better treatments. This study aimed to develop a novel nanocomposite vaginal suppository incorporating gelatin and clotrimazole-loaded coconut oil nanocapsules. The nanocapsule suspensions, prepared using Eudragit® RS100, achieved a size of under 190 nm, a polydispersity index of below 0.15, nearly 100% drug content and encapsulation efficiency, a positive zeta potential of +8.5 mV, and an acidic pH. The mucoadhesive properties were confirmed through mucin interaction tests. Suppositories were formulated by integrating gelatin and glycerin into the nanocapsule suspension, maintaining the nanometric size at 135 nm and attaining a high drug content of 97.48%. The nanocomposite suppository demonstrated an enhanced control of drug release, with 40% released in 5 hours, in contrast to 80% from the non-nanotechnological formulation. Additionally, drug retention in cow vaginal mucosa was superior with the nanocomposite suppository (11.95 μg/cm2) compared to the non-nanotechnological formulation (8.18 μg/cm2). The dispersion time did not exceed 60 minutes (24.29 ± 1.91 minutes). The washability test confirmed high mucosal retention, evidenced by drug concentrations in the lavage fluid being lower than 5% for both formulations (nanocomposite and control). These results suggest the feasibility of a nanocomposite suppository with desirable characteristics for vaginal drug delivery, representing a promising alternative for the management of vulvovaginal candidiasis.