Development of Mucoadhesive Vaginal Films for Metronidazole Delivery Using Methacryloylated, Crotonoylated, and Itaconoylated Gelatin Blends with Poly(vinyl alcohol)

Purpose This work reports the development and characterisation of polymeric films composed of gelatin or its chemically modified derivatives (crotonoylated, itaconoylated, and methacryloylated gelatins) blended with polyvinyl alcohol (PVA). Metronidazole served as an antimicrobial drug in these formulations. Methods The films were produced by casting aqueous solutions of polymers, followed by solvent evaporation. Their structure and physicochemical characteristics were studied using Fourier transform infrared spectroscopy, scanning electron microscopy, and mechanical testing. The thickness of the films, their folding endurance, the surface pH, and transparency were also evaluated. The mucoadhesive performance of the films was evaluated through an ex vivo detachment technique involving freshly excised sheep vaginal tissues. In vitro cumulative drug release studies were conducted using Franz diffusion cells. Results The results demonstrate that incorporating unsaturated functional groups into gelatin improves its mucoadhesive properties compared to native gelatin. The drug release experiments conducted in vitro showed that the cumulative release from pure gelatin/PVA films was found to be 49 +/- 2%, whereas modified gelatins/PVA (70:30) films released similar to 64-71%. Conclusion These findings suggest that modified gelatins could serve as effective excipients in designing mucoadhesive formulations for vaginal administration, with potential applications extending to other transmucosal drug delivery systems.