Novel ex vivo protocol using porcine vagina to assess drug permeation from mucoadhesive and colloidal pharmaceutical systems.

Local treatment of vaginal diseases presents advantages over systemic treatments and the interaction of the drug delivery systems with the biological tissue is a key factor for a successful vaginal topical therapy. Conventional protocols for permeation studies have high variability and fail in distinguishing drug penetration from mucoadhesive or colloidal drug delivery systems from conventional formulations, as tissue interaction is normally under estimated. The protocol presented in this paper is a simplified ex vivo vertical model, in which formulations are placed in hung porcine vaginas with the objective of mimicking a condition closer to the biological circumstance, specifically considering the possible leak from the vaginal canal in the vertical position. The results indicate the proposed method was capable of differentiating formulations performances and histological evaluation showed mucosa structures are preserved during this new assay. Therefore, the ex vivo method can be considered reliable for approaching the physiological situation in comparative studies.