Objective: To develop and characterize a new form of vaginal film.Significance: This formulation is intended to overcome some known limitations of traditional dosage forms. It has an absorptive intention to control symptoms and to improve the treatment of vaginal infections characterized by excessive fluid. The vaginal sheet is a thick drug delivery system easy to manipulate, nontoxic and composed by biocompatible macromolecules and polymers, such as gelatin and chitosan.Methods: The sheets were prepared by formulating gelatin or chitosan based gels isolated or in combination, in association with a plasticizer. Gels were subsequently lyophilized. Different proportions of polymer:plasticizer were tested. Lactose was used as a surrogate to study powder incorporation in the formulation. All formulations were analyzed regarding their organoleptic characteristics, texture (hardness and resilience), in vitro absorption efficiency of vaginal fluid simulant - VFS (pH 4 and 5), pH and acid-buffering capacity.Results: Different properties were obtained by varying polymer and plasticizer proportions. Combinations including gelatin with propylene glycol showed the best organoleptic characteristics. The best proportions were 4:3 and 4:5. Up to 10% of powder was successfully incorporated in the formulation. Hardness and resilience of formulations were largely dependent on the concentration of plasticizer. Absorption of vaginal fluid was found to be highly efficient, especially at pH 5. Buffering capacity, upon dilution in normal saline and VFS, was generally higher for VFS pH 4.Conclusions: The vaginal sheet is a promising solid drug delivery system able to further incorporate drugs to treat vaginal clinical conditions characterized by excessive fluid.
Keywords: Vagina; dosage form; vaginal infections; vaginal sheet.