Design and development of a mucoadhesive buccal film bearing progesterone.

The purpose of this research was to develop and evaluate mucoadhesive films for buccal administration of progesterone using film-forming and mucoadhesive polymers. Buccal films of chitosan bearing progesterone were prepared by solvent casting technique. The films have been evaluated in terms of film weight, thickness, density, surface pH, FT-IR, X-ray diffraction analysis, bioadhesion, swelling properties, in vitro drug release and in vivo studies. It was found that the film formulations of 2 cm2 size having weight in the range of 239 +/- 0.32 to 290 +/- 3.23 mg and film thickness were in the range of 0.49 +/- 0.21 to 0.60 +/- 0.26 mm. Density of the films was found to be 0.108 to 0.139 g/mL. Drug content was found to be uniform in a range of 9.21 +/- 0.051 to 9.67 +/- 0.086 mg/cm2 for formulation F1 to F4. Maximum bioadhesion force was recorded for PVP buccal films (formulation F2) i.e. 0.45 +/- 0.53 N as compared to other films. In vitro residence time was in range of 1.85 +/- 0.08 to 8.94 +/- 0.08 h. The drug release studies revealed that formulations follows non-fickian diffusion. In vivo residence time data confirmed that none of the polymers detached from the oral mucosa over the study period, which indicated that the bioadhesion values of all polymers were satisfactory to retain the film on the buccal mucosa. These mucoadhesive formulations could offer many advantages in comparison to traditional treatments and their efficacy as an effective contraception is assessed.