Performance evaluation of Risperidone loaded bio-flexi films using Cucurbita pepo.
Research design and Methods:
The risperidone loaded bio-flexi films was prepared using novel bio-film former isolated from fruit pulp of Cucurbita pepo by solvent casting method with different ratios (1%, 2%, 3%, 4%, 5% and 8%) and with standard polymer HPMC and CMC-Na (1%, 2%, 3%, 4% and 5%). The prepared formulations were evaluated for thickness, folding endurance, swelling index, content uniformity, in-vitro drug release, scanning electron microscopy (SEM), transmission electron microscopy (TEM), invitro cytotoxicity and stability studies.
The best formulation shows an R2 value of 0.9814, T50% of 29.7 hrs and T80% of 65.25 hrs respectively. According to the release kinetics the best fit model was found to be Peppas Korsmeyer with Fickian Diffusion (Higuchi Matrix) as the mechanism of drug release. Cucurbita pepo provided excellent filmability and stability having particle size of 252 nm and zeta potential of -8.91 mV. Distribution of drug in the film was studied by using SEM. TEM confirms the spherical shape of nanoparticle having range of 20 nm. Histology study shows there is no evidence of inflammation or necrosis.
Cucurbita pepo act as a film former in risperidone loaded rate controlled bio-flexi film.