J. Ravi Kumar Reddy*, P Neelaphar, Chakka Gopinath
Department of Pharmaceutics, Annamacharya College of Pharmacy, Rajampeta–516126, Kadapa, Andhra Pradesh, India
A B S T R A C T
In this study the attempt was made for preparation of buccoadhesive films of Diclofenac sodium by using bioadhesive polymers like sodium alginate and PVP K-30 which will improve oral bioavailability by sparing the drug from first pass metabolism and reduce the dosing frequency. Drug: HPβ-CD complex was incorporated in the buccoadhesive film to improve the dissolution of poorly water soluble drug from the polymeric film. The Preformulation study was carried out using raw materials. Buccoadhesive films were formulated by using solvent casting method. Films were prepared by varying the percentage of sodium alginate and PVP K-30. All prepared films were evaluated for physical characterization, in vitro swelling, in vitro bioadhesion, in vitro drug release, in vitro drug permeation. From the prepared film F3 was selected as it showed appropriate swelling, duration of bioadhesion, drug release and permeation. Results indicated that the release rate from film F3 best fitted Korsemeyer and Peppas (R2=0.9996), followed by zero order (R2=0.9963) and then square root t kinetics (0.9075). The value on n =1.1655 indicated that release from film followed Super Case II transport. The optimized film was subjected to stability study and histopathological examination on porcine buccal mucosa. Also the film was stable in human saliva, no color change was observed. Histo-pathological studies revealed no effect on the mucosal histology after application of film for 10 hrs. The optimized formulation showed better stability under accelerated stability conditions for three months.
Keywords: Buccoadhesive films, Bioadhesion, Bioavailability, Diclofenac, HPβ-CD complex.