OPTIMIZATION OF QUERCETIN LOADED FAST DISSOLVING FILMS BY EMPLOYING QBD AS A DESIGNING TOOL FOR IMPROVED BIOAVAILABILITY

Quercetin was found to be BCS class-4 molecule with desired cancer preventive activity but characterized by lower solubility and permeability. To overcome the issues associated with Quercetin, the current research was designed for the development of cyclodextrin based inclusion complexes loaded orally fast dissolving films (ICQF). For the preparation of ICQFs, the film former, plasticizer and the super disintegrant was selected as methyl cellulose, PEG 400, either croscarmellose sodium/ starch citrate respectively. To develop the formulation with desired properties, box behnken design of quality by design (QbD) was employed and the same was analyzed to find the optimized combination of different variables. The ICQFs were evaluated for their physical characterization, drug content and disintegration time of the ICQFs were observed to be in the range of 0.13-0.27 mm, 447-663, 6.6-10.4 MPa, 20.4-30.7%, 96.3-102.4% and 32-312 sec. respectively. Along with the physico chemical characterization, the ICQFs were evaluated for its dissolution and pharmacokinetic behavior. The effect of different factors were studies on the desired responses like disintegration time and dissolution after 10 minutes (D10). From the graphical optimization, a fresh formulation was prepared with 500 mg of film former, 1.16% v/v of plasticizer and 7.5% of super disintegrant. The DT and D10 for the optimized formulation was found to be 32.9 sec. and 82.4% respectively. Along with the in-vitro performance, the in-vivo behavior was also evaluated by performing the pharmacokinetic study using male Sprague–Dawley (SD) rats and the bioavailability of the formulation found to be improved in comparison to the plain drug suspension. The investigation was found to be innovative with successful attainment of the hypothesis.