Fast Dissolving Oral Film of Piroxicam: Solubility Enhancement by forming an Inclusion Complex with β-cyclodextrin, Formulation and Evaluation

Objective: Piroxicam is a long-acting potent nonsteroidal anti-inflammatory drug (NSAID) which has a very low solubility in Gastrointestinal (GI) fluids results in poor bioavailability after oral administration. The present investigation aimed to formulate and evaluate fast dissolving oral films containing piroxicam to overcome solubility and bioavailability problems thereby to facilitate the convenience of pediatric and geriatric patients. Method: The inclusion complexes of piroxicam with beta-cyclodextrin were prepared. In vitro dissolution study was performed to fix the ratio with better dissolution rate. The selected inclusion complex was then utilized for the preparation of fast dissolving oral films by solvent casting method using sodium CMC/chitosan as film-forming agents, sodium starch glycolate/crospovidone as super disintegrating agents. PEG 400 used as a plasticizer. Formulations (F1-F12) were prepared and evaluated for their physicochemical properties. In vitro disintegration, dissolution and permeation studies were also carried out. Results: Formulation F2 showed the minimum in vitro disintegration time (14.94 +/- 3.06 s), formulation F9 showed the maximum in vitro disintegration time (36.66 +/- 1.05 s). The formulations F6 and F4 showed better drug release of 94.4% and 92.9% respectively. Better drug permeation of 96.65% was obtained from the formulation F6 in 40 s. Conclusion: The study concluded that the fast dissolving films achieved quicker onset of action compared to the conventional preparations. The formulation found promising to obtain better therapeutic efficiency.