Design and Characterization of Fast Dissolving Films of Cilnidipine Solid Dispersions

The major problem in formulation of oral films of cilnidipine is that it belongs to BCS Class II moiety. Pharmacologically Cilnidipine is a dihydropyridine (DHP) type of calcium channel antagonist. Unlike other calcium channel antagonists, Cilnidipine blocks the influx of Ca2+ ions into both vascular smooth muscle at the level of L-type Ca2+ channels and neuronal cells at the level of N-type Ca2+ channels. Cilnidipine was absorbed over 2 hours and its bioavailability is 64-90%. Hence there is a need to increase the solubility and oral bioavailability of cilnidipine by formulating it in to solid dispersions and incorporating the same in to the formulation of fast dissolving films which gives fast onset of action. Nine formulations (FC 1 - FC 9) of cilnidipine films were prepared and evaluated for their physical characteristics such as thickness, weight variation, folding endurance, drug content uniformity and gave satisfactory results. The compatibility of the drug in the formulation was confirmed by FTIR and DSC studies. The formulations were subjected to disintegration, in vitro drug release studies and formulation FC 6 was found to be best formulation which contain HPMC, PVP as film forming polymers along with cilnidipine solid dispersion with poly ethylene glycol at weight ratio of 1:4 showed excellent film forming characteristics such as disintegration time of 49.3 sec and percentage drug release 97.92 within 8 minutes.