Delivery of itraconazole from extruded HPC films

The treatment of onychomycosis by oral delivery is problematic due to the high concentrations required and if available, a topical transcuticular route would be preferred. Towards this end the hot-melt extruded hydroxypropylcellulose based films containing anti-fungal drug itraconazole and alpha-tocopherol topical treatment for onychomycosis were studied. DSC and X-ray measurements did not show a crystalline itraconazole phase indicating the drug is present in the amorphous state. The rate of itraconazole release trended directly with the degree of film hydration and inversely to the hydroxypropylcellulose molecular weight. This results from a higher degree of crystallinity of the HPC films which also changes the release kinetics from first order to zero order as a more tortuous path is created.