Development and evaluation of buccal films impregnated with selegiline-loaded nanospheres.

Poor peroral therapeutic efficiency of selegiline is primarily due to the extensive hepatic metabolism and hence the need for an alternative route of administration. The present study is based on evaluation of a buccal film which is impregnated with selegiline nanospheres to enhance the systemic bioavailability. Selegiline-loaded nanospheres prepared using poly(lactide-co-glycolide) was embedded into buccal films (F1-F4) with varying polymer composition [hydroxypropyl methylcellulose and eudragit]. The developed films were evaluated for their physicomechanical properties, hydration, mucoadhesive strength, in vitro drug release and ex vivo permeation in order to identify the ideal system suitable for further development. In vivo studies were carried out on rabbits to assess the comparative pharmacokinetics profile of the selected buccal film with oral solution. Preliminary studies indicated that the prepared films exhibited excellent physical properties, adequate mucoadhesive strength and moderate hydration. In vitro drug release data of the buccal films (F1, F2 and F3) showed distinct profiles. Permeation studies indicated higher steady-state flux from film F3 (p < 0.0001) when compared to film F2. In-vivo results of film (F3) demonstrated significant increase in absorption (p < 0.0001), Cmax (∼1.6-fold), Tmax, AUC0-α (∼3-fold, p < 0.0001) and improved bioavailability, when compared to control. This study concludes that the buccal delivery of selegiline using the developed buccal film (F3) would be a promising alternative approach for the treatment of Parkinson's disease.