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Pharmacological evaluation of oral fast disintegrating films containing local anaesthetic agent lignocaine

Heng-zhong Xu, Jing Li, Xiao-xiu Fu

The aim of the present research was formulate and develop Lignocaine containing oral fast disintegrating films to treat mouth ulcers as well as to evaluate the local anaesthetic activity of the formulation using tail flick test in rat model. 3² full factorial design was used to formulate oral fast disintegrating films by solvent casting evaporation technique. Chitosan, Croscarmellose Sodium (CCS) and Dibutyl Phthalate (DBT) were used as polymer, superdisintegrant and plasticizer respectively. Chitosan, CCS and DBT were considered as independent variables while disintegration time and in vitro drug release were considered as dependent variables. Effect of independent variables on dependent variables was studied using design expert software. In vitro drug release, disintegration time, physical appearance, folding endurance, physical appearance, thickness, weight variation, drug content uniformity of the films were characterized. The local anaesthetic efficacy of the films was evaluated on healthy male rats by tail flick test. The optimized film showed disintegration within 10 sec and 98.85% drug release over the period of 1 h. All independent variables selected for the study were statistically significant (p<0.05). The local anaesthetic efficacy of films with CCS was found to be highest (2932.87 ± 78.30 AUEC (sec/min)) as compare to control film and films without CCS (p<0.05). The films complies the requirements for oral drug delivery. The study concludes that oral fast disintegrating films of Lignocaine serves as potential drug delivery systems for mouth ulcer management.