Abstract
Formulation And Evaluation Of Buccal Films Of Salbutamol Sulphate
Buccal films of salbutamol sulphate were prepared using three different polymers in various proportions and combinations. The physicochemical parameters like thickness, density, folding endurance, swelling index, mucoadhesive strength based on shear stress and tensile strength, water permeability, drug content and drug release characteristics were evaluated in order to study the effect of polymer and its concentration on the drug release. The properties of the drug free buccal films were compared with the films obtained after drug incorporation in order to study the effect of drug loading on the film characteristics. The thickness and density of all the films produced were in the range of 0.15 to 0.24 mm and 1 .104 to 1.445 g/cm3, respectively. High folding endurance was observed for films containing ethyl cellulose and its combination with hydroxypropylmethyl cellulose. The swelling index was found to be high for formulation F2 containing Eudragit RL100, 6% w/v and 3.2 g of glycerol 40% w/w. The results of the mucoadhesive strength measurement based on shear stress indicated that the buccal films of formulation F4 containing each 3% of hydroxypropylmethyl cellulose and ethyl cellulose exhibited a high value, but the tensile strength measurement studies indicated high mucoadhesive strength for formulation F2, Water permeability was found to be high for formulation F1 containing 6% w/v of Eudragit RL 100 and 2.4 g of glycerol 40% w/w. Drug content uniformity was observed for all films. The drug release studies indicated the first order controlled release kinetics in all cases and the release was extended up to 8 h for formulation F4. It was also observed that the lower the permeability coefficient the greater was the extended release characteristics for the buccal films. Finally it was concluded that the polymers and their combination influenced the film properties as well as release characteristics.