Studies on Design and Development of Mouth Dissolving Film of Desloratadine

ABSTRACTIn the present study, formulation of mouth dissolving film containing antihistaminic drug Desloratadine was designed to achieve immediate release of drug from the dosage form, to increase therapeutic efficacy and to improve patient compliance in case of allergy. The combination of drug with suitable polymers such as HPMC E-5 and HPMC E-15 helps in providing quick release of the drug. Mouth dissolving film was prepared by solvent casting method using PEG 400 as plasticizer. A 32 full factorial design was applied to an optimized the effect of independent variables like HPMC E-5 and HPMC E-15 on dependent variables like disintegration time, thickness and folding endurance of the film. The responses were analyzed using design of expert software and it was found that the concentration of HPMC E-5 and HPMC E-15 significantly affects on dependent parameters. The prepared optimized formulation showed minimum disintegration time (10s) and highest dissolution rate (99.02 ± 0.284 %). The two check point formulations were prepared as suggested by the software. All the predicted values of responses were found to be close to the observed values. Stability study shows that there was no significant change in physical appearance, disintegration time, thickness, drug content and In vitro drug release of the formulation. Mouth dissolving film is an innovative concept for quick release of the drug. Thus, allergy can be quickly treated by this formulation. Keywords: Mouth Dissolving film, Desloratadine, HPMC E-5, HPMC E-15, Test masking