Preparation and Characterization of Orodispersible Films Loaded Diclofenac Sodium/β-Cyclodextrin Inclusion Complexes

Abstract

Orodispersible films (ODFs) is orally pharmaceutical dosage form that rapidly disintegrates and instantly releases the drug when placed on the tongue. This study was firstly aimed to investigate physicomechanical properties of ODFs containing diclofenac sodium/β-cyclodextrin (DS/βCD) inclusion complexes prepared by solvent casting method. The influence of plasticizer, βCD and DS on hydroxypropyl metlhycellulose (HPMC) film was studied. Increasing of plasticizer concentration (e.g. PEG400 amd glycerol) resulted in decrement of disintegration time, strength and elasticity of HPMC films. When βCD was incorporated, opaque films were observed. Presence of βCD resulted in degrading of physicomechanical properties, except percentage of elongation representing the film’s elasticity. βCD films containing DS (DS/βCD films) were more brittle and transparent than blank βCD films. Amount of incorporated DS influenced on disintegration time and strength of obtained films. Cross-section scanning electron microscope (SEM) photomicrographs showed spherical particles scattered on DS/βCD films illustrating the occurrence of DS/βCD inclusion complexes during casting process. The DS/βCD inclusion complexes were then confirmed in both solid and solution. Furthermore, DS/βCD ODFs were prepared by incorporation of artificial sweeteners in DS/βCD films. It was found that DS/βCD ODFs containing xylitol were more brittle and their disintegration times were faster then those containing sucralose. Dissolution profiles were investigated then reported that release kinetic of DS/βCD films and ODFs were fitted to Higuchi model. In summary, the βCD-based ODFs containing DS were successfully developed.