Preliminary Study on the Development of Orodispersible Film containing Desloratadine

INTRODUCTION: Orodispersible films (ODFs) are new generation dosage forms that increase patient compliance providing ease of drug administration in many patient groups such as pediatric, geriatric patients and patients with physiological and psychiatric disorders. The purpose of this study was to carry out preliminary studies to develop ODF containing poorly water soluble and oxidation sensitive drug Desloratadine (Dl).

METHODS: In this direction formulation and process parameters as well as characterization method were investigated with prepared 20 film formulations manufactured by solvent casting method. The films were characterized in terms of appereance, mechanical properties, thickness, disintegration time and content uniformity. Various strategies have been applied in order to increase chemical stability of Dl in the formulations and therefore to choose suitable antioxidants, morphological and compatibility study using DSC were performed. For increasing drug loading different film composition were also evaluated.
RESULTS: Among the preliminary formulations tested with a casting height of 400 µm homogeneous, good mechanical properties with tensile strenght value between 6,21-10,34 MPa, flexible and a disintegration time less than 60 s ODFs were developed. By increasing the solubility of Dl in the formulation with the selected formulation components, the drug loading capacity was increased by the desired level 3%.
DISCUSSION AND CONCLUSION: One of the enabling formulation, F20, particle free, with a suitable thickness uniformity (RSD=4,6%) and content uniformity (AV=5) films were developed.