Preliminary Study on the Development of Orodispersible Film Containing Desloratadine.

Abstract

Objectives: 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, and patients with physiological and psychiatric disorders. The aim of this study was to conduct preliminary studies to develop ODF containing the poorly water-soluble and oxidation-sensitive drug desloratadine (DL).

Materials and methods: In this study, the formulation and process parameters, as well as the characterization method were investigated using 20 film formulations manufactured by the solvent casting method. The films were characterized in terms of their appearance, mechanical properties, thickness, disintegration time, and content uniformity. Various strategies have been applied to increase the chemical stability of DL in the formulations and, therefore to choose suitable antioxidants, and morphological and compatibility studies using differential scanning calorimetry were performed. For increasing drug loading, different film compositions were also evaluated.

Results: Among the preliminary formulations tested with a casting height of 400 μm, homogeneous, good mechanical properties with tensile strength values between 6.21-10.34 MPa, flexibility, and ODFs with a disintegration time of less than 60s ODFs were developed. By increasing the solubility of DL in the formulation with the selected components, the drug loading capacity was increased to 3% by the desired level.

Conclusion: One of the enabling formulations, F20, was particle-free with a suitable thickness uniformity (relative standard deviation =4.6%) and content uniformity (acceptance values =5) films were developed.