Formulation and Evaluation of Orodispersible Tablet of Desloratadine By Applying Taste Masking Technology
Abstract
Objectives: To develop and optimize taste-masked orodispersible tablets of desloratadine using ion-exchange resin complexation technology for enhanced patient compliance and therapeutic efficacy in allergic rhinitis management. Materials and methods: Drug-resin complexes were prepared using Indion 204 at various ratios and characterized by FTIR and DSC. Orodispersible tablets were formulated using 3² factorial design with Kyron T-314 (0.75-2.25 mg) and sodium starch glycolate (6-12 mg) as independent variables. Response surface methodology optimized hardness and disintegration time. Pharmacokinetic studies compared optimized formulation with marketed tablets in Wistar rats. Results: Indion 204 achieved optimal drug loading (98.4%) at 1:4 ratio with confirmed molecular interactions. Formulation F9 was selected as optimal based on minimal hardness (1.76 Kg/cm²) and rapid disintegration (24.1 seconds) predicted by quadratic models (R² >0.86). F9 demonstrated superior dissolution (95.8% in 15 minutes), enhanced bioavailability (268.13% relative), reduced Tmax (2.17 hours), and excellent stability over six months with acceptable f₂ similarity factors (≥50). Conclusion: The optimized formulation successfully addresses critical compliance issues through effective taste masking and rapid drug delivery, offering significant clinical advantages for pediatric and geriatric populations. This patient-friendly approach demonstrates strong potential for clinical translation and commercial…
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