Published Paper Details:

This study aimed to develop and optimize Oro-Dispersible Tablets (ODTs) of Bilastine, a second-generation antihistamine, using Cotton Candy (CC) and Direct Compression (DC) methods. Bilastine ODTs were formulated with varying concentrations of superdisintegrants, sweeteners and lubricants. The CC method utilized a novel approach of incorporating Bilastine into partially recrystallised granules prepared from cotton candy fibers, while the DC method employed a conventional tableting process. Formulations were evaluated for disintegration time, wetting time, hardness, friability, and in vitro drug release. Optimization was achieved through a Design of Experiments (DoE) by using Central Composite Design (CCD) approach, resulting in ODTs with disintegration times of < 30 seconds and drug release > 90% in 10 minutes. The generated batches were prepared and evaluated. The BLS6 was given as the best batch by the design expert software using central composite design (CCD). In-vitro drug release of the optimized formulation (BLS6) was obtained 98.83 % in 10 min and disintegration time within 13.00 seconds. Characterization studies revealed that CC-ODTs exhibited faster disintegration and superior drug release profiles. These findings demonstrate the potential of Cotton Candy technology in developing rapid-disintegrating, high-performance ODTs of Bilastine, offering improved patient compliance and therapeutic outcomes.