Preparation and evaluation of celecoxib lyophilized orally disintegrating tablets with high bioavailability.

This study aimed to develop industrially feasible nano-lyophilized orally disintegrating tablets of celecoxib with high bioavailability and rapid onset of action. Nano-lyophilized orally disintegrating tablets were prepared using a media milling method combined with freeze-drying technology, in which the particle size of celecoxib was at the nanoscale. Single-factor experimental design and Box-Behnken statistical experimental design optimized the process and formulation. The optimized formulation contained 49.5 % celecoxib, 11.3 % PVP K30, 2.6 % SDS and 36.6 % mannitol. The tablets disintegrated within 5 s, with an average drug particle size of 351 nm after dispersion. The solubility of celecoxib increased significantly across all tested pH levels. In vitro release studies demonstrated that over 90 % of celecoxib was released from the tablets within 3 min. In vivo studies in rats and beagle dogs showed relative bioavailabilities of 155 % and 292 %, respectively, compared to Celebrex®, and tmax was reduced by 25.5 % and 33.5 %. The study successfully developed a nanotechnology-based lyophilized orally disintegrating tablet of celecoxib with enhanced bioavailability, offering a promising approach for low-dose NSAID formulations.