Development of rivaroxaban orally disintegrating freeze- dried tablets loaded nanomixed micelles for special populations

Abstract Background The oral route is the recommended route of administration of most therapeutic drugs. Unfortunately, due to swallowing difficulties especially for elderly and young patients, conventional oral dosage forms have low patient compliance. To overcome these difficulties, orally disintegrating tablets (ODTs) were presented in this work. Results In this study, the solubility of rivaroxaban (RXB) was enhanced using nano mixed micelles (NMMs). The optimum NMM formula was selected according to the highest drug content (8.00 ± 0.02 mg), clarity upon reconstitution, smallest particle size (PS) (161.50 ± 2.50 nm), lowest polydispersity index (PDI) (0.37 ± 0.01), and optimum zeta potential (ZP) (− 16.13 ± 0.42 mV). The optimized formula was then mixed with different ODT carriers (gellan gum, sodium alginate, and hydroxypropyl methylcellulose) and freeze dried. The ODTs were evaluated via weight variation, thickness and diameter, friability, drug content, in vitro disintegration, swelling profile, in vitro dissolution. The tablet containing 35 mg sodium alginate (SA) and 15 mg gellan gum (GG) was found to fulfill the optimum criteria for ODTs. The in vitro disintegration profile of tablets was evaluated in six human volunteers, revealed a disintegration time ranging from 31.5 ± 1.89 s to 85 ± 3.54 s. Conclusion A promising ODT formulation containing RXB-loaded NMMs has been successfully developed, offering a suitable option for special populations such as the elderly and children who experience difficulty swallowing. This advancement may enhance treatment effectiveness by improving patient compliance.