Texture Analyzer-Derived SeDeM-ODT Extension for Bisoprolol Fumarate Orodispersible Tablets: Formulation...

Background/Objectives: Conventional SeDeM-ODT screening relies on physicochemical properties and endpoint disintegration tests, which may have limited discriminatory power among formulations that already meet pharmacopoeial disintegration requirements. This study aimed to extend SeDeM-ODT by incorporating texture analyzer-derived descriptors of low-volume liquid disintegration behavior. Methods: Bisoprolol fumarate was used as a low-dose model drug. Selected excipients were characterized using SeDeM and conventional SeDeM-ODT approaches. Texture analyzer distance-time profiles were used to derive swelling efficiency (SE), residue height (RH), and structural transition efficiency (STE), which were converted into SeDeM-compatible parameters. Orodispersible tablets were developed using a two-factor central composite design and evaluated for mechanical properties, pharmacopoeial disintegration, comparative dissolution performance, texture analyzer behavior, and supportive Heckel parameters. Results: All formulations met the pharmacopoeial disintegration criteria and showed rapid drug release under the applied dissolution conditions. Conventional endpoint-based responses showed limited discriminatory value within the investigated formulation space. In contrast, SE, RH, and STE differentiated formulation-dependent swelling, residual structural persistence, and transition toward structural collapse under low-volume liquid controlled-force conditions. MCC-rich formulations generally retained greater residual structure, whereas lactose-rich and/or higher-superdisintegrant formulations showed lower residual persistence. Comparative kinetic fitting and Heckel analysis supported these interpretations but did not independently establish a definitive disintegration mechanism. Conclusions: Incorporating low-volume liquid texture analyzer-derived parameters into SeDeM-ODT improved the comparative interpretation of excipient and formulation behavior. These findings suggest that pharmacopoeial disintegration compliance may coexist with distinct structural pathways not fully captured by conventional endpoints.