LAUSR

Abstract To overcome swallowing problems, particularly among the aging population, oral disintegrating tablets (ODTs) have been developed to disintegrate instantly in saliva. Here we developed novel diclofenac sodium ODTs by freeze drying and evaluated their efficacy using in vitro and in vivo tests. A sugar alcohol, mannitol, sorbitol, or xylitol, was used as the excipient and tamarind (Tamarindus indica) seed gum (crude or modified forms) was used as a binder in the freeze-dried tablets. Tablets with appropriate portions of the sugar alcohol (30–60 mg) and gum (50–100 mg) showed a good appearance. However, those containing mannitol had better appearance and integrity and were easier to remove from molds than those containing sorbitol or xylitol. The tablet properties thickness, diameter, and weigh variation were controlled to monitor tablet quality. The ODT formulation containing diclofenac sodium, polyethylene glycol (PEG) 4000, modified tamarind seed gum, and mannitol showed the shortest disintegration time (less than 2 min) in phosphate buffer (pH 6.8). Moreover, this formulation achieved 100% drug release in less than 6 min. These data warant the application of freeze drying using gum as a binder for the fabrication of ODTs containing heat-sensitive active pharmaceutical ingredients.