Formulation and Comprehensive In Vitro Evaluation of Orally Disintegrating Ketoprofen Tablets Prepared by Direct Compression

Orally disintegrating tablets (ODTs) are solid oral dosage forms designed to disintegrate in the oral cavity within one minute without requiring water, offering significant advantages for elderly individuals, children, and patients with swallowing difficulties. The objective of this study was to formulate and evaluate fast disintegrating tablets containing ketoprofen using the direct compression method and to investigate the influence of different excipients on critical in vitro quality control parameters. Two tablet formulations were prepared, each containing 150 mg of ketoprofen as the active pharmaceutical ingredient. Excipients included croscarmellose sodium, sucrose-calcium phosphate co-processed filler, mannitol, microcrystalline cellulose, magnesium stearate, and talc. Tablets were evaluated for diameter, thickness, weight variation, hardness and in vitro disintegration time. Both formulations demonstrated acceptable physical properties, but the formulation containing microcrystalline cellulose and mannitol showed markedly faster in vitro disintegration time (40.5 ± 3.6 seconds) compared with the formulation prepared with sucrose-calcium phosphate (159.5 ± 18.6 seconds). The results indicate that mannitol is a more suitable filler than sucrose-calcium phosphate for fast disintegrating ketoprofen tablet systems and that 150 mg ketoprofen is an adequate dose for this dosage form.