THE EFFECT OF MCC GRADE ON THE PHYSICAL PROPERTIES OF ATROPINE SULFATE RAPIDLY DISINTEGRATING SUBLINGUAL TABLETS

Objective. This study was performed to optimize a previously developed Atropine Sulfate Rapidly Disintegrating Sublingual Tablets (AS RDSTs) to enhance tablet’s physical properties and manufacturability. Background. : A previously developed AS RDSTs 8 mg using MCC grade PH-301, (A) as filler, resulted in rapid tablet disintegration, however, on the expense of tablet hardness (A1 and A2). Therefore, a newer MCC grade (UF-702) was investigated in this study. Methods. AS RDSTs 8 mg and weighing 50 mg using MCC grade UF-702 (B), as filler, was manufactured by direct compression. The compression 38 force was normalized before manufacturing. The following physical quality control tests were evaluated and compared to A1 and A2 RDST formulations: powder flowability, hardness, friability, wetting time, water uptake, disintegration time, and content uniformity. Results. Mean±SD of angle of repose were significantly lower (p\u3c0.05) at 42°±2°, 32°± 0.5° forA and B powders mixtures, respectively. Mean±SD of hardness, friability, wetting time, water uptake (%), disintegration time, and content uniformity acceptance value for A1 (1.6±0.05 KgF, 0.09% loss, 11±1 sec, 229±5%, 8.3±0.4 sec, and 3.72 respectively), A2 (3.0±0.3 KgF, 0.009%, 76±6 sec, 186±9%, 238±3 sec, and 2.01 respectively), and B (3.3±0.2 KgF, 0.05% loss, 17.5±1.5 sec, 284±8.1%, 7.6±0.5 sec, and 13.9, respectively). Conclusion. Using MCC grade UF-702, as filler, enhanced AS RDSTs hardness without compromising their physical properties. Grants. This project was partially funded by Saudi Arabian Cultural Mission bench fees