ILYASU SALIM, GARBA MOHAMMED KHALID, ABUBAKAR SADİQ WADA, SULEİMAN DANLADI, FATİMA SHUAİBU KURFI, MAHMUD SANİ GWARZO
Journal of Research in Pharmacy - 2024;28(5):1704-1719
This research implements a computer-aided formulation development algorithm based on a novel SeDeM-ODT expert system in establishing the design space for paediatric pyridoxine hydrochloride orodispersible tablets (ODTs) using Prosolv® ODTG2, Prosolv® EasyTab SP, and Ludiflash® systems. For each formulation ingredient, expert system-defined preformulation parameter values were experimentally determined according to standardized methods and then normalized to the theoretical radius range [0, 10]. Expert diagrams were constructed and the quantitative performance of each ingredient was evaluated using parametric profile index (IPP), flowability (ff’), and compressibility (ffc) functions. The net direct compression capability was quantitatively expressed as the product of expert system reliability and IPP. Direct compression was conducted in an eccentric tablet press and properties were evaluated using weight, dimension, disintegration test, contact angle, tensile strength, x-ray diffraction, and Fourier-transform infrared spectroscopy. The ODTs dissolution profiles were fitted and compared using zero-order, first-order, Hixson-Crowell, and Hopfenberg models. Results of the expert diagram of pyridoxine hydrochloride indicated suboptimal normalized radii values in 8 out of 12 parameters, implying a compromised mechanical zone (ff’=3.61, ffc=2.11). By setting a target ffc for the optimized formulation mix at 5.0, the predicted proportions of the fillers to remedy the direct compression deficits of the drug were computed as 89.00%, 83.23%, and 76.62% for Prosolv® ODTG2 (ffc=5.36), Prosolv® EasyTab SP (ffc=5.58), and Ludiflash® (ffc=5.88), respectively. The produced ODTs were of acceptable target quality, hence the SeDeM-ODT system was considered a reliable formulation tool for establishing the design space of this particular drug-filler systems.
