ABSTRACT:
The oral disintegrating tablets (ODTs) containing solid dispersion based montelukast sodium were designed and developed using Quality by Design (QbD) approach. The Montelukast sodium is BCS class II drug having low water solubility and high permeability. To enhance solubility, a solid dispersion technique was employed using urea as a carrier. Among various ratios of drug and carrier, the 1:1 ratio provided the most significant improvement in solubility. The solid dispersion (SD) was characterized using scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC). In the risk assessment process, the Ishikawa fishbone diagram, risk estimation matrix table were constructed to identify the risk factors associated with the development of oral disintegrating tablets. To establish a design space for developing the formulation with the desired properties, the Custom Design response surface methodology was applied. The independent variables selected for the design were microcrystalline cellulose, magnesium stearate, sodium starch glycolate, and mannitol. Sodium starch glycolate, serving as the super disintegrant, reduced the disintegration time as its concentration increased, with the shortest disintegration time recorded at 18.84 seconds and the longest at 46.24 seconds, and the % Drug content 97.64, % Drug release 96.69, Hardness 4.04 kg/cm2 was observed. Consequently, the newly developed montelukast sodium ODT offer a quicker onset of action and improved patient compliance, which are advantageous in the management of asthma.