Abstract

This study hypothesized that the tensile strength of placebo tablets produced from newly engineered α-lactose-starch orodispersible composite using a single-punch tablet press was dependent on the combined effects of magnesium stearate concentration, tumbling speed of a double cone mixer, and the duration of mixing. A 2x3 full factorial experiment was designed to: (i) understand the main effects associated with each of the factors, and (ii) to understand the interactions between the factors using main effect, interaction, pareto, cube, response surface plots, and regression modelling tools of Minitab® 19 (Minitab Limited, United Kingdom). The main effects plots indicated that the tensile strength of the novel α-lactose-starch orodispersible composite increases at low factor settings of magnesium stearate concentration, and low tumbling speed, but diminishes at low settings of mixing time. Conversely, for mixing time the effect on tensile strength was greater at the high setting. Conclusively, the magnesium stearate concentration, tumbling speed of a double cone mixer, and the duration of mixing are critical factors affecting the tensile strength of the α-lactose-starch orodispersible composite, suggesting further optimization in future formulation design.

Key words: Orodispersible Excipients; Full Factorial Design; Process Analytical Technology; Tensile Strength; Material Science