Determination of significant factors in high-shear granulation process of sucrose with aqueous solution of sodium lauryl sulphate using partial least square regression approach

Abstract

Sucrose as one of the most commonly used raw materials in pediatric formulations is soluble and sticky excipient and its manipulation in high shear granulators may be very difficult. Therefore, to determine the correct amount of liquid binder is very important because it falls in a very narrow range and may vary due to small variations in the material properties or environmental conditions. The possibility of using the sugar as powder for granulation may be very challenging because of solubility and moisture adsorption properties of crystalline sugar, especially if the binder solution is water. The aim of this study was trying to solve these problems and produce sucrose granules using high share granulation and water as a binding liquid, with properties required for final product good performance. By reducing the sucrose particle size and improving the uniformity of the size distribution, the differences of the processes of nucleation and growth for small and large particles might be reduced. According to the variable importance or VIP scores from the developed partial least square (PLS) model, raw material particle size is as influential variable as the quantity and composition of the granulation liquid (Gra), granulation time (Grn) and impeller rate (Imp). Keywords: sucrose, particle size distribution, high-shear granulation, partial least square