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
Highlights
IntroductionSucrose is one of the most commonly used raw materials in pediatric formulations and it is usually involved in granulation processes with different purposes
Sucrose is one of the most commonly used raw materials in pediatric formulations and it is usually involved in granulation processes with different purposes.In particular, it can act as a diluent, binder and as a taste masking agent, sweetener and for production of Sucrose is soluble and sticky excipient and its manipulation in high shear granulators may be very difficult because it can adhere to the mixer walls or lead to an uncontrolled granule growth
partial least square (PLS) is recommended in the literature as suitable approach for modeling of large processes, with serious multicolinearity, numerous variables and specific information for different parts of the processing which will be lost if all data are not examined simultaneously (Westerhuis, 1997; Westerhuis and Coenegracht, 1997)
Summary
Sucrose is one of the most commonly used raw materials in pediatric formulations and it is usually involved in granulation processes with different purposes. It can act as a diluent, binder and as a taste masking agent, sweetener and for production of Sucrose is soluble and sticky excipient and its manipulation in high shear granulators may be very difficult because it can adhere to the mixer walls or lead to an uncontrolled granule growth. The amount of liquid binder depends on the physico-chemical properties of the raw material for granulation, and on the raw material-liquid binder interaction and the process variables like impeller speed, granulation liquid addition rate, wet massing time etc. Moisture adsorption on the sucrose particle surface can induce deliquescence and formation of liquid viscous bridges which cause sticky behavior of the wet mass (Santomaso et al, 2017)
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