Development and evaluation of a novel, multifunctional, coprocessed excipient via roller compaction of α-Lactose Monohydrate and Magnesium Silicate

Abstract

This study investigates co-processing lactose with synthetic amorphous magnesium silicate with the aim of expanding the use of directly compressible excipients based on native lactose. The co-processing was performed using roller compaction. The co-processed excipient was characterized using particle size analysis and compression properties (Kawakita equation). The co-processed excipient demonstrated plastic behavior upon compression, good flowability and crushing strength and a shorter disintegration time. Compatibility between the different ingredients of the co-processed excipient, as well as, between the co-processed excipient and model drugs was tested using Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared spectroscopy (FTIR). The interaction between lactose and magnesium silicate proved to be of a physical nature. Formulating this co-processed excipient with Mebeverine HCl and Losartan Potassium as model drugs, indicated its suitability as a single multi-functional excipient. Co-processed lactose with magnesium silicate could be used as a single direct compression excipient for tablet manufacturing.