Cellactose® a Co-processed Excipient: A Comparison Study

Abstract

This article describes the differences in compaction properties between microcrystalline cellulose (MCC) and α-lactose monohydrate physical mixture, and microcrystalline cellulose co-processed with α-lactose monohydrate (Cellactose®). The different compaction parameters are not only compared for the pure materials but also for the lubricated powders with magnesium stearate. Magnesium stearate does not facilitate the densification of either the physical mixture or Cellactose during compaction. The difference in tablet relaxation of the physical mixture and Cellactose indicates that the negative effect of the lubricant on the interparticle bonding of Cellactose particles is smaller than the physical mixture particles because after compaction, the structure in the Cellactose tablet is completely different from that in the physical mixture tablet. However, a larger increase in tablet relaxation at a high compression speed was found for both Cellactose and the physical mixture at different lubricant concentrations: 1.0% and 0.0%. Accordingly, the decrease in tablet strength was larger for the physical mixture tablets than for the Cellactose tablets when lubrication was applied. The examination of the tablet strengths of tablets compressed from physical mixtures of different ratios of α-lactose monohydrate and MCC proved the positive effect of cellulose on the tensile strength of tablets. Co-processing of MCC with α-lactose monohydrate showed extra contribution on the tablet strength of a physical mixture with the same mixing ratio. This extra contribution of Cellactose was attributed only to the interfacial attraction of the particles.