Roll compaction of pharmaceutical excipients and prediction using intelligent software

• Main Author: Mansa, Rachel Fran
• Published: University of Birmingham 2007
• Subjects: 006.3; TP Chemical technology
• Online Access: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.442643

Roll compaction is a dry granulation method. In the pharmaceutical industry it assists in binding tablet ingredients together to form a larger mass. This is conducted to ease subsequent processing, decrease dust, improve flowability, improve material distribution, more suitable for moisture and heat sensitive materials than wet granulation methods, minimises operating space and suited for a continuous manufacturing set-up. In pharmaceutical roll compaction various types of powder material mixtures are compacted into ribbon that are subsequently milled and tableted. The aim of this research is to investigate the use of intelligent software (FormRules and INForm software) for predicting the effects of the roll compaction process and formulation characteristics on final ribbon quality. Firstly, the tablet formulations were characterised in terms of their particle size distribution, densities, compressibility, compactibility, effective angle of friction and angle of wall friction. These tablet formulations were then roll compacted. The tablet formulation characteristics and roll compaction results formed 64 datasets, which were then used in FormRules and INForm software training. FormRules software highlighted the key input variables (i.e. tablet formulations, characteristics and roll compaction process parameters). Next these key input variables were used as input variables in the model development training of INForm. The INForm software produced models which were successful in predicting experimental results. The predicted nip angle values of the INForm models were found to be within 5%, which was more accurate to those derived from Johanson’s model prediction. The Johanson’s model was not successful in predicting nip angle above the roll speed of 1 rpm due to air entrainment. It also over-predicted the experimental nip angle of DCPA and MCC by 200%, while the approximation using Johanson’s pressure profile under-predicted the experimental nip angle of DCPA by 5-20% and MCC by 20%.