Brittle Fraction Index (BFI) as a tool in the classification, grouping and ranking of binders in tablet formulation: Paracetamol tablets.

ABSTRACT

The aim of this work was to explore the possibility of utilizing BFI as a tool for classifying, grouping and ranking binders based on performance in ameliorating capping and lamination in paracetamol tablets. Binders from different origins (starches, celluloses, natural gums, and synthetic gums) were used via wet granulation at concentrations ranging from 1.0 - 12.5% w/w to make paracetamol tablets with and without centre holes at a compression pressure of 7.5 arbitrary units. Requisite quality control tests were conducted on the tablets. The BFI values of the tablets were computed and statistically analyzed using Friedman’s test and regression analysis. The analyses revealed significant differences between the BFI values of the formulations (p < 0.05), projected BFI as a useful tool in grouping and ranking binders based on effectiveness in ameliorating capping and lamination in paracetamol tablets, but failed to be useful in classifying the binders based on nature or origin. Furthermore, with the exception of some of the tablets formulated with the celluloses or starches, others met the official requirements for good quality and those formulated with plant gums or PVP released up to 70% of drug in 15min at low binder concentrations. The present findings may serve as a guide to formulators since they may enable quick and easy selection of the best and most economic binder(s) from an array of available binders for the conversion of paracetamol or related powders into good quality tablets.