Brittle fracture index (BFI) as a tool in the classification, grouping and ranking of some binders used in tablet formulation: Lactose tablets

This work aims at classifying, grouping and ranking binders based on their abilities to ameliorate capping and lamination in lactose tablets using BFI as a tool. Binders from different “families” (for example, starches, celluloses, natural gums, and synthetic gums) were employed via the wet granulation process at concentrations ranging from 1.0 - 12.5% w/w to formulate tablets with and without centre holes at a compression pressure of 7.5 arbitrary units. The tablets dimensions were determined in triplicates, with the resulting values used to calculate their tensile strengths. The means of the tensile strengths were then used to calculate BFI. Analyses of the results were done using Friedman’s test and regression analysis. The analyses revealed that BFI was a useful tool in grouping binders based on their abilities to ameliorate capping and lamination in lactose tablets. It was also useful in ranking the binders based on their levels of effectiveness in solving the problem; however, it was not useful in classifying the binders based on nature or origin since no particular “family” occupied a unique range of BFI values in the task of ameliorating capping and lamination in lactose tablets. The findings from this work will be very helpful to pharmaceutical formulators since the selection of the best and most economic alternative binder(s) from an array of available binders to produce tablets with little or no incidence of capping and lamination will be greatly enabled by them.