Physical Properties of Granules Containing Polysorbate 80

Abstract

The friability and crushing load of granules containing polysorbate 80 were determined. It was found that while polysorbate 80 decreased granule hardness, as indicated by the load required to crush it, friability values increased to a maximum then decreasing at higher polysorbate 80 concentration. Thus the use of granule friability to measure granule strength may be erroneous unless good correlation between granule friability and direct crushing weight was obtained.

Direct measurement of granule strength tends to vary with granule shape and size giving a rather wide scatter of results. For overcoming this difficulty, tablet triturates could be prepared and the crushing strength determined. The crushing strength of the tablet triturates was found to be similar to that of granules but with a smaller scatter and more easily handled.

Studies of other physical properties of the granules containing polysorbate 80 were also made. Small amounts of the nonionic surfactant (0.002 - 0.2%) generally improved granule fluidity as characterised by the orifice flow velocity and the angle of repose of the granules.