Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy.

Compact strength and the particle-size distribution of milled roller compacted compacts were correlated to the slope of the best-fit line through near-infrared spectra for samples prepared under different roll speeds and feed rates. The above correlations were found to hold for compacts prepared from microcrystalline cellulose powder as well as from a typical direct compression pharmaceutical powder blend containing tolmetin sodium dihydrate, microcrystalline cellulose, and dicalcium phosphate dihydrate. Near-infrared spectra were also collected real time for the compacts prepared from the tolmetin powder blend. The real-time slope values for the spectra showed good agreement with the off-line data. The strength of compacts was determined using three-point beam bending method and the particle-size distribution of the milled compacts was determined using sieve analysis. The results suggest that the real-time values of the slope of the best-fit line through the near-infrared spectrum offers a robust, yet simple and fast quality control tool to monitor/control manufacturing and scale-up processes involving dry granulation by roller compaction. Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.