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.
Gupta
Abhay
A
Department of Industrial and Physical Pharmacy, Purdue University School of Pharmacy, 575 Stadium Mall Drive, West Lafayette, Indiana 47907-2091, USA.
Peck
Garnet E
GE
Miller
Ronald W
RW
Morris
Kenneth R
KR
D002130:Calcium Phosphates / Q000737:chemistry; D002482:Cellulose; D004339:Drug Compounding; D005079:Excipients; D006245:Hardness Tests; D010316:Particle Size; D011208:Powders; D019265:Spectroscopy, Near-Infrared; D014046:Tolmetin / Q000737:chemistry
D002130:Calcium Phosphates; D005079:Excipients; D011208:Powders; D002482:Cellulose; D014046:Tolmetin; C109691:microcrystalline cellulose