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

• Published in: Journal of pharmaceutical sciences Vol. 93; no. 4; pp. 1047 - 1053
• Main Authors: Gupta, Abhay, Peck, Garnet E., Miller, Ronald W., Morris, Kenneth R.
• Format: Journal Article
• Language: English
• Published: Hoboken Elsevier Inc 01.04.2004; Wiley Subscription Services, Inc., A Wiley Company; Wiley; American Pharmaceutical Association
• Subjects: Biological and medical sciences; Calcium Phosphates - chemistry; Cellulose; compact strength; compaction; Drug Compounding; dry granulation; Excipients; General pharmacology; granulation; Hardness Tests; Medical sciences; milling; near-infrared spectroscopy; Particle Size; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Powders; Process Analytical Technology (PAT); roller compaction; Spectroscopy, Near-Infrared; three-point beam bending method; Tolmetin - chemistry; particle size; near-infrared spectroscopy; Process Analytical Technology (PAT); dry granulation; compact strength; compaction; three-point beam bending method; roller compaction; milling; granulation; Measurement; Particle size; Powder; Near infrared spectrometry; Powder compact; Distribution; Strength
• ISSN: 0022-3549; 1520-6017
• DOI: 10.1002/jps.20003

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.