Influence of Ambient Moisture on the Compaction Behavior of Microcrystalline Cellulose Powder Undergoing Uni-Axial Compression and Roller-Compaction: A Comparative Study Using Near-Infrared Spectroscopy

• Published in: Journal of pharmaceutical sciences Vol. 94; no. 10; pp. 2301 - 2313
• Main Authors: Gupta, Abhay, Peck, Garnet E., Miller, Ronald W., Morris, Kenneth R.
• Format: Journal Article
• Language: English
• Published: Hoboken Elsevier Inc 01.10.2005; Wiley Subscription Services, Inc., A Wiley Company; Wiley; American Pharmaceutical Association
• Subjects: Biological and medical sciences; Cellulose - chemistry; compact strength; compaction; Drug Compounding - methods; dry granulation; Excipients - chemistry; General pharmacology; granulation; Heckel analysis; Humidity; Medical sciences; microcrystalline cellulose; milling; multivariate analysis; near-infrared spectroscopy; Particle Size; PAT; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Powders; roller compaction; Spectroscopy, Near-Infrared; Tablets; Tensile Strength; three-point beam bending method; Water - chemistry; particle size; near-infrared spectroscopy; PAT; dry granulation; Heckel analysis; microcrystalline cellulose; three-point beam bending method; multivariate analysis; compact strength; compaction; roller compaction; milling; granulation; Microcrystalline material; Compression; Particle size; Pharmaceutical technology; Granulation; Cellulose; Compaction; Powder; Near infrared spectrometry; Humidity; Behavior; Comparative study; Strength
• ISSN: 0022-3549; 1520-6017
• DOI: 10.1002/jps.20430

This study evaluates the effect of variation in the ambient moisture on the compaction behavior of microcrystalline cellulose (MCC) powder. The study was conducted by comparing the physico-mechanical properties of, and the near infrared (NIR) spectra collected on, compacts prepared by roller compaction with those collected on simulated ribbons, that is, compacts prepared under uni-axial compression. Relative density, moisture content, tensile strength (TS), and Young modulus were used as key sample attributes for comparison. Samples prepared at constant roller compactor settings and feed mass showed constant density and a decrease in TS with increasing moisture content. Compacts prepared under uni-axial compression at constant pressure and compact mass showed the opposite effect, that is, density increased while TS remained almost constant with increasing moisture content. This suggests difference in the influence of moisture on the material under roller compaction, in which the roll gap (i.e., thickness and therefore density) remains almost constant, vs. under uni-axial compression, in which the thickness is free to change in response to the applied pressure. Key sample attributes were also related to the NIR spectra using multivariate data analysis by the partial least squares projection to latent structures (PLS). Good agreement was observed between the measured and the NIR-PLS predicted values for all key attributes for both, the roller compacted samples as well as the simulated ribbons. © 2005 Wiley-Liss, Inc. and the American Pharmacists Association