Application of Near-Infrared Spectroscopy for Nondestructive Analysis of Avicel® Powders and Tablets

Abstract

The purpose of this study was to use near-infrared spectroscopy (NIRS) as a nondestructive technique to (a) differentiate three Avicel products (microcrystalline cellulose [MCC] PH-101, PH-102, and PH-200) in powdered form and in compressed tablets with and without 0.5% w/w magnesium stearate as a lubricant; (b) determine the magnesium stearate concentrations in the tablets; and (c) measure hardness of tablets compressed at several compression forces. Diffuse reflectance NIR spectra from Avicel powders and tablets (compression forces ranging from 0.2 to 1.2 tons) were collected and distance scores calculated from the second-derivative spectra were used to distinguish the different Avicel products. A multiple linear regression model was generated to determine magnesium stearate concentrations (from 0.25 to 2% w/w), and partial least squares (PLS) models were generated to predict hardness of tablets. The NIRS technique could distinguish between the three different Avicel products, irrespective of lubricant concentration, in both the powdered form and in the compressed tablets because of the differences in the particle size of the Avicel products. The percent error for predicting the lubricant concentration of tablets ranged from 0.2 to 10% w/w. The maximum percent error of prediction of hardness of tablets compressed at the various compression forces was 8.8% for MCC PH-101, 5.3% for MCC PH-102, and 4.6% for MCC PH-200. The NIRS nondestructive technique can be used to predict the Avicel type in both powdered and tablet forms as well as to predict the lubricant concentration and hardness.

Application of a novel combination of near-infrared spectroscopy and a humidity-controlled 96-well plate to the characterization of the polymorphism of imidafenacin

“…Chemometric NIR spectroscopy [9] is rapidly becoming an important technique and has many uses in the pharmaceutical industry, for example quantitative drug analysis, [10] drug stability, [11] polymorphic quantitification of pharmaceuticals, [12–16] particle size distribution [17–22] and tablet mechanical strength [23–27] …”

A Near-Infrared Spectroscopic Investigation of Relative Density and Crushing Strength in Four-Component Compacts

“…Drennen and Lodder pioneered the use of NIRS for the measurement of tablet hardness 4, 11. Subsequently, numerous publications have demonstrated NIR calibrations for crushing strength 3–8, 12–24. The majority of these articles suggest that an increase in tablet hardness results in a smoother tablet surface, increasing apparent NIR absorption (presumably because more light is lost to specular reflectance).…”

Near-infrared spectroscopy for nondestructive evaluation of tablets

“…They also successfully developed a method for the determination of magnesium stearate by a multiple linear regression method. [11] Chen et al predicted theophylline content of intact tablets by NIR spectroscopy. Artificial neural network and partial least-squares models were used to predict the drug content.…”

“…The error of prediction was found to be 8.8%, 5.3%, and 4.6% for MCC PH 101, MCC PH 102, and MCC PH 200, respectively. [11] Otusuka et al used NIR chemometrics to study the effect of lubricant mixing on tablet hardness. Two formulations were prepared for the evaluation.…”