A novel method for analyzing thick tablets by near infrared spectroscopy

Abstract

A near-infrared (NIR) spectroscopic method to determine content uniformity of a large, thick tablet using an approach that could facilitate future validations has been developed. A CT ibuprofen 800-mg tablet weighs about 1150 mg and is about 18.6 mm wide and 7.6 mm thick. The FT NIR spectrometer was optimized for transmission spectra of the tablets by moving it to the sample compartment and placing it immediately behind the tablet. In spite of this dedicated setup, the transmission spectra obtained were very poor, indicating that the NIR radiation was not reaching the detector. The spectra of the tablet improved with use of a simple preparation in which a flat-face die applies pressure of 20 000 psi to the tablet; this reduced the thickness of the tablet from 7.6 mm to 3.6 mm. A calibration model was developed for tablets with drug content ranging from 70% to 130% of label. The calibration model was tested using a validation set of tablets with a drug content of 752, 800, and 848 mg. The results obtained were within 1.5% of the known drug content of the validation set tablets. Even with the sample preparation, the content uniformity results of 10 tablets could be determined using this method in less than 1 hour. The approach described in this article could also be used to validate NIR content uniformity methods for other formulations.

Quantitation of drug content in a low dosage formulation by transmission near infrared spectroscopy

“…This observation has been made in other studies involving transmission NIRS, with the consequence that calibration models for transmission have been developed with the higher frequency part of the spectrum. 9,14 PLS is a full-spectrum method that requires that the component modeled absorb in the spectral range used to develop the calibration model. 15 Conformance to this requirement was verified by compressing a tablet with a thickness of 1.6 mm at 2000 psi in a Carver single-punch press (Wabash, IN), where ibuprofen was the sole component, then obtaining the spectrum labeled ibuprofen 100% in Figure 2.…”

Simultaneous Quantification of Paracetamol and Caffeine in Powder Blends for Tableting by NIR-Chemometry

“…In the spectral region with wavelengths less than 4000 cm −1 , the amount of radiation reaching the detector is reduced, background noise is high, and therefore it was eliminated from the analysis. Eliminating these spectral regions was carried out by other researchers too, who found similar results [20,21]. Thus, model development for paracetamol assay was done using the spectral regions 9000-4000 cm −1 .…”

Validation of manufacturing process of Diltiazem HCl tablets by NIR spectrophotometry (NIRS)

“…1. The region above 7000 cm −1 was selected because below this wavenumber the amount of light reaching the detector is low and the detector signal becomes noisy [13,14]. Validation (RMSECV) of 0.272 mg.…”