Abstract

Near-infrared spectroscopy was evaluated as a method for nondestructively discriminating tablets containing an active drug from two placebo tablet formulations inside blister-packaged clinical supplies without removing the tablets from the blind study tablet cards. A custom sampling device was constructed to allow the spectra of individual tablets to be collected. Spectra of 165 tables were acquired over the wavelength range of 400 to 2500 nm. These tablets were of two different sizes and three formulations. The second derivatives of the spectra were calculated and randomly divided into two groups, each containing approximately half the samples. A factor-based library/model was constructed with the use of the second-derivative spectra from one of the groups over the wavelength range from 1600 to 2500 nm. The model was then validated by predicting the identity of the tablets in the remaining group. The identity and formulation of all the tablets were correctly predicted. This model was then used to confirm the identity of thousands of clinical trial samples. Apart from being nondestructive, the NIR method is less labor and time intensive than the previously used TLC assay.

Optical system for tablet variety discrimination using visible/near-infrared spectroscopy

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