A NEAR-INFRARED REFLECTANCE ANALYSIS METHOD FOR THE NONINVASIVE IDENTIFICATION OF FILM-COATED AND NON-FILM-COATED, BLISTER-PACKED TABLETS

摘要

A non-invasive near-infrared reflectance analysis (NIRA) method has been developed to confirm the identity of blister-packed, film-coated and non film-coated tablets for clinical trial supplies. NIR spectra of the tablets were measured through the blister pack plastic using a fiber optic probe. The blister packs contained 18 cells which held pink, pentagonal tablets or film-coated, white, oblong tablets. The pink tablets contained about 80% w/w of a marketed drug as a clinical comparator or were matching placebos. The white film-coated tablets contained about 60% w/w of an experimental drug, about 75% w/w of a marketed drug as a clinical comparator, or were matching placebos. Pattern recognition methods were developed to identify tablets in the blister pack by using libraries of second derivative NIR spectra of each tablet-type. Three chemometric methods were used, the wavelength distance method, SIMCA residual variance method, and Mahalanobis distance method. The methods were tested with full spectra (1100-2350 nm) and three subset wavelength ranges. Several of the methods reported here reliably discriminate between film-coated and non film-coated tablets, and between active and placebo tablets. Library validation and test set data are presented along with a discussion of the advantages and disadvantages of selecting subset wavelength regions. [References: 17]