NEAR-INFRARED METHODS FOR THE IDENTIFICATION OF TABLETS IN CLINICAL-TRIAL SUPPLIES

Near-infrared reflectance analysis (NIR) methods have been developed f or the confirmation of the identity of blister-packed tablets for clin ical trial supplies. Three approaches are described: (1) presentation of single exposed tablets from blisters directly to the optical window ; (2) presentation of unopened opaque blister-packed tablets directly to the optical window of the NIR instrument; and (3) use of a fibre-op tic accessory to examine tablets through unopened opaque blister packs . For clinical purposes, all tablets in this trial were manufactured t o match the appearance of one another. Tablets containing four strengt hs of an experimental drug (2, 5, 10 and 20% w/w of the active), a mar keted product as a clinical comparator (80% w/w of the active), and a placebo were investigated. The NIR methods were developed by chemometr ically building a library with second derivative spectra for each tabl et type. Library validation and lest data are presented along with a c omparison of the three sample presentation techniques. The scope and l imitation of each sample presentation technique are discussed.