Near Infrared (NIR) Assay and Content Uniformity of Tablets

Robert Mattes 1 , Denise Root 1 , Om Anand 2 , Maria Gerald Rajan 2 , Namrata R. Trivedi 2 , Wen Qu 2 , Yingxu Peng 2 , Yichun Sun 2 , 1 FOSS NIRSystems, Inc., 2 University of Tennessee, Department of Pharmaceutical Sciences

Abstract

Near infrared (NIR) technique for the determination of content uniformity of tablets provides a fast and accurate means of monitoring tablet production that is in step with the FDA Process Analytical Technology (PAT) initiatives. A newly released NIR tablet analyzer was used to determine the content uniformity of tablets, instrument precision and accuracy. Five different batches of chlorpheniramine maleate (CPM) tablets were compressed with drug contents ranging from 0.1 mg to 2.0 mg of CPM per tablet. A similar size and weight of placebo tablets were also compressed from the same excipients used to compress the drug-loaded batches. Ten tablets were randomly selected from each drug-loaded batch and individually tested for drug content with NIR and HPLC in an attempt to separate instrument error from within-batch variability. Hence, a total of fifty tablets were tested for the five drug-loaded batches. For precision analysis of the NIR equipment, five tablets containing 0.1 mg and five tablets containing 0.5 mg CPM were scanned ten times by the tablet analyzer without replacement. The data showed promising results that could relieve laboratory workload from HPLC analysis and bring analysis closer to “real-time” for process monitoring. The total time required to analyze ten tablets from each batch was less than five minutes. The Dedicated Routine Analysis software for determining content uniformity of tablets was used for this study to calculate the percent label claim, percent relative standard deviation (RSD) and pass/fail indication for the content uniformity study.