EVALUATION OF TWO CRITICAL QUALITY ATTRIBUTES IN THE PRODUCTION OF SOLID DOSAGE FORMS USING NEAR INFRARED SPECTROSCOPY

Abstract

The determination by means of near infrared spectroscopy of critical quality attributes, of interest for the industrial manufacture of pharmaceutical solids, is studied here in order to apply this new methodology more quickly and efficiently as an alternative to conventional methods. The mixing process of the components of an effervescent formula is studied in order to determine the final mixing time in a fast and reliable way, as well as the humidity in intermediate granules of chewable tablets. The objective is to build the quality of the final product, controlling critical quality attributes of intermediate products during the same process by applying Process Analytical Technology (PAT).