Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble - Seguridad Mania.com - España y América Latina

The use of process analytical technology (PAT) in the pharmaceutical industry has significantly increased as an effect of regulatory guidelines and the transition towards continuous manufacturing of oral solid dosage forms. In the direct compression process, the most common way to assess homogeneity of powder blends is after the final mixing operation, followed by end-point testing of tablets. However, focusing on the homogeneity of powder blends does not consider the potential of segregation during material storage and powder transport and also faces severe sampling issues. Method: In this study, NIR spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. Confirmative transmission Raman spectroscopy measurements on tablets were also made. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested, in order to improve the quality of the NIR measurements. These were made in laboratory settings that simulated in-line measurements in a vertical tube between two blenders and in the feed frame of the tablet press. A model formulation consisting of powder mixtures of a drug substance, mannitol, microcrystalline cellulose (MCC), croscarmellose sodium (NaCMC) and sodium stearyl fumarate (NaSF) was used for the experiments. A design of experiments, where the API was varied at five levels while MCC, NaCMC and NaSF were varied at two levels, was used for the calibration powder blends.