In-line monitoring and optimization of powder flow in a simulated continuous process using transmission near infrared spectroscopy

Publication date: 30 June 2017 Source:International Journal of Pharmaceutics, Volume 526, Issues 1–2 Author(s): Md Anik Alam, Zhenqi Shi, James K. Drennen, Carl A. Anderson In-line monitoring of continuous powder flow is an integral part of the continuous manufacturing process of solid oral dosage forms in the pharmaceutical industry. Specifically, monitoring downstream from loss-in-weight (LIW) feeders and/or continuous mixers provides important data about the state of the process. Such measurements support control of the process and thereby enhance product quality. Near Infrared Spectroscopy (NIRS) is a potential PAT tool to monitor the homogeneity of a continuous powder flow stream in pharmaceutical manufacturing. However, the association of analytical results from NIR sampling of the powder stream and the homogeneity (content uniformity) of the resulting tablets provides several challenges; appropriate sampling strategies, adequately robust modeling techniques and poor sensitivities (for low dose APIs) are amongst them. Information from reflectance-based NIRS sampling is limited. The region of the powder bed that is interrogated is confined to the surface where the measurement is made. This potential bias in sampling may, in turn, limit the ability to predict the homogeneity of the finished dosage form. Further, changes to the processing parameters (e.g., rate of powder flow) often have a significant effect on the resulting data. Sample representation, interdepend...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research