Martinez Heredia, Lizbeth, Matero, Sanni, Neumuller, Julie, Juhnke, Michael and Camille, Adler (2021) Process analytical technology as a tool to optimize and accelerate pharmaceutical process development. American Pharmaceutical Review, 24 (4). pp. 28-34.

Abstract

Over the last decades process analytical technology (PAT) has been widely used in the pharmaceutical development to support process understanding and optimization. Among the different technologies, near infrared spectroscopy (NIRS) has maintained its status as a most versatile and valuable PAT tool for probing the manufacturing of solid dosage forms. Two industrial examples of PAT NIRS applications are presented in this paper. The first case tackles the challenges of process development in an international environment, with different locations for manufacture and traditional analytics. The study shows how it was possible to troubleshoot segregation by means of in-line monitoring of the blending process combined to an at-line content uniformity determination on high number of tablets. The second case describes in-line monitoring by NIRS for assay determination in a wet met media milling process of a nanosuspension.

Item Type:	Article
Keywords:	PAT, wet media milling, segregation, NIR
Date Deposited:	27 Jul 2021 00:45
Last Modified:	27 Jul 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44884