Using PAT to accelerate and optimize the process development - ERP Spain.com - España y América Latina

Full Title: Using PAT to accelerate and optimize the process development of solid dosage forms. Near-infrared spectroscopy (NIRS), as one of the major PAT tools, has attracted lot of attention from the pharmaceutical industry. NIRS can analyze samples without previous pretreatment, therefore reducing or eliminating wet chemistry analysis. During development of the drug product process, each unit operation brings challenges that need to be assessed in order to prevent compromising the quality of the final product. Two examples of real PAT applications are presented in this study. The first case tackles the challenges of process development in an international environment, with different locations for manufacture and traditional analytics. Showing how PAT enables a lean evaluation of the product quality, better understanding and supports process transfer. By means of in-line monitoring of the blending process, at-line content uniformity determination on high number of tablets and by helping the troubleshooting of segregation. The second case describes in-line monitoring by NIRS for assay determination in a wet met media milling process of a nano-suspension. NIRS proved to be a versatile and valuable tool for the pharmaceutical development and manufacturing of solid dosage forms.