Process analytical technologies and injectable drug products: Is there a future?

Affiliation

Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Center for Neurosciences and Cell Biology (CNC), University of Coimbra, Rua Larga, Faculty of Medicine, Pólo I, 1st Floor, 3004-504 Coimbra, Portugal; REQUIMTE/LAQV, Group of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal. Electronic address: [Email]

Abstract

Parametric release was the first subset of real time release testing (RTRT), applied to terminally sterilised injectable drug products. The objective was to offer the industry an alternative to the time and money consuming sterility testing, without compromising the sterility of the products. The rationale was that quality cannot be tested into products, instead it must be planned (the principle of quality by design, QbD). This can be implemented by setting appropriate in-process controls supported on process analytical technologies (PAT). Two of the most versatile and promising PAT tools are the near infrared spectroscopy (NIRS) and the Raman spectroscopy. However, their application to injectable drug product development and manufacturing has been scarce. This review has the objective to provide a framework for the practical implementation of the QbD approach to injectable formulations, including application of diverse risk assessment and factorial design tools. Finally, the actual application of PAT, namely NIRS and Raman spectroscopy, to injectable drug product analysis is addressed.

Keywords

Injectable formulation,Parametric release,Process analytical technology,Quality by design,Real-time release testing,Risk assessment,

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