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Process analytical technologies and injectable drug products: Is there a future?
João Henriques1, João Sousa2, Francisco Veiga2
1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
International Journal of Pharmaceutics
|November 4, 2018
Summary
Parametric release, a subset of real-time release testing, offers an alternative to traditional sterility testing for injectable drugs. Quality by Design (QbD) principles and Process Analytical Technologies (PAT) like NIRS and Raman spectroscopy are key to its implementation.
Area of Science:
- Pharmaceutical Sciences
- Process Analytical Technology (PAT)
- Quality by Design (QbD)
Background:
- Parametric release, an early form of real-time release testing (RTRT), was developed for terminally sterilized injectable drug products.
- It aims to provide an alternative to costly and time-consuming sterility testing without compromising product safety.
- The underlying principle is Quality by Design (QbD), emphasizing that quality is built into the product, not tested in.
Purpose of the Study:
- To present a framework for implementing the QbD approach in injectable formulation development and manufacturing.
- To explore the application of Process Analytical Technologies (PAT), specifically Near Infrared Spectroscopy (NIRS) and Raman spectroscopy, in this context.
- To address the limited application of NIRS and Raman spectroscopy in injectable drug product development.
Main Methods:
- Review of existing literature and methodologies for parametric release and QbD implementation.
- Discussion of risk assessment tools and factorial design principles relevant to pharmaceutical development.
- Analysis of the practical application of PAT tools, including NIRS and Raman spectroscopy, for injectable drug product analysis.
Main Results:
- Parametric release offers a viable alternative to traditional sterility testing by integrating quality control within the manufacturing process.
- Quality by Design (QbD) principles, supported by Process Analytical Technologies (PAT), are crucial for successful parametric release.
- Near Infrared Spectroscopy (NIRS) and Raman spectroscopy show promise as versatile PAT tools for injectable drug product analysis, despite limited current application.
Conclusions:
- Implementing QbD and PAT is essential for the successful adoption of parametric release for injectable drug products.
- NIRS and Raman spectroscopy represent valuable tools for in-process monitoring and quality control, enhancing efficiency and product quality.
- Further research and practical application are needed to fully leverage the potential of PAT in injectable drug manufacturing.
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