Excipients, often referred to as “inactive” ingredients, are a crucial component of pharmaceutical products. They make up a significant portion of the final drug product, often up to 90%, and play a vital role in ensuring the effectiveness and stability of medications. Despite their importance, excipients are frequently overlooked, and their quality is often taken for granted. However, ensuring the quality of excipients is essential for maintaining patient safety and ensuring the resilience of the medicines supply chain.
The Importance of Excipient Quality
Excipients are responsible for various functions in pharmaceutical products, including binding, disintegrating, solubilizing, coating, preserving, coloring, and flavoring. These functions are critical to the delivery and effectiveness of the active pharmaceutical ingredient (API). For instance, excipients can help ensure that the API is released at the right rate and in the right amount, thereby achieving the desired therapeutic effect.
The quality of excipients is critical because it directly impacts the quality of the final drug product. Substandard or contaminated excipients can lead to ineffective or even dangerous medications. This is evident from recent incidents where contaminated excipients resulted in the deaths of children who received impacted cold syrups in The Gambia, Indonesia, and Uzbekistan.
Risk-Based Approach to Excipient Quality
To mitigate these risks, a risk-based approach to excipient quality is necessary. This involves identifying high-risk excipients, such as glycerin, propylene glycol, and solutions of maltitol or sorbitol, which are more prone to contamination. By focusing on these high-risk excipients, manufacturers can allocate resources more efficiently and ensure that these critical components are rigorously evaluated to safeguard the quality of the final drug product.
Supplier Qualification and Harmonized Standards
Supplier qualification is another essential aspect of ensuring excipient quality. Manufacturers must qualify their suppliers to ensure that they are providing high-quality excipients. Harmonized standards and regulations, such as those developed by the European Union, also play a crucial role in ensuring excipient quality. These standards provide a framework for manufacturers to follow, ensuring that excipients are manufactured according to good manufacturing practices (GMPs).
The Role of Excipient Certification Schemes
Excipient certification schemes, such as EXCiPACT, are also playing an increasingly important role in assuring the quality and purity of excipients. These schemes provide a third-party verification of excipient quality, giving manufacturers and regulators confidence in the quality of the excipients used in pharmaceutical products.
The Future of Excipient Quality
As the complexity of excipients continues to evolve, the potential risks associated with them will also increase. To address these risks, the industry must adopt a proactive approach to excipient quality. This involves not only monitoring and controlling the quality of excipients but also understanding their physiochemical properties and ensuring that they are manufactured according to GMPs.
Conclusion
Ensuring the quality of excipients is critical to maintaining patient safety and ensuring the resilience of the medicines supply chain. By adopting a risk-based approach, qualifying suppliers, and implementing harmonized standards and regulations, manufacturers can ensure that their excipients meet the highest standards of quality. As the industry continues to evolve, it is essential that we think differently about excipient quality and take a proactive approach to addressing the risks associated with these critical components.
“Understanding the physiochemical properties of novel and complex excipients is important in determining their functional use, because excipient functionality is a critical quality attribute.” — Yognandan Pandya, USP Director, Industry Programs, Excipients and Special Projects
References
- USP. (2020, November 30). Importance of Excipient Testing & Quality | USP – YouTube.
- USP. (2023, June 6). Thinking differently about excipient quality to ensure medicines supply chain resilience.
- Outsourcing-Pharma. (2021, November 2). Excipients play key role in pharmaceutical innovation: Croda.
- Colorcon. (2023, October 31). Ensuring Quality, Hardness, and Suitability for Film Coating.
- USP. (2017, June 30). Why Excipient Quality Matters – YouTube.
