As drug manufacturers, every time we add an excipient to a formulation, we need to consider how it will affect the safety and efficacy of a drug product.
Due to the multi-component nature of excipients, their performance is mostly dependent on its intended application. For example a co-processed excipient may enable direct compression of fast-dissoliving tablets, but if its chemical composition or physical properties change within the allowed ranges, there could be an effect on tabletability or disintegration. Though the challenges of incorporating excipients into QbD programmes are numerous and diverse, the benefits that may derive from that are enormous.
Better communication and communication between the drug product manufacturer and the excipients suppliers are crucial to the successful development of robust pharmaceutical products.
https://www.pharmtech.com/view/bringing-excipients-into-the-quality-by-design-paradigm
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