Morphological Comparison of Pharmaceutical Excipients

Under current ICH Q10 guidelines, companies should be pursuing continuous improvement to their pharmaceutical products. Changing the supplier of a given excipient can be a question of quality risk management and cost. By having alternative suppliers, the company can reduce risks in the supply chain, but will need to demonstrate compatibility with the existing manufacturing process. This application note shows comparable particle morphology of an excipient from two suppliers, which supported the similar performance seen in tablet disintegration tests. The proposed alternative supplier priced the excipient significantly lower than the current supplier potentially leading to a significant reduction in cost of manufacture of the pharmaceutical product if the risk of change is found to be minimal.


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