Characterising APIs is Essential for Combo Drug Formulations

Gathering information and knowledge around the specific patient population and other market conditions, combined with an understanding of stability issues, will allow for a clear development strategy to be outlined and implemented.

Fixed-dose combination (FDC) drugs offer several benefits to drug manufacturers, patients, and caregivers. In containing two or more active ingredients in a defined composition or fixed ratio, they can support the industry in achieving better patient compliance and by extension the overall treatment of diseases. The formulation of FDC drugs is, however, more complex than simply adding one ingredient to another. 

Because many APIs are incompatible, meaning they are less stable in the presence of each other, selecting excipients and processes that reduce the degradation rate and afford the optimal composition and process parameters increases in difficulty as the number of APIs increases. Manufacturers are facing considerable challenges in product formulation and the design of appropriate manufacturing strategies to address stability, dose size and analytical method development. 

Feature contribution by Torkel Gren, Senior Director and Science and Technology Officer at Recipharm

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