Co-processed excipients demystified

Despite decades of use and escalating availability, co-processed excipients (CPEs) continue to be surrounded by misconceptions. CPEs are physically and functionally different than admixtures of the individual components used in their manufacture, yet appear equivalent when analyzed through various spectroscopic methods. Unlike admixtures, which are discrete particles mixed and remaining structurally independent, CPEs combine the individual components at the particle level yielding an integrated structure with synergistic properties. CPE monograph development and adoption, while desirable, presents some challenges, which has limited the number of monographs specific to CPEs. However, even though there is an absence of monographs for many CPEs, there is regulatory acceptance, demonstrated by the many drug product approvals where CPEs are used in dosage form production. The above points will be explored with the goal of providing a better understanding of CPEs.