Synergizing functionality inpharmaceutical applications with co-processed excipients: Anupdated review

Abstract

Co-processed excipients (CPEs) are gaining prominence as versatile ingredients in pharmaceutical formulations,
offering enhanced functionality by combining the properties of multiple excipients into a single material. This
review delves into their preparation methods, such as spray drying, co-precipitation, and agglomeration, which
are designed to improve flowability, compressibility, and compatibility. Their applications are discussed in detail,
particularly in orally disintegrating formulations, where they play a key role in ensuring rapid disintegration,
better mouthfeel, and adequate mechanical strength. In addition, their utility in direct compression for simplified
manufacturing processes and for sustained-release formulations to achieve controlled drug release is explored. The
review also highlights regulatory perspectives, addressing classification, documentation, and approval challenges
associated with these excipients. By connecting formulation science with regulatory requirements, this article
emphasizes the critical role of CPEs in advancing pharmaceutical development