Many APIs are not amenable to easily achieved desirable critical powder material properties via tweaking crystallization processes or by developing a suitable alternate polymorph. In such cases, API co-processing may be a potentially beneficial approach. There are many options for co-processing even within dry or wet routes, for example, concurrent crystallization/ precipitation of the API and nonactive components, controlled crystallization via adsorption/addition of non-actives, surface modification, dry mechanical coating, or adsorption or impregnation of carriers. This presentation will include a brief review of some of the major approaches used in wet or dry API co-processing followed by further details of dry co-processing. Examples of the APIs co-processed with inert or nonactive materials such as the excipients or additives will be presented to potentially achieve better physical properties such as reduced cohesion hence improved flowability, increased bulk density, reduced agglomeration, and enhanced dissolution even when hydrophobic coatings are applied. The synergistic enhancements in the blend or formulation properties will be highlighted including blend uniformity, flowability, compaction properties, and enhanced capability for direct compaction tableting at higher drug load or very low drug loadings. A major positive feature of the dry co-processed APIs is the possibility of model-based predictive enhancements and digital design of their formulations because of the availability and applicability of mechanistic particle contact models. Such results and simplicity of this approach indicate the potential for this to become a major platform technology. Notwithstanding, there is a need to better articulate the regulatory expectations for this and other API co-processing and it is hoped this presentation will lead to future discussions and considerations.
Learning Objectives:
Upon completion, participants will become familiar with major approaches used in wet/dry API co-processing.
Upon completion, participant will learn about additives/excipients/carrier materials used, their characterization, critical material properties, and predictive design of co-processed API formulations that enable expanded design space for direct compression.
Upon completion, participant will appreciate the need for developing regulatory strategies and associated science including if co-processed APIs should be considered as drug substances.