Formulation and Delivery
Catherine Sheehan, DRSc. MS. MS.
Senior Director, Excipients and Foods
U.S. Pharmacopeia (USP)
Rockville, Maryland
Chris Moreton, PhD (he/him/his)
Partner
FinnBritt Consulting
Waltham, Massachusetts
Excipients are used in virtually all drug products and are essential for product development, manufacture, performance, and their quality are essential to global supply of safe and efficacious medicines. However, with continuous advancements in novel and therapeutic biological drugs, the use of new and complex excipients such as complex polymers used in complex generic drugs, phospholipids in lipid nanoparticle type vaccines and other biological drugs, and introduction of novel excipients as part of a new drug product’s development, characterization of excipients becomes more challenging using conventional QC/ compendial methods. Additionally, since excipients are globally sourced from an increasingly more complex supply chain that continues to be at a high risk for adulteration and contamination, USP-NF public standards play a key role in establishing the quality of excipients and can help ensure an excipient is fit for intended use. Furthermore, an excipient may be used in different ways or for different purposes in a formulation and may require control of different material properties to achieve the desired performance not specified in a monograph. Subsequently, the use of USP information chapter, Excipient Performance <1059> and other test chapters, offer a solutions approach that may help excipient suppliers and users to identify and control critical excipient material properties. USP’s engagement with key stakeholders including industry, global regulators, and the Pharmacopeial Discussion Group helps to promote global pharmacopeial standardization and implementation of quality excipients fit for intended use.