Introduction
Excipients are integral components of pharmaceutical drug formulations; they are defined as substances of a medicinal product other than the active pharmaceutical ingredient (API) or packaging material. The varying roles of excipients include enhancing dosage form volume or size, the disintegration of solid dosage forms, binding of particulates, lubrication during processing, taste masking, or modifying drug release. The suitability of excipients for their intended use is defined by critical quality attributes (CQAs) such as identity, strength, and purity, while the manufacturing and process development of excipients must meet GMP compliance.
Setting specifications for excipients is complex due to the vast array of materials that are utilized in drug product formulation and is becoming increasingly complicated with the need to update excipient monographs through the introduction of modern analytical techniques.
The United States Pharmacopeia–National Formulary (USP–NF) provides continued guidance on how to specify excipient composition, including control of impurities. However, many believe further efforts are needed from the International Council for Harmonization (ICH) to set guidelines relating to the control of impurities in excipients.
Simplifying the evaluation of pharmaceutical excipients is the main topic of conversation in this on-demand webinar led by industry experts, Dr. Moritz Perscheid, Head of Pharma Services at LGC, and Kieran Evans, Applications Scientist at PerkinElmer. They discuss the numerous challenges associated with detecting impurities in excipients and propose potential strategies for simplifying the process.
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