Issue link: https://www.e-digitaleditions.com/i/1295512
Tablets & Capsules October 2020 11 E Chris Moreton FinnBrit Consulting Excipient quality: Beyond the pharmacopeia monograph quality Ensuring excipient quality requires extra-monograph testing and specifications, which should be agreed upon between the excipient end user and supplier. This article discusses how application of Quality-by-Design (QbD) principles can help to define such extra-monograph testing and specifications. xcipients are anomalies of pharmaceutical science. They typically do not treat a disease or improve the patient's quality of life, but without them, many of the therapeutic advances of the last 100 years or so would not have happened. Excipients, along with the product manu- facturing process, help convert bulk active pharmaceutical ingredients (APIs) into medicinal products that patients can use, since most APIs administered unformulated would not be acceptable to the patient or caregiver and/ or would not provide the required therapeutic benefit.