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Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.
Priscilla Zawislak, Chair, IPEC-Americas, tells Pharmaceutical Technology how the role of excipients has evolved over the years and how the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) has assisted in developing advancements in the industry.
PharmTech: Since IPEC-Americas was founded in 1991, how has the pharmaceutical industry evolved and what advances have been made?
Zawislak (IPEC): Twenty-six years ago, excipients were not the focus of the pharmaceutical industry. Not much thought was given to these ‘inactives’ being functional and impacting the performance of the finished drug product. Today, there are more dosage forms, combination products, and emerging technologies in drug development and manufacturer, all of which excipients have a key role in.
PharmTech: How have regulations and standards changed?
Zawislak (IPEC): In the past, excipients were rarely distinguished from APIs or finished drugs in regulations. Today, excipients are a top priority among regulatory agencies. GMPs and risk assessment for excipients are now the subject of global regulations. Third-party excipient GMP certification is growing as a means to facilitate supplier qualification. Excipient composition and harmonization of monographs are getting increased attention. There are still opportunities, in many countries to continue to bring focus on excipients and distinguishing them from APIs.
PharmTech: What do you foresee for the next 10 years in pharma innovations, regulations, and/or markets?
Zawislak (IPEC): Emerging technologies for drug development, combination products, biopharma, and novel excipients [will be developed]. Regulations will need to keep pace with these.
PharmTech: How has your organization changed since it was first founded?
Zawislak (IPEC): IPEC grew from one US-based trade association to a global federation representing five regions (the United States, Europe, Japan, China, and India). IPEC-Americas went from 12 companies to almost 100 members today. We continue to reach out globally via partnerships with other associations (e.g., Latin America and Canada). We’ve issued 16 guidelines as well as several position papers for the makers and users community. We are now the ‘go-to’ organization for anything related to excipients.
PharmTech: How has your organization influenced the pharma industry?
Zawislak (IPEC): Our guidelines have become the standards in the industry. We have been instrumental in assisting pharmacopeias globally with the standards-setting process and monograph harmonization. We’ve worked closely with FDA and other countries’ agencies on topics related to excipients.
PharmTech: How is your organization planning to grow and affect the industry in the next 10 years?
Zawislak (IPEC): We are exploring additional global expansion and expansion into markets such as biopharma, medical devices, veterinary drugs, etc.
Vol. 41, No. 7
When referring to this article, please cite it as PharmTech, “Perspective: Focus on Excipients,” Pharmaceutical Technology 41 (7) 2017.