Dual Use Excipients

What is a “Dual Use Excipient”? 

  • A substance that has a monograph in the USP but is manufactured and used predominantly as an excipient in a drug formulation
  • Many of these may also be used as an “Active” in formulations or in applications that are  associated with ‘higher’ GMP expectations, e.g. parenterals and ophthalmics
  • In some cases it is the only ingredient
  • Another term is “Atypical Active”
  • Not limited to excipients!  It may also be a food additive, a GRAS substance, a personal  care ingredient or even an industrial product

 

Download
Dual Use Excipients
Presentation by
Priscilla Zawislak - Chair, IPEC-Americas
USP Excipients Stakeholder Forum - September 29, 2016
3a-dual-active-excipients-industry-overv
Adobe Acrobat Document 1.1 MB