20. October 2016

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...

29. May 2016

Abstract Excipients represent diverse classes of molecules, small molecules or macromolecules, with versatile structures within a given class and are from natural, semi-synthetic and synthetic sources. They are essential ingredients in drug products independently of the route of administration where both traditional and non-traditional uses are present. Beyond their traditional use as formulation and manufacturing aids, certain excipients exhibit biological effects and thus can be used either...