Novel excipients - from concept to launch

New excipients can improve the quality of drug products and are needed for the development of innovative drug delivery systems. Even though in recent years, a number of new modified or co-processed excipients have been introduced in the market, almost all manufacturers refrain from the development of novel excipients, since it takes time, requires resources and is associated with a certain risk of failure. This article gives an overview of the types of new excipients and explains why the development of a novel excipient is particularly challenging. In addition, the regulatory framework for the approval of new excipients creates a dilemma for the manufacturers and users of novel ingredients.