Novel excipients – from concept to Launch – Chemistry Today – October 2013
FELICITAS GUTH*, HEIKO A. SCHIFFTER, KARL KOLTER
*Corresponding author BASF SE, Formulation Nutrition & Health, Carl Bosch Str. 38, 67056 Ludwigshafen, Germany
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.
