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Novel excipients – fromconcept to launch

FELICITAS GUTH*,HEIKO A. SCHIFFTER, KARL KOLTER
*Corresponding authorBASF SE, Formulation Nutrition & Health, Carl Bosch Str. 38, 67056 Ludwigshafen, Germany

Abstract

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.


INTRODUCTION

Pharmaceutical excipients are the inactive ingredients of a drug product. They are a very heterogeneous group of materials and differ in their origin, chemistry, physicochemical properties and functionality. Most commonly used excipients are sugars, starches or modified starches, minerals, cellulose and its derivatives, fats and oils or solvents. All these materials have a long history of use in pharmaceuticals, food and cosmetic applications. With the transition from simple formulations to drug delivery systems the demand for synthetic or semi-synthetic functional polymers (acrylates, ethoxylated compounds or polyvinylpyrrolidone grades) has increased tremendously (1). Today, as the pharmaceutical industry has to deal with the patent cliff, reduced