ABSTRACT
The development of innovative pharmaceuticals is critical to improving the health care and standard of living for billions of people around the globe. Bringing novel pharmaceuticals to market requires the expenditure of very significant resources by both drug companies and government regulators. Most of the development efforts and government regulatory expenditures are directed toward the discovery, testing, and oversight of novel pharmaceutical ‘‘active’’ ingredients, as these ingredients are seen as the key to making new drugs available to the world’s population. As a result, the process by which new active ingredients are investigated and regulated is well developed and understood by all parties involved in the process. In contrast, the regulation of pharmaceutical excipients, the ‘‘inactive’’ ingredients used in drug products, presents significant challenges for both government regulators and industry. Historically, excipients were inert substances that were used mainly as fillers, coatings, manufacturing aids, and diluents. Commonly used excipients such as cornstarch, lactose, talc, and sucrose did not present significant questions of safety, and were largely ignored by the regulatory community. Advancements in pharmaceutical technology have rendered this view of excipients as simple inert pharmaceutical fillers obsolete. Pharmaceutical companies and government regulators are slowly developing mechanisms to effectively develop and regulate these pharmaceutical ingredients.
