Excipient safety testing protocol

The safety-toxicological testing of a new excipient for Europe or the United States is as extensive as that for an NCE and can take four to five years to complete. There are differences in the safety evaluation requirements for different types of formulations oral, parenteral and topical/transdermal. The International Pharmaceutical Excipients Council (IPEC Europe and IPEC-Americas) have been working on a protocol for the rational safety testing of excipients to aid the introduction of new chemical excipients (see Table 5.4). IPEC is a federation of three independent regional industry associations based in Europe, the United States and Japan who are focused on the applicable law, regulations and business practices of each region with respect to pharmaceutical excipients. 

The formulations that are developed and used for preclinical studies are sometimes specific for the test species to be employed, but their development always starts with consideration of the route of exposure that is to be used clinically and, if possible, in accordance with a specified regimen of treatment (mirroring the intended clinical protocol, as much as possible). One aspect of both nonclinical and clinical formulation and testing which presents an important but often overlooked aspect of pharmaceutical safety assessment is the special field of excipients. These will be considered at the end of this chapter... 

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