Excipients safety

Winek, C.L. (2000). History of excipient safety and toxicity. Excipient Toxicity and Safety, (Werner, M.L., and Kotkoskie, L.A., Eds.). Marcel Dekker, New York, pp. 59-72. 

Steinberg M, Kinoshita FK. Excipients—safety testing. In Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. 2nd ed. New York Marcel Dekker, Inc., 2002 1143. 

Winek CL. History of excipient safety and toxicity. In Weiner ML, Kotkoskie LA, eds. Excipient Toxicity and Safety, Drugs and the Pharmaceutical Sciences. Vol. 103. Basel, New York Marcel Dekker, 2000 59. 

One of IPEC s greatest accomplishments has been the development of new excipient safety evaluation guidelines. Previously, there were no generally accepted safety evaluation processes for excipients anywhere in the world. The IPEC guidelines fill this void. 

For biological products (the chemical) excipients are often overlooked. They, too, may have effects or side effects and can leave residues in animals that end up in human food. Their choice for a development product must be considered carefully. Either one uses ingredients with a well established quality and safety profile or one must face the fact that a variety of analytical and safety data have to be established for these excipients. Safety studies for new excipients may cost more than the safety assessment of the biological product itself. 

Progress in drug delivery systems and new proteins/ peptides being developed for parenteral administration has created a need to expand the list of excipients that can be safely used. An informational chapter included in the USP 24, presents a scientifically based approach for safety assessment of new pharmaceutical excipi-ents.f This chapter is based on the excipient safety evaluation guidelines prepared by The Safety Committee of the International Pharmaceutical Excipient Council, with appropriate reaction. Table 14 summarizes the approach in developing a new excipient. 

Excipients Safety Testing, p. 1656. Excipients Parenteral Dosage Eorms and Their Role, p. 1622. 

Summary of excipient safety testing for different routes of exposure for humans (draft proposal being developed by IPEC-Europe and IPEC-America). 

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