Review of Current Issues in Pharmaceutical Excipients - Pharmaceutical Technology

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Review of Current Issues in Pharmaceutical Excipients
Excipients facilitate formulation design and perform a wide range of functions to obtain desired properties for the finished drug product. The article reviews excipient development and functionality of these materials, including their importance in formulation design, potential processing challenges directly related to excipients, and therapeutic benefits.

Pharmaceutical Technology


It has been said that formulation is as much science as it is an art. It involves understanding the ingredients and making justifiable selections and adjustments based on the knowledge of the special characteristics of the ingredients and working hard to get the most out of the excipients in the holistic sense. In the end, success stories can be told in many aspects of the drug products from the robust formulation and manufacturing process, to smooth scale up and process validation, to strong regulatory acceptance and market-share domination in their therapeutic areas. Paying attention to pharmaceutical excipients and their regulatory issues is an indispensable initial step to the success of drug products.

Dorothy Chang, MD,* is a resident doctor at Thomas Jefferson University Hospital, 833 Chestnut St., Suite 220, Philadelphia, PA 19107. Rong-Kun Chang, PhD, is associate director at Supernus Pharmaceuticals (Rockville, MD).

*To whom all correspondence should be addressed.
Submitted: Jan. 15, 2007. Accepted: March 9 2007.
Keywords: Excipients, Formulation, USP


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