Review of Current Issues in Pharmaceutical Excipients - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

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


1. M. Ash and I. Ash, Handbook of Pharmaceutical Additives (Gower Publishing Limited, Hampshire, England, 1995).

2. Handbook of Pharmaceutical Excipients, R. Rowe, P.J. Sheskey, and P. J. Weller, Eds. (Pharmaceutical Press and American Pharmaceutical Association, Chicago, IL, 2003).

3. International Pharmaceutical Excipients Council-Americas, "What are Pharmaceutical Excipients?"

4. Center for Drug Evaluation and Research (CDER), "Inactive Ingredient Search for Approved Drug Products,"

5. CDER, Quality Systems Approach to Pharmaceutical Good Manufacturing Practices, Draft Guidance (Rockville, MD, 2004).

6. S.U. Ahmed, V.Naini, and S.R. Vaithiyalingam, "Physicochemical Characteristics of Drugs and Excipients: An Overview," Amer. Pharm. Rev. 9 (3), 47 –52 (2006).

7. J.R. Johanson, "Defining the Physical Functionality of Excipients, Bulk Drugs and Formulations," Innovations in Pharmaceutical Technology 1 (2), 136–146 (1999).

8. D. Bugay and W.P. Findlay, Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy (Marcel Dekker, Inc., New York, NY, 1999).

9. B.D. Rege et al., "Effect of Common Excipients on Caco-2 Transport of Low-Permeability Drugs," J. Pharm. Sci. 90 (11), 1776–1786 (2001).

10. P.D. Ward, T.K. Tippin, and D.R. Thakker, "Enhancing Paracellular Permeability by Modulating Epithelial Tight Junctions," PSST 3, (10), 348–358 (2000).

11. R. Chang and P. Bhatt, "Recent Trends in Oral Drug Delivery," AAPS Newsmagazine, 18–21 (March 2005).

12. "Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems," A. Katdare and M. Chaubal, Eds. (Informa Healthcare USA, New York, NY, July 2006).

13. J.M. Smith and T.R. Dodd, "Adverse Reactions to Pharmaceutical Excipients," Adv. Drug React. Ac. Pois. Rev. 1, 93–142 (1982).

14. Excipient Toxicity and Safety, W. Kotkoski, M. Weiner, L. Kotkoskie, Eds. (Marcel Dekker, New York, NY, 1999).

15. K. Jackson, D. Young, and S. Pant, "Drug–Excipient Interactions and Their Affect on Absorption," PSTT 3 (10), 338–345 (2000).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here