Ethyl Lactate as a Pharmaceutical-Grade Excipient and Development of a Sensitive Peroxide Assay - Pharmaceutical Technology

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Ethyl Lactate as a Pharmaceutical-Grade Excipient and Development of a Sensitive Peroxide Assay
The authors investigate whether the addition of an antioxidant could be used to stabilize the solvent ethyl lactate by preventing the formation of peroxides.

Pharmaceutical Technology
Volume 33, Issue 5, pp. 74-84


Pharmaceutical-grade, purified ethyl lactate showed extended stability when AA or BHT were used as antioxidants. ELPG is an attractive solubilizing agent because of its low cost, low toxicity, environmentally sound nature, and its derivation from renewable resource. Stabilized ethyl lactate has potential in various pharmaceutical applications such as tablet coating, granulation, taste-masking, and inhalation propellants. Additionally, it may improve the solubility of many active pharmaceutical agents during processing.

Jason T. McConville* is an assistant professor and Thiago C. Carvalho is a graduate student and PhD candidate at the College of Pharmacy, Division of Pharmaceutics, University of Texas at Austin, Austin, TX 78712–0231, tel. 512.471.0942,
. Shawn A. Kucera is a senior applications scientist at Evonik–Degussa Corporation, and Elizabeth Garza is an MD student at the Pritzker School of Medicine, University of Chicago.

*To whom all correspondence should be addressed.

Submitted: June 10, 2008. Accepted: Aug. 12, 2008.

What would you do differently? Submit your comments about this paper in the space below.


1. "Organic Solvent Neurotoxicity" in Current Intelligence Bulletin (National Institute for Occupational Safety and Health, Atlanta, GA), No. 48, 1987.

2. J.T. McConville et al., "The Use Of Antioxidants to Stabilize Ethyl Lactate," presented at the Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists, Baltimore, MD, Nov. 2004.

3. N. Asthana et al., "A Continuous Reactive Separation Process for Ethyl Lactate Formation," Org. Process Res. Dev. 9 (5), 599–607 (2005).

4. R.A. Sheldon, "Green Solvents for Sustainable Organic Synthesis: State of the Art," Green Chemistry 7 (5), 267–278 (2005).

5. J.J. Jafar, P.M. Budd, and R. Hughes, "Enhancement of Esterification Reaction Yield Using Zeolite—A Vapor Permeation Membrane," J. Membr. Sci. 199 (1–2), 117–123 (2002).

6. "Ethyl Lactate—Overview" in Solvent Alternatives Guide,, accessed Apr. 15, 2009.

7. M. Henneberry, "Green Solvents: Agrochemicals in Place of Petrochemicals," Paints & Coatings Industry,, accessed Apr. 15, 2009.

8. "Food and Drug Administration Department of Health and Human Services," in the Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), 2005.

9. Material Safety Data Sheet for Ethyl-(S)-Lactate, Purac America, (Lincolnshire, IL), 2005.

10. N.M. Nikolaeva and M.K. Gluzman, "Conditions for Stabilizing Ethyl Oleate During Storage," Farmatsiya 26 (1), 25–28 (1977).

11. J.M.K. Gluzman and N.M. Nikolaeva, "Method of Obtaining Ethyl Oleate, A Solvent for Parenteral Administration," Farm. Zh. 27 (6), 57–61 (1972).

12. M.A. Memon et al., "Spectrophotometric Determination of Ascorbic Acid in Pharmaceuticals by Flow Injection Analysis Using Brown Mono 1,10–Phenanthroline-Iron (III) Complex as an Oxidant," Med. J . Islamic Acad. Sci. 13 (2), 69–74 (2000).


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