Dimethyl Sulfoxide USP, PhEur in Approved Pharmaceutical Products and Medical Devices - Pharmaceutical Technology

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Dimethyl Sulfoxide USP, PhEur in Approved Pharmaceutical Products and Medical Devices
The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.


Pharmaceutical Technology


References

1. J.G Harter, "The Status of Dimethyl Sulfoxide from the Perspective of the Food and Drug Administration," Ann. N.Y. Acad. Sci. 411, 11–13 (1983).

2. L.F. Rubin and K.C. Barnett, "Ocular Effects of Oral and Dermal Applications of Dimethyl Sulfoxide in Animals," Ann. N.Y. Acad. Sci. 141, 333–345 (1967).

3. J.M Fischer, "DMSO: A Review," US Pharmacist 25–32 (Sept.1981).

4. A.M.A. Department of Drugs, Agents Used to Treat Interstitial Cystitis in A.M.A Drug Evaluations (American Medical Association, Chicago, IL 4th ed., 1980), pp. 617–618.

5. R.G. Strickley, "Solubilizing Excipients in Oral and Injectable Formulations," Pharm. Res. 21 (2), 225 (2004).

6. FDA Center for Drug Evaluation and Research, Inactive Ingredient Database, http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm (Sept. 14, 2007), accessed Mar. 14, 2008.

7. Onyx Liquid Embolic System: Instructions for Use (Microtherapeutics Corp., Irvine, CA)

8. R.R. Dmochowski, "Tegress Urethral Implant Phase III Clinical Experience and Product Uniqueness," Rev. Urol. 7 (suppl 1), S22–S26 (2005).

9. E.R. Smith, Z. Hadidian, and M.M. Mason, "The Single and Repeated Dose Toxicity of Dimethyl Sulfoxide," Ann. N.Y. Acad. Sci. 141, 96 (1967).

10. C.F. Brayton, "Dimethyl Sulfoxide (DMSO): A Review," Cornell Vet. 76, 60–90 (1986).

11. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, Jan. 19, 2001), Part 1271.10 (a).

12. Organon Tenika, NucliSens HIV-1Q (Nov. 13, 2001), http://www.fda.gov/cber/pmalabel/P0100010LB.pdf, accessed Mar. 14, 2008.

13. A. Aliago et al., "A Topical Solution of 40% Idoxuridine in Dimethyl Sulfoxide Compared to Oral Acyclovir in the Treatment of Herpes Zoster. A Double-Blind Multicenter Clinical Trial," Med Clin 98 (7), 245 (1992).

14. A. Ely and B. Lockwood "What is the Evidence for the Safety and Efficacy of Dimethyl Sulfoxide and Methylsulfonylmethane in Pain Relief?" The Pharmaceutical Journal 269, 685–687 (2001).

15. Gaylord Chemical, Dimethyl Sulfoxide (DMSO) Solubility Data, (Sept. 2, 2007), http://www.gaylordchemical.com/bulletins/Bulletin102B/index.htm, accessed Mar. 14, 2008.

16. R.C. Rowe, P.J. Sheskey, and S.C. Owen, The Handbook of Pharmaceutical Excipients (Pharmaceutical Press, London, UK, 5th ed., 2006)

17. R.Woodford and B.W. Barry "Penetration Enhancers and the Percutaneous Absorption of Drugs: An Update" J. Toxicol. Cut. Ocular Toxicol. 5 (3), 167–177 (1986).

18. G. Kvakovszky and A.S. McKim, Gaylord Chemical Company LLC, previously unpublished data.

19. USP 28–NF 23 (United States Pharmacopeial Convention, Inc., Rockville, MD, 2005), pp. 662–664.

20. European Pharmacopoeia (Council of Europe, Strasbourg, 2002), p. 1055.

21. ICH, Q3C : Impurities: Residual Solvents, http://www.fda.gov/cder/audiences/iact/ICH_Q3C.htm (Oct. 2007).


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