Dimethyl sulfoxide USP, PhEur in approved pharmaceutical products and medical devices

Pharmaceutical Technology

Volumn 32, Issue 5, 2008, Pages 74-85

  McKim, A S ^a   Strub, Robert ^b  

^a Gaylord Chemical Company LLC   (United States)

^b Gaylord Chemical Company LLC

Author keywords

[No Author keywords available]

Indexed keywords

BIOCOMPATIBILITY; DRUG PRODUCTS; DRUG THERAPY; HEALTH CARE;

HEALTHCARE INDUSTRY; PHARMACEUTICAL COMPOUNDS;

DIMETHYL SULFOXIDE;

ADHESIVE AGENT; ALCOHOL; CARBOMER; CASTOR OIL; DIMETHYL SULFOXIDE; ETHYL CELLULOSE; EXCIPIENT; HYDROXYMETHYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; LEUPRORELIN; MACROGOL; METHYLCELLULOSE; MINERAL OIL; ORPHAN DRUG; POLOXAMER; POLYGLACTIN; POLYLACTIDE; POLYMETHACRYLIC ACID; POLYVINYL ALCOHOL; POVIDONE; SOLUBILIZER; SOLVENT; SORBITAN; STARCH; STEARIC ACID; SUCROSE; UNINDEXED DRUG; WATER; WHITE PETROLATUM;

ARTICLE; CRYOPRESERVATION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG PENETRATION; DRUG RESEARCH; DRUG SOLUBILITY; FLOW KINETICS; GOOD MANUFACTURING PRACTICE; HUMAN; INTERSTITIAL CYSTITIS; NONHUMAN; SUSTAINED DRUG RELEASE; VISCOSITY;

EID: 44049102287     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

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).
22. P.W. Davis "An Incipient 'Wonder Drug' Movement: DMSO and the Food and Drug Administration," Social Problems 32 (32), 197-212 (1984).
23. L. Murdoch "Dimethyl Sulfoxide - An Overview," Canadian Journal of Hospital Pharmacy, 35 (3), 79-85 (1982).
24. A.M Kligman, "Topical Pharmacology and Toxicology of Dimethyl Sulfoxide (DMSO) Part 1," J. Amer. Med. Assoc. 193, 140-148 (1965)
25. A.M Kligman "Topical Pharmacology and Toxicology of Dimethyl Sulfoxide (DMSO) Part 2," J. Amer. Med. Assoc. 193, 151-156 (1965)
26. R.D. Brobyn, "The Human Toxicology of Dimethyl Sulfoxide," J. Amer. Med. Assoc. 243, 497-506 (1975).
27. "The Riddle of DMSO," Narr. Mike Wallace, Prod. Marion Goldin CBS Television Network, March 23, 1980.
28. M.D. Anderson Cancer Center "Herbal/Plant Therapies: DMSO (Dimethyl Sulfoxide)" http://www.mdanderson.org/departments/cimer/display.cfm?id= 8e9bcb72-f0a0-11d4-810300508b603a14&method=displayfull&pn= 6eb86a59-ebd9-11d4-810100508b603a14 (Sept. 2007), accessed Mar. 14, 2008.
29. B.H Ali, "Dimethyl Sulfoxide: Recent Pharmacological and Toxicological Research," Vet. Human Toxicol. 43 (4) 228-231 (2001).
30. US EPA, "High Production Volume Challenge: Robust Summaries and Test Plans: Dimethyl Sulfoxide" http://www.epa.gov/chemrtk/pubssummaries/ dimthslf/c14721tc.htm (Oct. 16, 2007).
31. T.J. Franz, P.A. Lehman, and M.K. Kagy, "Dimethylsulfoxide," in Percutaneous Penetration Enhancers, E.W. Smith and H.I. Maibach, Eds. (CRC Press, Boca Raton, FL, lsted, 1995), pp. 116-127.
32. C. Ursin et al., "Permeability of Commercial Solvents Through Living Human Skin," Am. Ind. Hyg. Assoc. J. 56, 651-660 (1995).
33. Chemical Effect Information Center, Problem Definition Study of Dimethyl Sulfoxide (DMSO) and Interactive Health Effects with Other Chemicals, Final Report (Oak Ridge National Laboratory, Oak Ridge, TN, 1984), p. 53.