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Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) Grade Product Sheet

The Right DMSO for Drug Delivery Application


Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is the only grade of DMSO suitable for Healthcare and Drug Delivery applications. Gaylord Chemical’s USP grade is the only DMSO that is manufactured under cGMP conditions, in compliance with API guidelines. Supported by a Drug Master File (DMF) on file with the FDA and Health Canada, the product conforms to both the USP and Ph. Eur. Monographs.

Medical bottles and syringe.

Versatile

  • As an Active Pharmaceutical Ingredient (API)
  • Excipient in Drug Delivery Systems to enhance efficacy of therapeutic agents
  • To solubilize active ingredients and polymers in drug delivery and Medical Devices
  • Depot Delivery as an API solvent
  • A Process aid in dosages and devices manufacture
  • Cryopreservation in cell culture, vaccines and drug delivery, also in storage of human umbilical cord blood, hemopoietic stem cells, and biological tissue.

Procipient® Characteristics

API Solubility
Procipient®(Dimethyl Sulfoxide USP, PhEur) provides outstanding solubility for an extensive range of Active Pharmaceutical Ingredients (API). Compatibility for polymers and excipients plus a list of API solubility measurements are available here.

Physical Properties
Procipient, an odorless DMSO, is a clear water-white liquid, of low viscosity (2.0 cP @ 25°C) having a density similar to water (1.0955 g / mL @ 25C). It is completely water miscible. DMSO has the ability to significantly depress the freezing point of water, and the high polarity of DMSO is responsible for its almost universal solvent properties.

Low Toxicity
DMSO is essentially non-toxic by all routes of administration. It is oxidized in the body and resulting metabolic products are excreted in the urine. Its absorption, distribution, metabolism, and elimination (ADME) properties have been studied extensively in both man and animals1.

Procipient® Applications in Healthcare

Pharmaceutical Active
The product RIMSO-50TM contains Dimethyl Sulfoxide USP and is indicated for the symptomatic relief of patients with interstitial cystitis2. The product is instilled directly into the bladder using a catheter or aseptic syringe.

Drug Delivery
DMSO has been described in new technology to produce anhydrous emulsions for the delivery of hydrolytically unstable drugs, or to provide reservoirs for transdermal delivery systems3.

DMSO continues to be evaluated as a penetration enhancer5 in transdermal formulations containing anti-inflammatory , steroidal6 and antiviral drugs7 It has also been formulated as a component of topical anesthetics8. Human skin irritation trials9 have shown that subjects experienced very low levels of skin irritation when subjected to DMSO / ethanol formulations having DMSO present at levels as high as 70%.

In the treatment of wounds, DMSO has been reported as a solvent for sprayable films and dressings used to promote healing of biological tissue10. Additionally, it has been patented as a penetrant in formulations designed to treat skin and mucosal lesions in a topical manner11.

Medical Devices
DMSO has been used to dissolve medical polymers that precipitate in situ to form biodegradable implants12. Such medical devices may be designed to aid in tissue regeneration13, or in the controlled release of active substances14.

Process Aid
Antisolvent methods which use DMSO to disperse a polymer in the formation of microcapsules have been described4.

Cryopreservation
DMSO has been used to preserve a variety of cell types, including human bone marrow15, ovarian tissue16, pancreatic and platelet cells17, and hematopoietic stem and progenitor cells18. DMSO freely permeates the cell and protects intracellular organelles by mixing with water inside the cell. This depresses the freezing point of the medium, thus preventing damage to the cell from ice formation.

References

  1. Kolb, H.K.; Jaenicke, G; Kramer, M.; Schulze, P. Ann. NY Acad. Sci. 141, no.1 (1967) pp. 85-95
  2. Physician’s Desk Reference, 56th edition (2002), p. 1267. b) Stewart, B.; Persky, L.; Kiser,W. J. Urology 98 (1968)pp. 671-672 c) Chancellor, M.; Yoshimura, N. Urology 63 (Supplement 3A) (2004) pp. 85-89. d) RIMSO-50TMis a trademark of Edwards Lifesciences Research Medical, Inc.
  3. Suitthimeathegorn, O.; Jaitely, V.; Florence, A. Drug Delivery Technology 4, no. 5 (2004) pp. 53-56. b)Imhof, A; Pine, D.J. J. Colloid Interface. Sci. 192 (1997), pp. 368-374.
  4. US 5,827,531, assigned to the Administrator of the United States of America.
  5. Franz, T.J.; Lehman, P.A.; Kagy M.K. in Percutaneous Penetration Enhancers, CRC Press, pubs. (1995) pp. 116-127.
  6. Kligman, A.M. JAMA, 193, 10 (1965) pp. 141-149.
  7. Kurihara-Bergstrom, T.; Flynn, G.L.; Higuchi, W.I. J. Invest. Dermatol. 89, (1987) pp.274-280. b) Spruance, S. L;McKeough, M. Antiviral Research, 9 (1988) pp.295-313. c) Spruance, Spotswood, L.; Freeman, D.; Sheth, N.Antimicrobial Agents and Chemotherapy, (1985) p.103-106
  8. Mallory, S.B., Lehmann, P.A.; Vanderpool, D.R.; Franz, T.J. Pediatr. Dermatol. 10, (1993) pp.370-375.
  9. Research performed by DermTech International, 15222 B Avenue of Science San Diego, CA 92128. Testingfunded by Gaylord Chemical Corporation; Results are available upon request.
  10. US 5,792,469, Assigned to Atrix Laboratories, Inc. b) US 5,874,479, Assigned to Warner Lambert Company.
 
  1. US 5,605,684, Assigned to D. Piacquadio.
  2. US 5,733,950, 5,739,176, Assigned to Atrix Laboratories, Inc.
  3. US 5077049, Assigned to Vipont Pharmaceutical, Inc.
  4. US 5,702,716, assigned to Atrix Laboratories, Inc.
  5. Stiff, P.; Murgo, A.; Zaroulis, C.; Derisi, M.; Clarkson, B. Cryobiology, 20 (1983) pp.17-24.
  6. Hovatta, O.; Silya, R.; Krausz, T.; Abir, R.; Margara, R.; Trew, G.; Lass, A. Winston, M. Human Reproduction,11, no.6 (1996) pp.1268-1272.
  7. US 5,827,741, assigned to The Regents of the University of California.
  8. US 5,192,553; US 5,004,681, assigned to the Biocyte Corporation.

The information in this bulletin is based on information available to us and on our observations and experiences. However, no warranty is expressed or implied regarding the accuracy of this data, the results to be obtained from the use thereof, or that any use will not infringe any patent. Each user must establish appropriate procedures for off-loading, handling, and use of the product(s). Since conditions for use are beyond our control, we will make no guarantee of results, and assume no liability for damages incurred by off-loading, handling, or use of the product(s). Nothing herein constitutes permission, or recommendation to practice any invention covered by any patent without license from the owner of the patent.


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