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Molecular Weight Analyses and Enzymatic Degradation Profiles of the Soft-Tissue Fillers Belotero Balance, Restylane, and Juvéderm Ultra

Flynn, Timothy Corcoran M.D.; Thompson, David H. Ph.D.; Hyun, Seok-Hee Ph.D.

doi: 10.1097/PRS.0b013e31829e88a3
Cosmetic: Original Articles

Background: In this study, the authors sought to determine the molecular weight distribution of three hyaluronic acids—Belotero Balance, Restylane, and Juvéderm Ultra—and their rates of degradation following exposure to hyaluronidase. Lot consistency of Belotero Balance also was analyzed.

Methods: Three lots of Belotero Balance were analyzed using liquid chromatography techniques. The product was found to have high-molecular-weight and low-molecular-weight species. One lot of Belotero Balance was compared to one lot each of Juvéderm Ultra and Restylane. Molecular weights of the species were analyzed. The hyaluronic acids were exposed to ovine testicular hyaluronidase at six time points—baseline and 0.5, 1, 2, 6, and 24 hours—to determine degradation rates.

Results: Belotero Balance lots were remarkably consistent. Belotero Balance had the largest high-molecular-weight species, followed by Juvéderm Ultra and Restylane (p < 0.001). Low-molecular-weight differences among all three hyaluronic acids were not statistically significant. Percentages of high-molecular-weight polymer differ among the three materials, with Belotero Balance having the highest fraction of high-molecular-weight polymer. Degradation of the high-molecular-weight species over time showed different molecular weights of the high-molecular-weight fraction. Rates of degradation of the hyaluronic acids following exposure to ovine testicular hyaluronidase were similar. All hyaluronic acids were fully degraded at 24 hours.

Conclusions: Fractions of high-molecular-weight polymer differ across the hyaluronic acids tested. The low-molecular-weight differences are not statistically significant. The high-molecular-weight products have different molecular weights at the 0.5- and 2-hour time points when exposed to ovine testicular hyaluronidase and are not statistically different at 24 hours.

Cary and Chapel Hill, N.C.; and West Lafayette, Ind.

From the Cary Skin Center; the Department of Dermatology, University of North Carolina at Chapel Hill; the Department of Chemistry, Purdue University; and Pandion Laboratories, LLC.

Received for publication April 23, 2013; accepted May 7, 2013.

Disclosure: Dr. Flynn is a consultant for Merz and Canfield Scientific; he has received research support from Merz. Dr. Thompson is a National Institutes of Health–supported organic materials chemist who has several research projects involving hyaluronic acid. He is also president and chief scientific officer of Pandion Laboratories, LLC. Dr. Hyun is a senior research scientist for Pandion Laboratories, which has received research support from Merz. The authors were assisted in development of this manuscript by David J. Howell, Ph.D. (San Francisco). Dr. Howell was compensated by Merz for his editorial assistance.

Timothy Corcoran Flynn, M.D., Cary Skin Center, 200 Wellesley Trade Lane, Cary, N.C. 27519, flynn@caryskincenter.com

©2013American Society of Plastic Surgeons