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Evaluation of Hylan B (Hylan Gel) as Soft Tissue Dermal Implants

Published online by Cambridge University Press:  21 February 2011

N.E. Larsen ,
E. Leshchiner ,
C.T. Pollak  and
E.A. Balazs
N.E. Larsen
Affiliation:
Biomatrix Inc., Ridgefield NJ Piacquadio, D. UCSD Medical Center, San Diego, CA
E. Leshchiner
Affiliation:
Biomatrix Inc., Ridgefield NJ Piacquadio, D. UCSD Medical Center, San Diego, CA
C.T. Pollak
Affiliation:
Biomatrix Inc., Ridgefield NJ Piacquadio, D. UCSD Medical Center, San Diego, CA
E.A. Balazs
Affiliation:
Biomatrix Inc., Ridgefield NJ Piacquadio, D. UCSD Medical Center, San Diego, CA
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Abstract

Hylan B gel is a viscoelastic insoluble crosslinked derivative of the natural hyaluronan (hyaluronic acid, HA) polymer. Hyaluronan derivatives such as hylan B have enhanced rheological properties and possess the desired biological properties of natural hyaluronan. Hylan B was evaluated in nonclinical in vivo studies for biocompatibility and residence times in dermal tissues. In one study, residence time of radiolabeled [14C]-hylan B was evaluated in guinea pigs following intradermal administration with serial sacrifice (0, 1, 4, 12, 24 weeks). Analysis of radioactivity revealed that at 6 months post-implantation up to 98% of the radioactivity was recovered from the specific injection site (mean 76.7± 29.4%). A half-life time of 12.2 months was estimated from analysis of the data. In another study, the behavior of hylan B gel implanted in the intradermal and subcutaneous tissue of guinea pigs was evaluated at 3 days and at 1, 2, 4, 9, 13, 26 and 52 weeks. In this study, collagen implants were evaluated in parallel with hylan B gel implants in the same animals. Hylan B gel was found to be biologically compatible and stable in the dermal tissue. At one year post-implantation, hylan B gel was detected in a majority (12/16) of test sites. None of the collagen implant materials was detected at one year post-implantation.

Type
Research Article
Information
MRS Online Proceedings Library (OPL) , Volume 394: Symposium Z – Polymers in Medicine and Pharmacy , 1995 , 193
Copyright
Copyright © Materials Research Society 1995

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