TY - JOUR
T1 - Reproducible, biocompatible medical materials from biologically derived polysaccharides
T2 - Processing and Characterization
AU - Modak, Piyush
AU - Hammond, Willis
AU - Jaffe, Michael
AU - Nadig, Malavika
AU - Russo, Richard
N1 - Funding Information:
The authors thank Dr. Veronica Bracken, Dr. Sam D'Arcangelis, Dr. Benny Freeman, Dr. Tom Gsell and Dr. Zohar Ophir for their insights and expertise that greatly assisted this research. This work was supported by a grant from the National Institute for Neurological Disorders and Stroke (NIH NINDS SBIR R44 NS070331), W. Chen PhD as PI.
Funding Information:
The authors thank Dr. Veronica Bracken, Dr. Sam D'Arcangelis, Dr. Benny Freeman, Dr. Tom Gsell and Dr. Zohar Ophir for their insights and expertise that greatly assisted this research. This work was supported by a grant from the National Institute for Neurological Disorders and Stroke (NIH NINDS SBIR R44 NS070331), W. Chen PhD as PI.
Publisher Copyright:
© 2019 Wiley Periodicals, Inc.
PY - 2020/3/15
Y1 - 2020/3/15
N2 - Natural polysaccharides like chitosan and dextran have garnered considerable interest in biomedical applications due to their biocompatibility, biodegradability, and nontoxicity. Nonetheless, the development of a reproducible class of medical devices from these materials is challenging and has had limited success. Chitosan and dextran are inherently variable and synthesis using these materials is prone to inconsistencies. In this study, we put forward a robust product development regimen that allows these natural materials to be developed into a reproducible class of biomaterials. First, an array of validated characterization methods (Proton Nuclear Magnetic Resonance, titrations, Ultraviolet spectroscopy, Size Exclusion Chromatography—Multi-Angle Light Scattering, Size Exclusion Chromatography—Refractive Index, and proprietary methods) were developed that allowed rigorous specifications to be set for unprocessed chitosan and dextran, chitosan and dextran intermediates, and chemically modified materials—acrylated chitosan (aCHN) and oxidized dextran (oDEX). Second, a robust and reproducible synthesis scheme involving various in-process controls was developed to chemically modify the unprocessed polysaccharides. Third, purification methods to remove byproducts and low-molecular-weight impurities for both aCHN and oDEX were developed. The study presents a viable strategy for converting variable, natural materials into a reproducible class of biomaterials that can be applied in various biomedical applications.
AB - Natural polysaccharides like chitosan and dextran have garnered considerable interest in biomedical applications due to their biocompatibility, biodegradability, and nontoxicity. Nonetheless, the development of a reproducible class of medical devices from these materials is challenging and has had limited success. Chitosan and dextran are inherently variable and synthesis using these materials is prone to inconsistencies. In this study, we put forward a robust product development regimen that allows these natural materials to be developed into a reproducible class of biomaterials. First, an array of validated characterization methods (Proton Nuclear Magnetic Resonance, titrations, Ultraviolet spectroscopy, Size Exclusion Chromatography—Multi-Angle Light Scattering, Size Exclusion Chromatography—Refractive Index, and proprietary methods) were developed that allowed rigorous specifications to be set for unprocessed chitosan and dextran, chitosan and dextran intermediates, and chemically modified materials—acrylated chitosan (aCHN) and oxidized dextran (oDEX). Second, a robust and reproducible synthesis scheme involving various in-process controls was developed to chemically modify the unprocessed polysaccharides. Third, purification methods to remove byproducts and low-molecular-weight impurities for both aCHN and oDEX were developed. The study presents a viable strategy for converting variable, natural materials into a reproducible class of biomaterials that can be applied in various biomedical applications.
KW - chitosan
KW - controlled chemical modifications
KW - dextran
KW - hydrogel devices
KW - medical device
KW - polysaccharides
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U2 - 10.1002/app.48454
DO - 10.1002/app.48454
M3 - Article
AN - SCOPUS:85076329129
SN - 0021-8995
VL - 137
JO - Journal of Applied Polymer Science
JF - Journal of Applied Polymer Science
IS - 11
M1 - 48454
ER -