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In-depth structural characterization of pentosan polysulfate sodium complex drug using orthogonal analytical tools
Name
nihms-1556241.pdf
Description
Accepted version
Size
897.89 KB
Format
Adobe PDF
Checksum (MD5)
2c7ad22ec8e9ad108277b8d34ee958a2
Author(s)
Alekseeva, Anna
Raman, Rahul
Eisele, Giorgio
Clark, Thomas
Fisher, Adam
Lee, Sau Larry
Jiang, Xiaohui
Torri, Giangiacomo
Sasisekharan, Ram
Bertini, Sabrina
Date Issued
2020
Journal
Carbohydrate Polymers
Publisher
Elsevier BV
Version
Author's final manuscript
Abstract
© 2020 Rapid advances have been made in developing analytical technologies for characterization of highly heterogeneous active ingredients of complex drugs, such as pentosan polysulfate (PPS), active ingredient of the drug Elmiron®, approved by the Food and Drug Administration and marketed in the United States to treat interstitial cystitis. PPS sulfated polysaccharides comprise of a repeat unit of β(1–4)‐D‐xylopyranoses randomly substituted by 4‐O-methyl-glucopyranosyluronic acid. To define the critical quality attributes (CQAs) of such a complex drug, it is critical to develop an approach that integrates data from orthogonal analytical methodologies. Here, we developed an approach integrating diverse analytical tools including gel permeation chromatography, LC/ESI-MS and NMR to measure CQAs of PPS. The proposed mathematical framework integrates the data from these diverse analytical methods as function of PPS chain length and building blocks. Our approach would facilitate in establishing a scientific foundation for comparative characterization of drug products with complex active ingredients.
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Creative Commons Attribution-NonCommercial-NoDerivs License
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DOI of Published Version
10.1016/J.CARBPOL.2020.115913
