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In-depth structural characterization of pentosan polysulfate sodium complex drug using orthogonal analytical tools.

Carbohydrate polymers (2020-02-20)
Anna Alekseeva, Rahul Raman, Giorgio Eisele, Thomas Clark, Adam Fisher, Sau Larry Lee, Xiaohui Jiang, Giangiacomo Torri, Ram Sasisekharan, Sabrina Bertini
ABSTRACT

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.

MATERIALS
Product Number
Brand
Product Description

Millipore
MF-Millipore® Membrane Filter, 0.22 µm pore size, 47 mm diameter, mixed cellulose esters (MCE) membrane, hydrophilic, white, 100 discs
Sigma-Aldrich
Dibutylamine, ≥99.5%
Sigma-Aldrich
3-(1-Pyridinio)-1-propanesulfonate, ≥97.0% (N)
Sigma-Aldrich
Acetic acid-12C2, 99.9 atom % 12C