Pentosan polysulfate sodium capsules contains a mixture of polysulfated xylan as active pharmaceutical ingredient (API). Pentosan polysulfate sodium (PPS) is used to reduce bladder pain or discomfort associated with interstitial cystitis. PPS was originally approved as an orphan drug by FDA in 1996. The API was obtained from extraction of beech wood, followed by a sulfation process. The manufacture of PPS involves depolymerization to achieve a molecular weight of 4-6 kDa. To date, there is no approved generic PPS, likely because of challenges in demonstrating sameness of this complex API in the generic drug product to the API in the RLD.<br/>The emergence of advanced analytical instrumentation with high sensitivity and resolution, enabling methods such as high field 2D NMR, high mass accuracy LC-MS, or MALDI-TOF-MS, has played a key role in deconvolution of some complex drug substances. These techniques may be used to characterize PPS in reference listed drug (RLD) and to establish sameness of generic API to the RLD API.<br/>This presentation will highlight the complex composition and structural features of PPS and concomitant challenges of establishing API sameness with a comparator product. Potential analytical technologies for characterization of PPS to establish API sameness Pentosan Polysulfate Sodium Capsules will be discussed.

Analytical tools for characterization of pentosan polysulfate sodium

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

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