Evidence map›Paper›PMID 32070534›Full record

ArticleCarbohydrate polymers2020

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

Anna Alekseeva, Rahul Raman, Giorgio Eisele, Thomas Clark, Adam Fisher, Sau Larry Lee, Xiaohui Jiang, Giangiacomo Torri, Ram Sasisekharan, Sabrina Bertini

Open access · greenAbstract read
In one paragraph

Article in Carbohydrate polymers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.7field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Anna AlekseevaCentro Alta Tecnologia "Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni" Srl, via G. Colombo 81, 20133 Milan, Italy.
Rahul RamanDepartment of Biological Engineering, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge MA, 02139, United States.
Giorgio EiseleCentro Alta Tecnologia "Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni" Srl, via G. Colombo 81, 20133 Milan, Italy.
Thomas ClarkDepartment of Biological Engineering, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge MA, 02139, United States.
Adam FisherUS Food and Drug Administration, United States.
Sau Larry LeeUS Food and Drug Administration, United States.
Xiaohui JiangUS Food and Drug Administration, United States.
Giangiacomo TorriCentro Alta Tecnologia "Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni" Srl, via G. Colombo 81, 20133 Milan, Italy.
Ram SasisekharanDepartment of Biological Engineering, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge MA, 02139, United States.
Sabrina BertiniIstituto di Ricerche Chimiche e Biochimiche G. Ronzoni, via G. Colombo 81, 20133 Milan, Italy. Electronic address: bertini@ronzoni.it.
Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni · ITMassachusetts Institute of Technology · USUnited States Food and Drug Administration · US

Funding

Integrated approach to determine equivalence in complex drug mixturesU01FD005291 · FDA · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI SASISEKHARAN, RAM · 2014 to 2016
$1.0M
FDA HHS U01 FD005291
6 · The paper itself

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.

Indexed as

Carbohydrate ConformationChromatography, GelCystitis, InterstitialHumansMagnetic Resonance SpectroscopyMolecular WeightPentosan Sulfuric PolyesterSpectrometry, Mass, Electrospray IonizationPentosan Sulfuric PolyesterLC–MSmolecular weight distributionNMRpentosane polysulfatestructural elucidationsulfated polysaccharide

Identifiers

PMID32070534
PMCPMC7171972
OpenAlexW3001627634

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.