Evidence map›Paper›PMID 34184149›Full record

ArticleAAPS PharmSciTech2021

Influence of Plasdone

Arun Butreddy, Sandeep Sarabu, Suresh Bandari, Amol Batra, Kamaru Lawal, Nick Ningyi Chen, Vivian Bi, Thomas Durig, Michael A Repka

Open access · greenAbstract read
In one paragraph

Article in AAPS PharmSciTech, 2021. 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
1.2field-weighted citation impact, top 24% 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, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Preparation of Curcumin-EudragitMolecules (Basel, Switzerland) · 2021
    Article
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

9 authors at 2 institutions in 1 country.

Arun ButreddyDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Sandeep SarabuDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Suresh BandariDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA.
Amol BatraAshland Specialty Ingredients, Wilmington, Delaware, 19808, USA.
Kamaru LawalAshland Specialty Ingredients, Wilmington, Delaware, 19808, USA.
Nick Ningyi ChenAshland Specialty Ingredients, Wilmington, Delaware, 19808, USA.
Vivian BiAshland Specialty Ingredients, Wilmington, Delaware, 19808, USA.
Thomas DurigAshland Specialty Ingredients, Wilmington, Delaware, 19808, USA.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, Oxford, Mississippi, 38677, USA. marepka@olemiss.edu.
Ashland (United States) · USUniversity of Mississippi · US

Funding

Pilot Project ProgramP30GM122733 · NIGMS · UNIVERSITY OF MISSISSIPPI · PI WILLETT, KRISTINE L · 2018 to 2022
$5.3M
NIGMS NIH HHS P30 GM122733
6 · The paper itself

Abstract

In a formulation, traces of peroxides in copovidone can impact the stability of drug substances that are prone to oxidation. The present study aimed to investigate the impact of peroxides in novel Plasdone™ S630 Ultra and compare it with regular Plasdone™ S630 on the oxidative degradation of quetiapine fumarate amorphous solid dispersions prepared via hot-melt extrusion technique. The miscibility of copovidones with drug was determined using the Hansen solubility parameter, and the results indicated a miscible drug-polymer system. Melt viscosity as a function of temperature was determined for the drug-polymer physical mixture to identify the suitable hot-melt extrusion processing temperature. The binary drug and polymer (30:70 weight ratio) amorphous solid dispersions were prepared at a processing temperature of 160°C. Differential scanning calorimetry and Fourier transform infrared spectroscopy studies of amorphous solid dispersions revealed the formation of a single-phase amorphous system with intermolecular hydrogen bonding between the drug and polymer. The milled extrudates were compressed into tablets by using extragranular components and evaluated for tabletability. Stability studies of the milled extrudates and tablet formulations were performed to monitor the oxidative degradation impurity (N-oxide). The N-oxide impurity levels in the quetiapine fumarate - Plasdone™ S630 Ultra milled extrudates and tablet formulations were reduced by 2- and 3-folds, respectively, compared to those in quetiapine fumarate - Plasdone™ S630. The reduced oxidative degradation and improved hot-melt extrusion processability of Plasdone™ S630 Ultra make it a better choice for oxidation-labile drugs over Plasdone™ S630 copovidone.

Indexed as

Calorimetry, Differential ScanningChemistry, PharmaceuticalDrug CompoundingHot Melt Extrusion TechnologyHot TemperatureOxidation-ReductionPharmaceutic AidsPovidonePyrrolidinesQuetiapine FumarateSolubilitySpectroscopy, Fourier Transform InfraredVinyl CompoundsPharmaceutic Aidspoly(vinylpyrrolidone-co-vinyl-acetate)PovidonePyrrolidinesQuetiapine FumarateVinyl Compoundsamorphous solid dispersionscopovidoneshot-melt extrusionoxidationperoxides

Identifiers

PMID34184149
PMCPMC8425456
OpenAlexW3175536598

What OpenQuestion holds

Textmetadata
LicenceTDM
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.