Evidence map›Paper›PMID 32653597›Full record

ArticleInternational journal of pharmaceutics2020

Extended release pellets prepared by hot melt extrusion technique for abuse deterrent potential: Category-1 in-vitro evaluation.

Arun Butreddy, Sandeep Sarabu, Nagireddy Dumpa, Suresh Bandari, Michael A Repka

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.5field-weighted citation impact, top 5% 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

7 citing papers in PubMed, 28 citations in OpenAlex.

  1. Multidimensional opioid abuse deterrence using a nanoparticle-polymer hybrid formulation.Journal of controlled release : official journal of the Controlled Release Society · 2024
    Article
  2. Review
  3. Article
  4. Article
  5. Influence of PlasdoneAAPS PharmSciTech · 2021
    Article
  6. Review
  7. Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective on product development.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2021
    Review
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

5 authors at 1 institution in 1 country.

Arun ButreddyDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Sandeep SarabuDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Nagireddy DumpaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Suresh BandariDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Michael A RepkaDepartment of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS 38677, USA. Electronic address: marepka@olemiss.edu.
University 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

The objective of the present study was to develop extended-release (ER) hot-melt extruded (HME) abuse-deterrent pellets of acetaminophen, a model drug, by utilizing high molecular weight polyethylene oxide (PEO) and gelling agents (xanthan gum, guar gum, and gellan gum). The HME pellets were evaluated for their abuse-deterrence (AD) potential by Category-1 laboratory in-vitro evaluation parameters, including particle size reduction (PSR), small volume extraction, dissolution, viscosity, syringeability, and injectability. Further, the pellets were investigated for resistance to physical (crushing) and thermal (oven and microwave) manipulation to evaluate the strength of the AD properties. Physical manipulation studies demonstrated that the pellets were intact, extremely hard, and resistant to PSR and manipulation to bypass ER properties. Dissolution of all intact and physically manipulated pellets led to complete drug release within 8 h, and resistance to dose-dumping in 40% ethanol was observed. The drug extraction was <50% in 10 mL of ingestible and non-ingestible solvents under static, agitation, and thermal manipulation conditions with an incubation time of 30 min. The PEO/xanthan gum-based formulation showed higher viscosity, syringe and injection forces, and lower syringeable volume in all manipulation conditions compared with plain PEO pellets. These findings supported the AD potential of PEO and xanthan gum pellets against intravenous abuse.

Indexed as

Hot Melt Extrusion TechnologyPolyethylene GlycolsDelayed-Action PreparationsDrug CompoundingDrug ImplantsDrug LiberationSolubilityViscosityDelayed-Action PreparationsDrug ImplantsPolyethylene GlycolsAbuse-deterrent formulationGelling agentHot melt extrusionPhysical and thermal manipulationPolyethylene oxideSyringeability and Injectability

Identifiers

PMID32653597
PMCPMC7484191
OpenAlexW3041694776

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.