Evidence map›Paper›PMID 34634661›Full record

ArticleBiomaterials2021

Bioequivalence assessment of high-capacity polymeric micelle nanoformulation of paclitaxel and Abraxane® in rodent and non-human primate models using a stable isotope tracer assay.

Duhyeong Hwang, Natasha Vinod, Sarah L Skoczen, Jacob D Ramsey, Kelsie S Snapp, Stephanie A Montgomery, Mengzhe Wang, Chaemin Lim, Jonathan E Frank, Marina Sokolsky-Papkov and 4 more

Open access · greenAbstract read
In one paragraph

Article in Biomaterials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.1field-weighted citation impact, top 9% 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

18 citing papers in PubMed, 38 citations in OpenAlex.

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  9. Drug delivery for age-related bone diseases: From therapeutic targets to common and emerging therapeutic strategies.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Review
  10. Article
  11. Biological ActivityBiomacromolecules · 2023
    Article
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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

14 authors at 2 institutions in 2 countries.

Duhyeong HwangCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States.
Natasha VinodCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States; Joint UNC/NC State Department of Biomedical Engineering, University of North Carolina, Chapel Hill, NC, 27599, United States.
Sarah L SkoczenNanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory, Frederick, MD, 21702, United States.
Jacob D RamseyCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States.
Kelsie S SnappNanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory, Frederick, MD, 21702, United States.
Stephanie A MontgomeryDepartment of Pathology and Laboratory Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, United States.
Mengzhe WangBiomedical Research Imaging Center, Department of Radiology, and UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27514, United States.
Chaemin LimCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States.
Jonathan E FrankBiomedical Research Imaging Center, Department of Radiology, and UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27514, United States.
Marina Sokolsky-PapkovCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States.
Zibo LiBiomedical Research Imaging Center, Department of Radiology, and UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27514, United States.
Hong YuanBiomedical Research Imaging Center, Department of Radiology, and UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27514, United States.
Stephan T SternNanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory, Frederick, MD, 21702, United States.
Alexander V KabanovCenter for Nanotechnology in Drug Delivery and Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC, 27599, United States; Laboratory of Chemical Design of Bionanomaterials, Faculty of Chemistry, M. V. Lomonosov Moscow State University, Moscow, 119992, Russia. Electronic address: kabanov@email.unc.edu.
University of North Carolina at Chapel Hill · USLeidos (United States) · US

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI PENDLETON, RICHARD · 2019 to 2025
$3932.6M
Small Animal Imaging CoreU54CA198999 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LI, ZIBO · 2015 to 2019
$11.9M
NCI NIH HHS 75N91019D00024NCI NIH HHS U54 CA198999
6 · The paper itself

Abstract

The in vivo fate of nanoformulated drugs is governed by the physicochemical properties of the drug and the functionality of nanocarriers. Nanoformulations such as polymeric micelles, which physically encapsulate poorly soluble drugs, release their payload into the bloodstream during systemic circulation. This results in three distinct fractions of the drug-nanomedicine: encapsulated, protein-bound, and free drug. Having a thorough understanding of the pharmacokinetic (PK) profiles of each fraction is essential to elucidate mechanisms of nanomedicine-driven changes in drug exposure and PK/PD relationships pharmacodynamic activity. Here, we present a comprehensive preclinical assessment of the poly (2-oxazoline)-based polymeric micelle of paclitaxel (PTX) (POXOL hl-PM), including bioequivalence comparison to the clinically approved paclitaxel nanomedicine, Abraxane®. Physicochemical characterization and toxicity analysis of POXOL hl-PM was conducted using standardized protocols by the Nanotechnology Characterization Laboratory (NCL). The bioequivalence of POXOL hl-PM to Abraxane® was evaluated in rats and rhesus macaques using the NCL's established stable isotope tracer ultrafiltration assay (SITUA) to delineate the plasma PK of each PTX fraction. The SITUA study revealed that POXOL hl-PM and Abraxane® had comparable PK profiles not only for total PTX but also for the distinct drug fractions, suggesting bioequivalence in given animal models. The comprehensive preclinical evaluation of POXOL hl-PM in this study showcases a series of widely applicable standardized studies by NCL for assessing nanoformulations prior to clinical investigation.

Indexed as

Antineoplastic Agents, PhytogenicPaclitaxelAlbumin-Bound PaclitaxelAnimalsCell Line, TumorDrug CarriersIsotopesMacaca mulattaMicellesRatsRodentiaTherapeutic EquivalencyAlbumin-Bound PaclitaxelAntineoplastic Agents, PhytogenicDrug CarriersIsotopesMicellesPaclitaxelAbraxane®BioequivalenceNanomedicineNon-human primatePaclitaxelPharmacokineticsPoly(2-oxazoline)sPolymeric micellePreclinical evaluation

Identifiers

PMID34634661
PMCPMC10726948
OpenAlexW3202067994

What OpenQuestion holds

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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.