Evidence map›Paper›PMID 29601840›Full record

ArticleJournal of pharmaceutical sciences2018

Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses.

Neha N Pardeshi, Chen Zhou, Theodore W Randolph, John F Carpenter

Abstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

4 authors.

Neha N PardeshiDepartment of Pharmaceutical Sciences, University of Colorado, Anschutz Medical Campus, Aurora, Colorado 80045.
Chen ZhouDepartment of Pharmaceutical Sciences, University of Colorado, Anschutz Medical Campus, Aurora, Colorado 80045.
Theodore W RandolphDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309.
John F CarpenterDepartment of Pharmaceutical Sciences, University of Colorado, Anschutz Medical Campus, Aurora, Colorado 80045. Electronic address: john.carpenter@ucdenver.edu.

Funding

Biotechnology Research Partnerships Renewal: Aggregation of Therapeutic ProteinsR01EB006006 · NIBIB · UNIVERSITY OF COLORADO · PI RANDOLPH, THEODORE W · 2006 to 2017
$7.2M
NIBIB NIH HHS R01 EB006006
6 · The paper itself

Abstract

In this study, we investigated the potential roles of nanoparticles (<100 nm) and submicron (100-1000 nm) particles in the formation of microparticles (>1000 nm) in protein formulations under some pharmaceutically relevant stress conditions. Exposure of intravenous immunoglobulin solutions to the interface-associated stresses of freeze-thawing or agitation resulted in relatively large increases in microparticle concentrations, which depended directly on the levels of pre-existing nano- and submicron particles. Thus, agglomeration of nanoparticles and submicron particles appears to play a role in microparticle formation under these stresses. In contrast, increases in microparticle concentrations during quiescent incubation at elevated temperatures were independent of the initial nano- and submicron particle concentrations in solution.

Indexed as

Protein AggregatesCentrifugationDrug StabilityFreezingHot TemperatureImmunoglobulins, IntravenousNanoparticlesParticle SizeProtein StabilityStress, MechanicalImmunoglobulins, IntravenousProtein Aggregatesadsorptiondegradation product(s)desorptionformulationmAb(s)microparticle(s)nanoparticle(s)physical stabilityprotein aggregationsurfactant(s)

Identifiers

PMID29601840
PMCPMC6245654

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Registered trials

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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.