Evidence map›Paper›PMID 34203672›Full record

ArticlePharmaceutics2021

Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion.

Sandeep Kumar Reddy Adena, Michele Herneisey, Eric Pierce, Paul R Hartmeier, Suneera Adlakha, Marco A I Hosfeld, James K Drennen, Jelena M Janjic

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

8 authors.

Sandeep Kumar Reddy AdenaGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Michele HerneiseyGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Eric PierceGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Paul R HartmeierGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Suneera AdlakhaGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Marco A I HosfeldGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
James K DrennenGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.
Jelena M JanjicGraduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA.

Funding

U.S. Air Force FA8650-20-2-6224U.S. Air Force FA8650-20-C-6215
6 · The paper itself

Abstract

In the presented study, we report development of a stable, scalable, and high-quality curcumin-loaded oil/water (o/w) nanoemulsion manufactured by concentration-mediated catastrophic phase inversion as a low energy nanoemulsification strategy. A design of experiments (DoE) was constructed to determine the effects of process parameters on the mechanical input required to facilitate the transition from the gel phase to the final o/w nanoemulsion and the long-term effects of the process parameters on product quality. A multiple linear regression (MLR) model was constructed to predict nanoemulsion diameter as a function of nanoemulsion processing parameters. The DoE and subsequent MLR model results showed that the manufacturing process with the lowest temperature (25 °C), highest titration rate (9 g/minute), and lowest stir rate (100 rpm) produced the highest quality nanoemulsion. Both scales of CUR-loaded nanoemulsions (100 g and 500 g) were comparable to the drug-free optimal formulation with 148.7 nm and 155.1 nm diameter, 0.22 and 0.25 PDI, and 96.29 ± 0.76% and 95.60 ± 0.88% drug loading for the 100 g and 500 g scales, respectively. Photostability assessments indicated modest loss of drug (<10%) upon UV exposure of 24 h, which is appropriate for intended transdermal applications, with expected reapplication of every 6-8 h.

Indexed as

catastrophic phase inversionmultiple linear regressionnanoemulsionquality by design

Identifiers

PMID34203672
PMCPMC8232217

What OpenQuestion holds

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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.