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

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 determi...

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Autores principales: Adena, Sandeep Kumar Reddy, Herneisey, Michele, Pierce, Eric, Hartmeier, Paul R., Adlakha, Suneera, Hosfeld, Marco A. I., Drennen, James K., Janjic, Jelena M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8232217/
https://www.ncbi.nlm.nih.gov/pubmed/34203672
http://dx.doi.org/10.3390/pharmaceutics13060880
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author Adena, Sandeep Kumar Reddy
Herneisey, Michele
Pierce, Eric
Hartmeier, Paul R.
Adlakha, Suneera
Hosfeld, Marco A. I.
Drennen, James K.
Janjic, Jelena M.
author_facet Adena, Sandeep Kumar Reddy
Herneisey, Michele
Pierce, Eric
Hartmeier, Paul R.
Adlakha, Suneera
Hosfeld, Marco A. I.
Drennen, James K.
Janjic, Jelena M.
author_sort Adena, Sandeep Kumar Reddy
collection PubMed
description 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.
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spelling pubmed-82322172021-06-26 Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion Adena, Sandeep Kumar Reddy Herneisey, Michele Pierce, Eric Hartmeier, Paul R. Adlakha, Suneera Hosfeld, Marco A. I. Drennen, James K. Janjic, Jelena M. Pharmaceutics Article 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. MDPI 2021-06-15 /pmc/articles/PMC8232217/ /pubmed/34203672 http://dx.doi.org/10.3390/pharmaceutics13060880 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Adena, Sandeep Kumar Reddy
Herneisey, Michele
Pierce, Eric
Hartmeier, Paul R.
Adlakha, Suneera
Hosfeld, Marco A. I.
Drennen, James K.
Janjic, Jelena M.
Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title_full Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title_fullStr Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title_full_unstemmed Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title_short Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion
title_sort quality by design methodology applied to process optimization and scale up of curcumin nanoemulsions produced by catastrophic phase inversion
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8232217/
https://www.ncbi.nlm.nih.gov/pubmed/34203672
http://dx.doi.org/10.3390/pharmaceutics13060880
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