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Open AccessFeature PaperArticle

Quality by Design Approach Using Multiple Linear and Logistic Regression Modeling Enables Microemulsion Scale Up

1
Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15228, USA
2
Chronic Pain Research Consortium, Duquesne University, Pittsburgh, PA 15228, USA
*
Author to whom correspondence should be addressed.
Molecules 2019, 24(11), 2066; https://doi.org/10.3390/molecules24112066
Received: 1 May 2019 / Revised: 24 May 2019 / Accepted: 29 May 2019 / Published: 30 May 2019
(This article belongs to the Special Issue Targeted and Personalized Nanomedicines)
The development of pharmaceutical nanoformulations has accelerated over the past decade. However, the nano-sized drug carriers continue to meet substantial regulatory and clinical translation challenges. In order to address some of these key challenges in early development, we adopted a quality by design approach to develop robust predictive mathematical models for microemulsion formulation, manufacturing, and scale-up. The presented approach combined risk management, design of experiments, multiple linear regression (MLR), and logistic regression to identify a design space in which microemulsion colloidal properties were dependent solely upon microemulsion composition, thus facilitating scale-up operations. Developed MLR models predicted microemulsion diameter, polydispersity index (PDI), and diameter change over 30 days storage, while logistic regression models predicted the probability of a microemulsion passing quality control testing. A stable microemulsion formulation was identified and successfully scaled up tenfold to 1L without impacting droplet diameter, PDI, or stability. View Full-Text
Keywords: quality by design (QbD); modeling; microemulsions quality by design (QbD); modeling; microemulsions
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MDPI and ACS Style

Herneisey, M.; Lambert, E.; Kachel, A.; Shychuck, E.; Drennen, J.K., III; Janjic, J.M. Quality by Design Approach Using Multiple Linear and Logistic Regression Modeling Enables Microemulsion Scale Up. Molecules 2019, 24, 2066.

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