ArticleMolecules (Basel, Switzerland)2019
Quality by Design Approach Using Multiple Linear and Logistic Regression Modeling Enables Microemulsion Scale Up.
Article in Molecules (Basel, Switzerland), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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The trial behind it
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Who cites it
7 citing papers in PubMed.
- Injectable Thermoresponsive Dual Nanocarrier Hydrogel for Local Tacrolimus Delivery with a Two-Phase Release Profile.Pharmaceutics · 2026Article
- Design of Experiments Leads to Scalable Analgesic Near-Infrared Fluorescent Coconut Nanoemulsions.Pharmaceutics · 2025Article
- Quality by Design (QbD)-Driven Development and Optimization of Tacrolimus-Loaded Microemulsion for the Treatment of Skin Inflammation.Pharmaceutics · 2024Article
- Microemulsions: An Encapsulation Strategy to Increase the Thermal Stability of D-limonene.Pharmaceutics · 2023Article
- Multiple Linear Regression Predictive Modeling of Colloidal and Fluorescence Stability of Theranostic Perfluorocarbon Nanoemulsions.Pharmaceutics · 2023Article
- Quality by Design Methodology Applied to Process Optimization and Scale up of Curcumin Nanoemulsions Produced by Catastrophic Phase Inversion.Pharmaceutics · 2021Article
- Quality by design approach identifies critical parameters driving oxygen delivery performance in vitro for perfluorocarbon based artificial oxygen carriers.Scientific reports · 2021Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
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.
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Registered trials
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