Quality by design approach using multiple linear and logistic regression modeling enables microemulsion scale up
DOI
10.3390/molecules24112066
Document Type
Journal Article
Publication Date
5-30-2019
Publication Title
Molecules
Volume
24
Issue
11
Keywords
Microemulsions, Modeling, Quality by design (QbD)
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.
Open Access
Gold
Repository Citation
Herneisey, M., Lambert, E., Kachel, A., Shychuck, E., Drennen, J., & Janjic, J. (2019). Quality by design approach using multiple linear and logistic regression modeling enables microemulsion scale up. Molecules, 24 (11). https://doi.org/10.3390/molecules24112066