Journal
MOLECULES
Volume 24, Issue 11, Pages -Publisher
MDPI
DOI: 10.3390/molecules24112066
Keywords
quality by design (QbD); modeling; microemulsions
Funding
- Duquesne University Graduate School of Pharmaceutical Sciences
- Division of Pharmaceutical and Administrative Sciences, School of Pharmacy, Duquesne University
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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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