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The First Scale-Up Production of Theranostic Nanoemulsions
Lu Liu1, Christina Bagia1, Jelena M Janjic2
1Graduate School of Pharmaceutical Sciences, Mylan School of Pharmacy, Duquesne University , Pittsburgh, Pennsylvania.
Bioresearch Open Access
|August 27, 2015
Summary
This study successfully scaled up a theranostic nanoemulsion for personalized medicine. The production scale did not impact nanoemulsion quality, stability, or therapeutic efficacy, paving the way for clinical translation.
Area of Science:
- Nanomedicine
- Pharmaceutical Sciences
- Personalized Medicine
Background:
- Theranostic nanomedicines offer personalized treatment but face challenges in clinical translation due to production scale limitations.
- Successful clinical utilization requires robust pharmaceutical process design for large-scale production.
Purpose of the Study:
- To report the first successful scale-up of a model theranostic nanoemulsion.
- To evaluate the impact of production scale on nanoemulsion characteristics, stability, and biological effects.
Main Methods:
- Microfluidization was used to produce a celecoxib-loaded, near-infrared-labeled perfluorocarbon nanoemulsion at three scales (54 mL, 270 mL, 1,000 mL).
- Nanoemulsion size, polydispersity, stability (90 days), cell toxicity, and pharmacological effects were assessed across scales.
Main Results:
- Nanoemulsion production scale did not affect average size or polydispersity.
- Nanoemulsion stability was maintained for 90 days, irrespective of scale or composition.
- Cell-based evaluations demonstrated comparable toxicity and pharmacological effects across all scales.
Conclusions:
- This study demonstrates a successful scale-up of theranostic nanoemulsions, overcoming a key hurdle for clinical translation.
- The findings provide a model for future development and large-scale production of nanomedicines for personalized medicine.
