期刊
BIORESEARCH OPEN ACCESS
卷 4, 期 1, 页码 218-228出版社
MARY ANN LIEBERT, INC
DOI: 10.1089/biores.2014.0030
关键词
drug development technologies; drug discovery; inflammation
资金
- Microfluidics Corporation (Westwood, MA) [M-110EH-30]
- Duquesne University Start-up Research Funds
- Chronic Pain Research Consortium (CPRC) - Provost's Interdisciplinary Research Consortia Grant at Duquesne University
Theranostic nanomedicines are a promising new technological advancement toward personalized medicine. Although much progress has been made in pre-clinical studies, their clinical utilization is still under development. A key ingredient for successful theranostic clinical translation is pharmaceutical process design for production on a sufficient scale for clinical testing. In this study, we report, for the first time, a successful scale-up of a model theranostic nanoemulsion. Celecoxib-loaded near-infrared-labeled perfluorocarbon nanoemulsion was produced on three levels of scale (small at 54 mL, medium at 270 mL, and large at 1,000 mL) using microfluidization. The average size and polydispersity were not affected by the equipment used or production scale. The overall nanoemulsion stability was maintained for 90 days upon storage and was not impacted by nanoemulsion production scale or composition. Cell-based evaluations show comparable results for all nanoemulsions with no significant impact of nanoemulsion scale on cell toxicity and their pharmacological effects. This report serves as the first example of a successful scale-up of a theranostic nanoemulsion and a model for future studies on theranostic nanomedicine production and development.
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