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Manufacturing Nanosized Fenofibrate by Salt Assisted Milling

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Abstract

Purpose

The aim of this study is to develop a new process for manufacturing a nano-sized form of the popular cholesterol-reducing drug fenofibrate which can be implemented on industrial scale with minimal changes of currently used production schemes.

Methods

Salt-assisted milling was used to reduce particle size of commercial fenofibrate from micron-sized particles to nanometer domains.

Results

The optimal parameters for the salt milling are reported, allowing one to reduce the particle size from tens of micrometers to a hundred of nanometers. Dissolution of nano-sized fenofibrate was studied in various formulations and compared against the micron-sized commercially available fenofibrate.

Conclusions

The nano-sized fenofibrate demonstrates faster dissolution kinetics in aqueous media, simulating stomach environment, within the first 60 min as compared to the micronized form. The highest dissolution rate is achieved with the nano-sized fenofibrate when surfactants, such as sodium dodecyl sulfate or inclusion complex forming agents such as alpha-cyclodextrin, are used.

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Acknowledgements

This project was conducted under NSF grant CMMI-0556082. SEM and XRD were operated by the Centralized Research Facility of the College of Engineering, Drexel University. The authors wish to thank iCeutica Inc., Dr. Matt Callahan, Dr. Raff Cammarano, and Dr. Felix Meiser for useful technical discussions and recommendations during the manuscript preparation.

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Authors and Affiliations

  1. A. J. Drexel Nanotechnology Institute and Department of Materials Science and Engineering, Drexel University, Philadelphia, Pennsylvania, 19104, USA

    Vadym N. Mochalin, Adarsh Sagar & Yury Gogotsi

  2. School of Biomedical Engineering, Drexel University, Philadelphia, Pennsylvania, 19104, USA

    Shruti Gour

Authors
  1. Vadym N. Mochalin
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  2. Adarsh Sagar
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  3. Shruti Gour
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  4. Yury Gogotsi
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Correspondence to Yury Gogotsi.

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Mochalin, V.N., Sagar, A., Gour, S. et al. Manufacturing Nanosized Fenofibrate by Salt Assisted Milling. Pharm Res 26, 1365–1370 (2009). https://doi.org/10.1007/s11095-009-9846-x

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  • DOI: https://doi.org/10.1007/s11095-009-9846-x

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