Manufacturing Nanosized Fenofibrate by Salt Assisted Milling

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.

Department(s)

Chemistry

International Standard Serial Number (ISSN)

0724-8741

Document Type

Article - Journal

Document Version

Citation

File Type

text

Language(s)

English

Rights

© 2009 Springer New York, All rights reserved.

Publication Date

01 Jan 2009

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