Optimization of a PGSS (particles from gas saturated solutions) process for a fenofibrate lipid-based solid dispersion formulation

International Journal of Pharmaceutics
Aude PestieauBrigitte Evrard

Abstract

The aim of this study was to develop a formulation containing fenofibrate and Gelucire(®) 50/13 (Gattefossé, France) in order to improve the oral bioavailability of the drug. Particles from gas saturated solutions (PGSS) process was chosen for investigation as a manufacturing process for producing a solid dispersion. The PGSS process was optimized according to the in vitro drug dissolution profile obtained using a biphasic dissolution test. Using a design of experiments approach, the effects of nine experimental parameters were investigated using a PGSS apparatus provided by Separex(®) (Champigneulles, France). Within the chosen experimental conditions, the screening results showed that the drug loading level, the autoclave temperature and pressure, the connection temperature and the nozzle diameter had a significant influence on the dissolution profile of fenofibrate. During the optimization step, the three most relevant parameters were optimized using a central composite design, while other factors remained fixed. In this way, we were able to identify the optimal production conditions that would deliver the highest level of fenofibrate in the organic phase at the end of the dissolution test. The closeness between the measured...Continue Reading

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Citations

Feb 7, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Justine ThiryBrigitte Evrard
Jan 31, 2016·Advanced Drug Delivery Reviews·Teófilo VasconcelosBruno Sarmento
Jun 6, 2016·International Journal of Pharmaceutics·Hongjian GengSiling Wang
Jan 25, 2018·International Journal of Molecular Sciences·Botond PenkeLászló Vígh
May 17, 2019·Therapeutic Delivery·Alicia Graciela CidJosé María Bermúdez
Dec 17, 2015·Archives of Pharmacal Research·Pravin Nalawade, Anuradha Gajjar
Jun 25, 2019·Current Medicinal Chemistry·Bruno Fonseca-SantosMarlus Chorilli
Oct 30, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Clara López-IglesiasCarlos A García-González

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