Ibuprofen-loaded calcium stearate pellets: drying-induced variations in dosage form properties.

AAPS PharmSciTech
Simone SchrankE Roblegg

Abstract

Pellets intended for oral dosing are frequently produced via extrusion/spheronization followed by drying. Typically, the last active process step, i.e., drying, is assumed to have little effect on the final dosage form properties (e.g., dissolution characteristics). Thus, there exist only a few studies of this subject. In the present study, calcium stearate/ibuprofen pellets were used as model system to investigate the impact of the drying conditions. Lipophilic calcium stearate matrix pellets containing 20% ibuprofen were prepared via wet extrusion/spheronization. Subsequently, desiccation, fluid-bed drying, and lyophilization were applied for granulation liquid removal. The impact of these drying techniques on the final pellet properties was evaluated. The in vitro dissolution behavior was dramatically altered by the drying techniques that were considered. The investigated pellets showed drug release rates that varied as much as 100%. As no polymorphic transitions occurred during drying, we focused on two possible explanations: (a) a change in the drug distribution within the pellets and (b) a change in pellet micro-structure (porosity, pore size). The ibuprofen distribution proved to be homogeneous regardless of the drying c...Continue Reading

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Citations

Aug 29, 2013·Journal of Pharmaceutical Sciences·Simone SchrankEva Roblegg
Mar 4, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·N JedingerE Roblegg
Jun 11, 2016·International Journal of Pharmaceutics·Simone SchrankEva Roblegg
Nov 25, 2016·Pharmaceutical Development and Technology·Yu XiaWen-Qing Wang
Jul 1, 2020·Pharmaceutics·Martin SpoerkAmrit Paudel

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