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Ibuprofen-loaded calcium stearate pellets: drying-induced variations in dosage form properties
Simone Schrank1, Aden Hodzic, Andreas Zimmer
1Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology, University of Graz, Graz, Austria.
AAPS Pharmscitech
|May 4, 2012
Summary
Drying significantly impacts oral dosage form properties, altering drug release rates by up to 100%. This study highlights how drying conditions, not drug distribution, affect pellet porosity and dissolution profiles.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Oral dosage pellets are commonly manufactured using extrusion/spheronization followed by drying.
- The drying step is often considered to have minimal impact on final pellet properties, leading to limited research in this area.
Purpose of the Study:
- To investigate the influence of different drying techniques on the properties of calcium stearate/ibuprofen pellets.
- To evaluate the impact of drying on in vitro drug release characteristics.
Main Methods:
- Calcium stearate/ibuprofen pellets (20% ibuprofen) were prepared via wet extrusion/spheronization.
- Desiccation, fluid-bed drying, and lyophilization were employed for granulation liquid removal.
- In vitro dissolution behavior, drug distribution, pellet porosity, and pore size were analyzed.
Main Results:
- Drying techniques dramatically altered in vitro dissolution behavior, with drug release rates varying up to 100%.
- No polymorphic transitions of ibuprofen were observed during drying.
- While drug distribution remained homogeneous, pellet porosity and pore sizes were significantly modified by the drying process.
Conclusions:
- The drying process is a critical step that significantly influences the final properties and release profiles of oral dosage pellets.
- Understanding and controlling drying conditions are essential for achieving desired drug release characteristics.
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