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Abstract
Context: Novel tableting excipients are continuously developed and advertised with superior flow and compaction characteristics.
Objective: The objective of this study was to compare two traditionally used and two novel tableting excipients with regard to their physical and tableting properties as well as their magnesium stearate sensitivity. Avicel® PH102 (microcrystalline cellulose) was compared to the novel co-processed excipient Prosolv® SMCC90 (silicified microcrystalline cellulose), whereas Anhydrous Emcompress® (anhydrous dicalcium phosphate) was compared to the novel spherically granulated excipient Fujicalin® (anhydrous dicalcium phosphate).
Materials and methods: True density, particle size, specific surface area (SSA), flowability, tabletability, and magnesium stearate sensitivity of the excipients was determined.
Results and discussion: Due to the silification process (Prosolv®) and the unique manufacturing process (Fujicalin®), the novel excipients showed a comparably larger SSA. Hardest tablets by far could be obtained with Prosolv®, followed by Avicel® and Fujicalin®. Avicel® and Prosolv® were sensitive to magnesium stearate, whereas Fujicalin® and Emcompress® did not show lubricant sensitivity. This confirms the plastic deformation behavior of microcrystalline cellulose and the brittle fracture of anhydrous dicalcium phosphate.
Conclusion: Compared to the traditional excipients the investigated novel tableting excipients were advantageous with regard to their SSA and their tableting properties.
Acknowledgments
The authors would like to thank SEPPIC, JRS PHARMA, FMC BioPolymer, and Baerlocher for the donation of the excipients as well as Korsch for the provision of the XL100.
Declaration of interest
The authors report no conflicts of interest.