SeDeM-Guided Design and Optimization of MCC-Calcium Sulfate Co-Processed Excipient (MCCASUL) for Direct Compression...

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Direct compression is a preferred tablet manufacturing method requiring excipients with optimal flowability, compressibility, and packing properties.
• Microcrystalline cellulose (MCC) and calcium sulphate (CaSO₄) possess complementary functionalities but have individual limitations for direct compression.

Purpose of the Study:

• To develop and optimize a novel MCC-CaSO₄ co-processed excipient (MCCASUL) for direct compression applications.
• To utilize the SeDeM Expert System to determine critical material attributes and optimize the MCC:CaSO₄ ratio.

Main Methods:

• The SeDeM Expert System was employed to assess 12 parameters of MCC and CaSO₄, calculating functional indices like IPP and IGC.
• A co-dispersion method was used to prepare nine MCCASUL batches with varying ratios, guided by the SeDeM dilution potential equation.
• Optimized batches underwent further characterization using FTIR, DSC, SEM, Heckel, and Kawakita analyses.

Main Results:

• MCC demonstrated higher compressibility (ѱc=7.00) compared to CaSO₄ (ѱc=4.67).
• MCCASUL batch 4, with an optimized MCC:CaSO₄ ratio, exhibited the best performance (IPP=6.50, ѱf=7.46, ѱc=6.31).
• FTIR confirmed material compatibility, DSC indicated stable modified thermal characteristics, and SEM revealed improved morphology.

Conclusions:

• The SeDeM Expert System facilitated the development of MCCASUL, a versatile excipient with enhanced flowability, compressibility, and stability.
• Co-processing MCC and CaSO₄ effectively overcomes individual limitations, yielding a promising excipient for direct compression tablet production.
• MCCASUL shows significant potential for improving direct compression tablet manufacturing processes.