Development of Spray-Dried Mannitol-Pregelatinized Rice Starch Using SeDeM-Based Approach for Direct Compressible...

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Direct compression (DC) is cost-effective but limited by poor powder flow and compressibility.
• Co-processing excipients can overcome these limitations for DC tablet manufacturing.

Purpose of the Study:

• To develop and optimize a co-processed excipient of mannitol and pregelatinized rice starch (PRS) for direct compression.
• To evaluate the excipient's powder flow, compressibility, and tablet-forming properties.

Main Methods:

• Spray drying was used to co-process 98% mannitol and 2% PRS with ammonium bicarbonate as a pore-forming agent.
• The SeDeM expert system guided optimization and component evaluation.
• Physicochemical characterization included SEM, DSC, FTIR, and XRD.
• Cetirizine dihydrochloride tablets were formulated and tested against pharmacopeial standards.

Main Results:

• The co-processed excipient demonstrated balanced powder flow and enhanced compressibility.
• Characterization confirmed no chemical interactions or changes in wettability.
• Formulated tablets met all pharmacopeial requirements, showing good disintegration and dissolution profiles.

Conclusions:

• The co-processed mannitol-PRS excipient is suitable for direct compression applications.
• The SeDeM methodology enabled predictive optimization of powder properties.
• This represents the first application of SeDeM to this specific co-processed system.