Development and Characterization of Multifunctional Directly Compressible Co-processed Excipient by Spray Drying...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Poorly compressible drugs present formulation challenges, impacting tablet manufacturing and drug performance.
• Developing effective excipients is crucial for improving drug delivery and manufacturability.

Purpose of the Study:

• To develop and characterize a multifunctional co-processed excipient for enhancing the compressibility of poorly compressible drugs.
• To optimize the composition of the co-processed excipient using a D-optimal mixture design.

Main Methods:

• Co-processing of microcrystalline cellulose (MCC), lactose monohydrate, and StarCap 1500 using spray drying.
• Optimization of excipient composition using D-optimal mixture design and desirability function.
• Evaluation of flow properties, compressibility (Kawakita's, Kuno's, Heckel's equations), and dilution potential.

Main Results:

• The optimized co-processed excipient composition was 30% MCC, 25% lactose, and 45% StarCap.
• The optimized excipient exhibited excellent flow properties (angle of repose, Carr's index, Hausner's ratio).
• Improved compressibility of the model drug Etodolac was observed, and formulated tablets met all acceptance criteria.

Conclusions:

• A multifunctional, directly compressible co-processed excipient was successfully prepared using spray drying.
• The developed excipient significantly improved the compressibility of the poorly compressible model drug Etodolac.
• Spray drying is an efficient method for producing co-processed excipients with enhanced properties.