An update on microcrystalline cellulose in direct compression: Functionality, critical material attributes, and...

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Microcrystalline cellulose (MCC) is a widely used excipient in direct compression (DC) tablet formulations due to its excellent tabletability, particularly for poorly compressible active pharmaceutical ingredients.
• The increasing variety of MCC grades from different manufacturers introduces variability in material properties, posing challenges for consistent tablet production.
• MCC-based co-processed excipients are gaining interest for their ability to combine multiple functionalities, simplifying tablet formulations.

Purpose of the Study:

• To review recent advancements in the application of MCC for direct compression tableting.
• To evaluate the impact of MCC variability on tablet quality and identify critical material attributes (CMAs).
• To explore the development and applications of MCC-based co-processed excipients.

Main Methods:

• Literature review focusing on recent studies related to MCC in DC tableting.
• Analysis of the influence of MCC properties on tablet quality attributes.
• Examination of MCC-based co-processed excipients and their functionalities.

Main Results:

• Variability in MCC properties can significantly affect the quality of DC tablets.
• Identification of potential critical material attributes (CMAs) for MCC is essential for Quality by Design (QbD) approaches.
• MCC-based co-processed excipients offer versatile solutions for complex tablet formulations.

Conclusions:

• Understanding and controlling MCC variability is vital for ensuring consistent tablet quality in pharmaceutical manufacturing.
• The identification of CMAs for MCC supports the implementation of Quality by Control strategies.
• MCC-based co-processed excipients represent a promising area for developing advanced and functional pharmaceutical formulations.