In-die compressibility as a surrogate for lubrication-induced changes in tabletability.

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Lubricants are crucial in tablet manufacturing, affecting ejection, compressibility, and tablet strength.
• The precise impact of lubricants on in-die compressibility and their utility in tensile strength modeling require further investigation.

Purpose of the Study:

• To systematically investigate lubricant effects (type, concentration, blending time) on tablet compressibility and tensile strength.
• To develop and validate a model for predicting tablet tensile strength based on compressibility data, independent of explicit lubricant information.

Main Methods:

• Utilized compaction simulation and compressibility analysis to study lubricants (magnesium stearate, sodium stearyl fumarate) in different formulations.
• Employed regression analysis and developed a nonlinear white-box model incorporating tablet mass and onset density.

Main Results:

• Lubricant effects on compressibility were evident early in the compression phase.
• The developed model accurately predicted tensile strength (MSE ≤ 0.20 MPa) across various materials and conditions.
• Compressibility data inherently captures lubrication-induced tabletability variations.

Conclusions:

• Tablet tensile strength can be robustly characterized using compressibility data, irrespective of specific lubricant information.
• This approach advances understanding of lubrication in compressibility-based modeling for tabletability assessment.
• The findings support formulation-independent tabletability evaluation within quality-by-design frameworks.