Using a Material Library to Understand the Change of Tabletability by High Shear Wet Granulation

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Tabletability changes post-granulation are crucial for tablet formulation and process design.
• High shear wet granulation and tableting (HSWGT) is a common pharmaceutical process.
• Characterizing material properties before and after granulation is essential for predicting tablet performance.

Purpose of the Study:

• To investigate and quantify the change in tabletability of pharmaceutical materials after high shear wet granulation.
• To develop a classification system for tabletability changes.
• To identify material property differences influencing direct compression (DC) versus HSWGT.

Main Methods:

• Utilized a material library of 30 pharmaceutical materials.
• Characterized powders and granules using 19 physical properties and nine compression behavior classification system (CBCS) parameters.
• Employed Principal Component Analysis (PCA), a new index (relative change of tabletability, CoT_r), and tensile strength (TS) vs. compression pressure curves.

Main Results:

• Established a tabletability change classification system (TCCS) based on CoT_r.
• Found that 40% of materials lost tabletability (Type I), 50% remained unchanged (Type II), and 10% improved (Type III).
• Identified that increased plasticity or porosity of starting materials benefits high tablet tensile strength in HSWGT.

Conclusions:

• The TCCS offers a method for initial risk assessment in tablet formulation design.
• Data modeling aids in predicting formulation ingredient impact on compact strength.
• Understanding granulation's effect on tabletability is key for successful tablet development.