A tabletability change classification system in supporting the tablet formulation design via the roll compaction and...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Tablet formulation design relies on understanding material properties and processing behavior.
• Roll compaction and dry granulation (RCDG) is a common technique for producing granules for tablets.
• Predicting tabletability changes and associated risks during RCDG is crucial for successful formulation.

Purpose of the Study:

• To investigate tabletability changes in various materials processed via RCDG.
• To develop a classification system for tabletability changes (TCCS).
• To create a risk decision tree for tablet formulation design using RCDG.

Main Methods:

• A material library of 31 materials was characterized using physical and compression behavior parameters.
• Materials were processed through RCDG, and granules were sieved into different size fractions.
• Tabletability changes were assessed using the relative change of tabletability (CoT_r) index, leading to the TCCS.
• A risk decision tree was developed by integrating compression behavior classification system (CBCS) and TCCS.

Main Results:

• Approximately 65% of materials exhibited a loss of tabletability (LoT), increasing to 84% for larger granules.
• A risk decision tree identified specific material categories and tabletability change types associated with formulation risk.
• Risk assessment was validated using a latent variable model for predicting tablet tensile strength.

Conclusions:

• The combination of CBCS and TCCS provides a valuable tool for material selection in RCDG-based tablet formulation.
• Understanding and classifying tabletability changes is essential for mitigating formulation risks.
• The developed risk decision tree aids in informed decision-making for optimizing tablet production via RCDG.