A compression behavior classification system of pharmaceutical powders for accelerating direct compression tablet...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Direct compression (DC) is a preferred method for tablet manufacturing due to its efficiency.
• Characterizing powder behavior under compression is crucial for successful DC tablet formulation.
• Existing methods may not fully capture the complex interplay of factors influencing tabletability.

Purpose of the Study:

• To develop and validate a comprehensive compression behavior classification system (CBCS) for pharmaceutical powders intended for DC.
• To introduce a novel tabletability index (d) for categorizing tensile strength versus pressure relationships.
• To establish predictive models for tablet tensile strength and solid fraction using material properties and compression parameters.

Main Methods:

• Development of a CBCS incorporating seven descriptors from compression models.
• Proposal and explanation of a new tabletability index 'd'.
• Characterization of 130 materials, with 70 used to validate the CBCS.
• Application of Principal Component Analysis (PCA) and Partial Least Squares (PLS) regression.

Main Results:

• The CBCS effectively categorizes powder compressibility, compactibility, and tabletability.
• The new index 'd' successfully differentiates tensile strength-pressure relationships.
• PCA revealed latent structures in compression variables, grouping materials and variables.
• PLS models accurately predicted tablet tensile strength and solid fraction.
• A multi-objective design space was identified for DC tablet formulation.

Conclusions:

• The developed CBCS provides a robust framework for classifying pharmaceutical powders for DC.
• The tabletability index 'd' offers valuable insights into powder performance.
• The identified design space aids in optimizing material selection and compression parameters for efficient DC tablet manufacturing.