An Integrated Approach for High-Shear Wet Granulation (HSWG) Processing of TPGS-Based Formulations: Demonstration of...

Area of Science:

• Pharmaceutical Technology
• Chemical Engineering
• Materials Science

Background:

• The non-ionic surfactant TPGS presents challenges in oral solid dosage forms due to its low melting point.
• Limited literature exists on TPGS-based high-shear wet granulation (HSWG) formulations and practical scale-up knowledge.

Purpose of the Study:

• To investigate the impact of HSWG processing conditions on product attributes for TPGS-containing tablets.
• To establish a scalable and robust HSWG process for TPGS-based formulations.
• To extend the application of TPGS in tablet formulations through HSWG.

Main Methods:

• An exploratory study was conducted to assess the effects of extreme HSWG processing conditions.
• A factorial design of experiments (DoE) was employed to analyze HSWG variables and their interactions.
• Process scale-up and product transfer were evaluated across different granulator types.

Main Results:

• Successful process scale-up and product transfer from laboratory to commercial scale were achieved.
• The TPGS-based formulation exhibited robust downstream processing, including improved flowability and reduced segregation potential.
• A wide HSWG operating space was identified, demonstrating minimal impact on product performance across various granulators.

Conclusions:

• HSWG is a viable granulation method for TPGS-containing tablet formulations.
• The developed HSWG process is robust and scalable, ensuring consistent product attributes.
• This study provides valuable insights for processing TPGS-based formulations using HSWG technology.