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A Formulation-Process-Product Integrated Design Method for Accelerating Pharmaceutical Tablet Development via the
Zichen Liang1,2, Xuefang Tang1,2, Liping Chen1,2
1Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine, Beijing 100029, China.
Pharmaceutics
|March 27, 2025
Summary
A new formulation-process-product integrated design (FPPID) framework accelerates tablet development by simultaneously optimizing formulation and process parameters. This holistic approach enhances efficiency and decision-making in pharmaceutical manufacturing.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Tablets are the most popular oral solid dosage form.
- High-shear wet granulation and tableting (HSWGT) is a common manufacturing technique.
- Conventional HSWGT development is inefficient and may lead to suboptimal outcomes.
Purpose of the Study:
- To introduce a formulation-process-product integrated design (FPPID) framework.
- To enable simultaneous exploration of formulation and process design spaces.
- To facilitate target-oriented development for HSWGT.
Main Methods:
- Utilized a material library, model-driven design (MDD), and simulation-supported solution generation.
- Developed an intermediate-level process model incorporating dimensionless parameters and partial least square (PLS) modeling.
- Interconnected mixture properties calculation and process models for predictive analysis of tablet tensile strength (TS) and solid fraction (SF).
Main Results:
- Implemented a four-step FPPID methodology: target definition, formulation simulation, process simulation, and solution generation.
- Demonstrated the framework's effectiveness in the efficient development of high-drug-loading tablets.
- Successfully predicted tablet properties based on material characteristics and process parameters.
Conclusions:
- The FPPID framework offers a holistic approach to pharmaceutical product development.
- It effectively manages the complexity of sequential development stages in HSWGT.
- The method accelerates product development by facilitating integrated decision-making.
Keywords:
formulation-process-product integrated design (FPPID)high-shear wet granulation and tableting (HSWGT)in silico simulationmaterial libraryquality by digital design (QbDD)More Related Videos
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