Granules
Optimize drug manufacturing with our approach, focusing on ingredient physicochemistry to minimize variability and enhance quality during scale-up and changes.
Issue
As drug product manufacturing is scaled and processing evolves, variability in performance and quality can arise. These challenges can be addressed through a closer understanding of ingredient physicochemistry during the formulation stage, derisking variability upon scale up and downstream manufacturing changes. Characterization of granules is a key stepping stone in this process.
Common Challenges
- Limited techniques to quantify the complex interplay of ingredients within the granulation
- Downstream manufacturability and quality issues rooted in oversimplified formulation strategies
- Dissolution variability during scale up and technology transfer
- Long development times and resources spent optimizing manufacturing
- Lack of discriminatory in vitro methods to guide formulation and anticipate in vivo performance
Related Applications
Solution
Our mission is to transform the approaches around development through a deeper assessment of ingredient interactions and compressibility within powder blends and granulations. Our solution is applied across the entire development process, including formulation, manufacturing, stability testing, and scale up for clinical trials. Through high-resolution microscopies and advanced structural analysis, insights about ingredient interaction and porosity have proved critical in optimizing performance and troubleshooting challenges. Using in silico mass transport modeling we provide a direct connection between microstructures and dissolution. We often analyze neat drug substances, excipients, spray-dried dispersions, and tablets to evaluate material property evolution upstream and downstream.
Our Approach
- 3D powder bed analysis to quantify ingredient mixing and compaction
- Guide formulation design through quantitative analysis of ingredient interactions
- De-risk scale up and tech transfer challenges with structural benchmarks
- Assessment of granule fate; impact on tablet porosity and quality
- Build correlative process models to identify critical process parameters and critical quality attributes
- In silico particle dissolution for deterministic assessment of performance
Formulations
Studied
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