Microspheres
Optimize microsphere development: Leverage in silico release forecasts and microstructure insights for streamlined formulation and production.
Issue
The performance of microsphere systems designed for controlled release are dictated by the arrangement of polymer, porosity, and active ingredient. When these factors are ignored and treated as a black box, it extends the costs needed for development. This is tied to the lengthy formulation-release testing cycle, where the feedback loop for formulation design can rely on weeks to months of in vitro testing.
Common Challenges
- No method to determine porosity and API properties within the microsphere.
- Limited ways to elucidate the release mechanism and polymer behavior.
- Lengthy development cycles due to long in vitro testing.
- Lacking methods to demonstrate Q3 microstructural equivalence for generic development.
Related Applications
Solution
Microsphere platform development doesn’t need to be so difficult. We encourage our customers to formulate and manufacture through a quality by design approach, using the internal microstructure arrangement for faster decision making. This includes in silico release prediction based on characterized structures, enabling a rapid exploration of the formulation and manufacturing space.
Our microsphere analysis applies a correlative approach with FIB-SEM and X-ray Microscopy analysis, ensuring both a high level of detail and batch representativeness. In silico release prediction based on the real world structures can be run in a matter of days, enabling faster formulation and process selection. Quantified microstructure data and release profiles can be used in NDA and ANDA filings to demonstrate understanding of the final drug product microstructures and quality. We support all microencapsulation systems, including beads, microparticles, and microcapsules.
Our Approach
- Internal, 3D quantification of porosity and API quality attributes.
- Post-release and stability tested sample analysis to evaluate structural changes.
- In silico release prediction to shorten development cycles.
- NDA and ANDA data package support.
Formulations
Studied
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