Implants
Streamline implant development with our quality by design approach. Use in silico predictions and microstructure insights for faster, cost-effective innovation.
Issue
The performance of implants designed for long-acting 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 relies on months to years of in vitro testing. Implant development doesn’t need to be so difficult.
Common Challenges
- No method to determine porosity and particle properties within the implant.
- 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.
- Difficulties establishing IVIVC and performance assurance for clinical trials.
Related Applications
Solution
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, which enables a rapid exploration of the parameter space.
Our solution uses a correlative approach to study microstructures at multiple resolution scales, ensuring both a high level of detail and product 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 both NDA and ANDA filings to demonstrate understanding of the final drug product microstructures and quality. We also study post-partial release implants from in vivo and in vitro studies, enabling quantification of the drug dissolution front, polymer degradation, and other structural changes that can occur.
This analysis can offer insights into the impact of the in vivo environment on release and can support the pharmacokinetic data. Our solution for implants has been applied to ocular systems, contraceptives, and hormonal pellets. These workflows are also being applied to study long-acting injectable and in situ formed depots, examining the depot microstructure within ex vivo tissue samples.
Our Approach
- Internal quantification of porosity and API quality attributes.
- Post-release and stability sample analysis to evaluate structural changes.
- In silico release prediction to shorten development cycles.
- NDA and ANDA regulatory support.
- Comparative studies of in vivo and in vitro tested products to enable IVIVC.
Formulations
Studied
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