Particle Homogenization with Mesoporous Silica
Active pharmaceutical ingredients (APIs) can exist in multiple crystal forms, known as polymorphs, that are chemically identical but lead to deviations across batches affecting stability, tableting properties, flowability, solubility, and release kinetics, and may ultimately result in a change in processability and drug (product) performance. These changes must be identified and addressed as they can have a significant impact on the success of the program, project timelines, investment of resources and product safety and efficacy.
Mesoporous silica as a porous carrier formulation technology can be used to:
- Stabilize unstable polymorphs via nanoconfinement of the amorphous form of the API in its unique pore structure
- Optimize solid-state properties, delivering consistency in particle size, flowability, tablet hardness, and friability independent of the API
The strategy can be used across a broad range of APIs and can thus serve as a one-size-fits-all platform technology for consistent particle properties leading to more efficient formulation development processes and de-risking solid state variation during drug development.
All supported by the Emprove® Program with comprehensive documentation to speed up your way to the market. Whenever applicable, our products are compliant with the major pharmacopeias.
Multi-functional for Solubility Enhancement and Particle Engineering
An innovative platform technology for reliable formulation and more efficient tableting processes. Benefit from a consistent solid-state profile, reduced risk of unstable polymorphism and improved API flowability, compressibility and particle homogeneity. Suitable for direct compression and continuous manufacturing.
Related Product Resources
- Download: Formulation Handbook
In this formulation handbook, we have compiled information and formulation examples that can help you when developing your formulation.
- Parteck® SLC Excipient Brochure: Drug Substance, Meet Drug Product
A platform approach to manage particle and polymorph variation.
- Parteck® SLC Excipient White Paper: Use of a Platform Formulation Technology to De-Risk Solid-State Variation in Drug Development
This white paper describes use of mesoporous silica as a porous carrier formulation technology to stabilize unstable polymorphs and to optimize solid state properties.
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