Parteck® SLC – A multi-functional excipient for both solubility and particle engineering
Drug solubility is a critical issue in formulation development, with more and more compounds at risk due to poor oral bioavailability. Parteck® SLC mesoporous silica is used as a solubility enhancing excipient, stabilizing the more soluble, amorphous form of a compound within nanosized pores. The high surface area of 500 m2/g and small 6nm pores enable optimal stabilization – even at high drug loads. This makes Parteck® SLC silica an ideal option for compounds with poor glass forming ability.
This unparalleled solid-state stabilization can also be leveraged to address unstable polymorphism and variable particle profiles in drug development. Control of these two parameters is critical in pharmaceutical development as they impact product performance, processability and stability. For such cases where polymorphism or particle properties are inconsistent throughout the drug development process, Parteck® SLC silica carrier can serve as a platform technology. Loading the API within the pores of the mesoporous silica provides a consistent and reliable solid-state profile, reduces the risk of unstable polymorphism and improves API flowability, compressibility and particle homogeneity. As a result, the application of Parteck® SLC excipient enables reliable formulation and more efficient tableting processes such as direct compression or continuous manufacturing.
Benefits of Parteck® SLC
- Solubility enhancement of APIs
- Unparalleled stabilization of the amorphous solid state
- Platform approach to manage API particle and polymorph variation
- Unique pore structure and high surface area
- User-friendly particle properties
- High-end application support
Our expert support team can assist you in exploring what Parteck® SLC offers – from early development up to production scale. For development studies, we are able to provide guidance and feasibility trials in our network of application labs across the globe. For production-scale loading, we have developed a validated commercial process for large-scale loading, more information is available on request.
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Related Webinars
Examine amorphous stability from a theoretical perspective in the context of polymeric solid dispersions and mesoporous silica formulations.
This webinar will present the concepts of crystal structure and polymorphism in drug development of oral solid dosage forms, will introduce CSP as an option to minimize solid-state risks, and, finally, will describe how mesoporous silica can be used as a last-resort technology to homogenize a solid form from exhibiting polymorphism.
Related Product Resources
Parteck® SLC mesoporous silica is a solubility enhancement excipient, that stabilizes the amorphous form of a compound in nanosized pores. This stabilization has been shown to be reliable and consistent, providing the same solid-state profile with a range of APIs.
Drug solubility is a critical issue in formulation development, with more and more compounds at risk due to poor oral bioavailability. Parteck® SLC is an innovative mesoporous silica excipient that can unlock the power of amorphous solubility enhancement. This is possible due to the unique pore structure of Parteck® SLC: poorly soluble molecules can be adsorbed and confined in nanosized pores, where they are stabilized in the more soluble amorphous form.
This white paper describes use of mesoporous silica as a porous carrier formulation technology to stabilize unstable polymorphs and to optimize solid state properties. The strategy can be used across a broad range of APIs and can thus serve as a platform technology for consistent particle properties leading to more efficient formulation development processes.
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