Address API challenges with amorphous solid dispersion services
Increase the solubility and stability of your APIs to produce a more stable solid form. Amorphous APIs pose challenges due to higher energy states, lower stability and significantly poor absorption rates. Our solid dispersion technology prevents the drug from reverting to its crystalline form during dispersion — increasing bioavailability, reducing food effect and delivering therapeutic benefits more effectively.
Amorphous solid dispersion benefits
- Broad applicability over a diverse compound property space
- Accommodates high dose applications for safety studies
- Applicable for either tableting or encapsulation as drug product formats
- Applicable for extended-release and combination formulations
- Compatible with both tablet (MR, XR) and capsule formats
- Enable the development of extended-release and combination therapies to enhance treatment options
- Scale processes seamlessly and ensure reproducibility
Formulation methods
When a solid dispersion is determined to be the proper approach for addressing bioavailability issues, either spray drying or HME technologies will be used to formulate the drug. Best practices have been developed for technology transfer between spray drying and HME. For example, spray drying is often used for feasibility, preclinical and phase I studies due to lower API requirements, whereas HME may be used later to lower manufacturing costs and scale operations.
This is typically based on several target product profile considerations, including:
- Physical and chemical stability
- Drug loading requirements
- Food effect and variability
- Combination versus single API products
- Commercial consideration
Amorphous solid dispersion manufacturing
Utilizing polymers
Utilizing polymers enhances the solid-state stability of ASDs to ensure consistent performance and reliability throughout the formulation process. The polymer is selected based on its ability to stabilize the amorphous drug.
Characterization techniques
Once the ASD is formed, various techniques confirm its amorphous nature and help us understand its properties.
Stability studies
We conduct stability studies to ensure that the ASD is physically stable over time. This involves storing the dispersion under various conditions and monitoring any changes in its physical properties.