- Raw material compatibility studies
We will perform stability studies on your API versus commonly used formulation excipients plus any raw materials you may suggest. With our industrial experience, our studies simulate your products; therefore, the results will have a better prediction to the true product.
- Solubility profiles
We will custom design solubility profile studies based on your product needs. The well designed studies may help you solve formulation problems, such as:
- Dissolution method for a poorly-water soluble drug
- Formulation strategies for a poorly-water soluble drug
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IVIVC issues
- Stability for suspensions, oral solutions, and injectables
- BCS category analysis
Biological Classification System is a FDA classification system for the new drug applications. We can help you test your API and perform BCS analysis that can help your filing and more importantly, to predict IVIVC risk of your formulations.
- Particle size analysis
Particle size analysis is a critical study in formulation development of poorly-water soluble drugs. Our expertise in formulation of poorly-water soluble drugs will ensure you that the data from our lab are better fit to your formulation needs.
- API stability characterization
API stability studies will provide an inside look at the stability of your drug substance. It can give you guidance on how to formulate your product. With our formulation experience in oral solids, oral liquids, semi-solids and injectables, we can custom design API stability studies for your product.