At Patheon, we'll put the experience of thousands of projects to work when helping you to achieve the ideal dose form for your new drug product. A key component of this effort will be thorough but focused excipient compatibility testing program.
Excipient compatibility testing technologies
- UPLC, HPLCs with UV, RI, PDA, electrochemical, conductivity, MS, and fluorescence detectors and GCs with FID, TCD, and MS detectors
- TGA and DSC
- IR, UV, and NIR spectroscopy
- ICH capable stability
Through Patheon, you'll have access to top scientists who have the expertise to understand your molecule and foresee the long-term impact of excipients on your formulation as your product progresses through the entire development cycle. They will use their experience to structure a prioritized testing program that maximizes efficiency and cost savings while giving you rock-solid results to build a successful product.
Case Study: Stability Through Excipient Compatibility Testing
The Challenge A customer came to Patheon with a new molecule that’s chemical structure indicated potential for oxidative degradation and hydrolysis. Their goal was to develop a solid oral dosage form that overcame these stability issues.
The Solution To determine the level of degradation caused by specific excipients, Patheon conducted binary testing of dry and wet mixtures of API and multiple excipients. By employing accelerated conditions, this method of excipient compatibility testing allowed us to evaluate potency and impurities over a 1-3 month period.
The Outcome Patheon identified excipients not prone to degradation and incorporated antioxidants to further prevent degradation. With this data, we were able to focus efforts on a formulation with maximum stability.