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Excipient Compatibility Testing

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 a thorough but focused excipient compatibility testing program built from these technologies:

  • UPLC, HPLCs with UV, RI, PDA, electrochemical, conductivity, MS, and fluorescence detectors and GCs with FID and TCD
  • ICP/AA
  • 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 development and into pharmacies. They will use their experience to structure a prioritized testing program that maximizes efficiency and cost savings while giving you 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 with a chemical structure that indicated the potential for oxidative degradation and hydrolysis. The 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 with the API, as well as antioxidants to further prevent degradation. With this data, we were able to focus efforts on a formulation that would offer maximum stability.

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