Accelerated Degradation of Pharmaceuticals and Related Chemical Processes
- Summary
- Researchers at Purdue University have developed a new forced degradation method. Using Leidenfrost droplets to accelerate forced degradation and nanospray mass spectrometry (MS) to characterize the reaction products, the reaction/analysis sequence provided results within minutes, i.e., five minutes, versus taking up to a week to complete. The FDA requires forced degradation for licensing, which causes a bottleneck in pharmaceutical production. An accelerated forced degradation method could help eliminate this bottleneck.
- Technology Benefits
- FasterMore efficientReliablePotential to speed up FDA licensing process
- Technology Application
- Pharmaceutical industryDrug development
- Detailed Technology Description
- R. Graham CooksPurdue ChemistryAston Labs
- Countries
- United States
- Application No.
- None
- *Abstract
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None
- *Background
- Forced degradation is an accelerated method of studying the stability of an active pharmaceutical ingredient (API) in order to predict the shelf life of the drug. Forced degradation studies of APIs are an important aspect of pharmaceutical development. Typical forced degradation methods take one to seven days to complete and are then followed with product analysis using liquid chromatography-mass spectrometry (LC-MS). These methods are time consuming and costly. There is a need for a more efficient method of forced degradation.
- *IP Issue Date
- None
- *IP Type
- Provisional
- *Stage of Development
- Bench testing performed
- *Web Links
- Purdue Office of Technology CommercializationPurdue Innovation and EntrepreneurshipR. Graham CooksPurdue ChemistryAston Labs
- Country/Region
- USA
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