Accelerated Degradation of Pharmaceuticals and Related Chemical Processes

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.

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.

Advantages:

-Faster

-More efficient

-Reliable

-Potential to speed up FDA licensing process

Potential Applications:

-Pharmaceutical industry

-Drug development

TRL: 5

Intellectual Property:

Keywords: Forced degradation, active pharmaceutical ingredient stability, API shelf life, Leidenfrost droplets, nanospray mass spectrometry, accelerated drug stability testing, pharmaceutical development, FDA licensing, drug stability analysis, fast forced degradation, Chemistry and Chemical Analysis, Degredation, Drug Management, Medical/Health, Pharmaceuticals