A new approach to accelerated drug-excipient compatibility testing

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Development

Background:

• Accelerated storage testing is crucial for predicting drug stability but is time-consuming.
• Understanding drug-excipient interactions is vital for formulation development.
• Current methods for assessing degradation and interactions can take up to a month.

Purpose of the Study:

• To develop a rapid method for predicting drug degradants and probing drug-excipient interactions.
• To significantly reduce the time required for stability testing compared to traditional methods.
• To establish a practical and reliable screening technique for pharmaceutical formulations.

Main Methods:

• Investigated various stressing methods to mimic accelerated degradation.
• Developed a novel technique for qualitative prediction of degradants.
• Utilized a solid dosage form of drug substance SB-243213-A for testing.
• Compared results against accelerated storage testing at 50 degrees C.

Main Results:

• The developed method successfully mimicked one month of accelerated degradation in just one hour.
• Identified two oxidative impurities formed from drug substance SB-243213-A degradation.
• The method demonstrated suitability for automated analysis and multi-sample stressing.
• Achieved degradation levels comparable to three months of storage testing within the rapid timeframe.

Conclusions:

• The novel method offers a significantly faster alternative to conventional stability testing.
• This technique is ideal for efficient drug-excipient compatibility screening.
• The developed approach accelerates the prediction of drug degradation pathways and impurity formation.