DAVID TREW CONSULTING LIMITED
UNDERSTANDING AND PREDICTING THE DEGRADATION AND STABILITY OF DRUGS AND CHEMICALS
Developing an understanding of the stability and degradation chemistry of candidate new drug substances and products, and identifying their potential degradation products are critical activities that are carried out during the of a drug’s development.
A knowledge of a substance’s or product’s stability, chemistry and potential degradation products can help:
- Understand and predict a substances toxicity profile and provide early warning of possible side effects that may be encountered in latter development stages. The International Conference on Harmonisation impurity guideline1 sets thresholds for which impurities and drug degradation products should be identified.
- Identify appropriate formulation strategies that will produce stable and effective drug products, by identifying potential drug/excipient interactions
- Identify and avoid potential bioavailability issues
- Develop stability indication analytical methods
- Identify storage conditions and packaging requirements
- Determine periods of use and expiry dates
Similarly, information on the environmental fate of bulk chemicals is often required for registration and other regulatory purposes. Information about the chemical reactions of a substance is also required to reach informed conclusions about a chemical’s hazards and for creating informative material safety data sheets (MSDS).
1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline Q3B, Impurities in drug substances, 2006. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf
Leveraging our knowledge of organic chemistry, coupled with our access to online chemistry research databases, We can:
- predict the probable degradation products and the degradation pathways of drug and chemical substances, based on their likely chemical reactions under specified conditions
- Predict the stability of drugs and chemicals under specified conditions
- Provide project management services on the design, planning and execution of experimental studies to identify the degradation products of drug and chemical substances and elucidate reaction pathways
