Zeneth Features and Benefits
Zeneth has various features and benefits. These include:
Zeneth can swiftly provide predictions for the likely degradation products of query compounds whilst taking into account the effect of different excipients and impurities within the final formulated product. Structures of common excipients, with associated impurities, are provided for easy processing alongside the query compound.
Zeneth has comprehensive knowledge of degradation pathways which ensures structure elucidation of experimentally seen degradants. Intuitive tools allow filtering of results based on chemical formula, mass and mass difference allowing experimental data to guide predictions.
Expert ICH M7 Support
Under ICH M7, potential degradation products likely to be present in the final drug product should be evaluated for mutagenic potential. Zeneth’s comprehensive transformation library permits the identification of potential degradants.
Meeting Regulatory Requirements
Numerous guidelines (ICH Q1A/B, ICH Q3A/B, ICH M7, RDC 58/2013 and RDC 53/2015) stipulate the need to understand the consequences of degradation, and focus on impurities and stability testing. The decision support that Zeneth offers can be invaluable in meeting many of these requirements.
In addition to structural features, Zeneth accounts for a number of reaction conditions, making its predictions consistent with the conditions that have to be tested according to the ICH guidelines: thermolytic, hydrolytic, oxidative and photolytic.
Predictions are clearly represented and contain detailed supporting evidence associated with the degradation pathway. Expert commentary, including a review of data, mechanistic rationale and explanation of the structure activity relationship are also included.
Extensive Degradation Knowledge
Drawing on over 35 years of experience, Lhasa expert scientists implement and regularly update Zeneth transformations using public and proprietary data ensuring vast coverage of degradation pathways.
Advanced Warning System
Provides an instant understanding of what results might be expected when running stress tests. This additional information can increase efficiency and productivity by informing decisions, aiding the design of experiments and assisting with excipient selection.
Zeneth incorporates a reporting framework that allows (.rtf .txt .xlsx and .sdf) file export. Report templates are fully customisable by the end user.
“The benefit of predictive programs for forced degradation is even greater when you consider that information on stress testing is not readily available. As a matter of fact, forced degradation studies are expensive and time consuming, and are mainly performed on compounds that have a good chance of reaching the market. Furthermore, these studies are often conducted on highly confidential material (i.e. APIs that are already in an advanced stage of development) and may not even be published. For this reason, the field of degradation chemistry is relatively immature and generates a limited amount of publicly available data.” (Parenty et al, 2013)
Parenty et al. (2013) An Expert System To Predict the Forced Degradation of Organic Molecules, Molecular Pharmaceutics, 10 (8), pp. 2962-2974. http://pubs.acs.org/doi/abs/10.1021/mp400083h
To find out more about how Zeneth can help you, please get in touch.