RD&C’s SOLID STATE REACTION PLATFORM is a completely novel, innovative, and comprehensive analysis concept for efficient evaluation and prediction of solid phase reactions. It is applicable at various stages of the drug development process in a very flexible way and supports faster drug development with optimized outcome and lower failure rates.
Forced degradation studies are an essential step in the design of a regulatory compliant stability program for drug development that involves subjecting active pharmaceutical ingredients, unpackaged and/or packaged drug products to harsher conditions such as extreme pH, high temperature, moisture, light, oxygen, metals, etc. The reaction conditions are very artificial and do not reflect the actual conditions in a solid drug formulation due to inadequate, artificially triggered reaction pathways, adverse liquid matrix effects, superimposed solvent mediated reactions, and/or the prevalence of side reactions triggered by elevated temperatures.
The SOLID STATE REACTION PLATFORM provides better understanding of complex chemical reaction pathways occurring in solid phase, which would enable drug developers to better characterize their products with an improved quality aspect. The clients will benefit from faster development with optimized outcome and lower failure rates. A better assessment of the formulation will result in an optimized drug product composition with high stability and long shelf-life conferring competitive advantage to the client.
The concept of the SOLID STATE REACTION PLATFORM was successfully invented and developed and implemented by RD&C, the platform is open for further customized development, cooperation and out-licensing. The platform generates important supportive data in the preclinical phase of pharmaceutical R&D with high time and cost-effectiveness.
Essential information can be gained for
- solid state stability and shelf-life
- degradation products and pathways
- polymorph changes
- development of solid formulations
- suitability of analytical method
- quality of drug substance and drug product
- safety of drug substance and drug product
The project was funded by aws Innovative Services Call.
