While many laboratories carry out method development and traditional stability studies, FreeThink scientists are especially adept at quickly solving the most challenging development problems. FreeThink scientists pride themselves on finding solutions where many others have failed.
Examples of problems FreeThink has solved for customers are detailed below.
FreeThink showed that commercial-scale production of a drug-layered bead caused formation of amorphous active which was unstable. By incorporating a process adaptation to induce recrystallization, stabilization was achieved.
When an unexpected stability failure occurred in late-stage development that was not seen in any earlier development stages, FreeThink correctly identified a problem with the analytical method, not the product itself. In this case, the customer’s development laboratory had protected analytical samples from light (amber glass) but did not note this when the method was transferred to the production site.
FreeThink found that a customer’s tablet dissolution instability was linked to deliquescence (picking up water in the air to form a solution) by the drug itself and could only be remedied by packaging. This halted the company’s significant efforts at reformulation.