Solid state optimisation
Early characterisation of Discovery bulks often helps identifying critical milestones to be included into the drug candidate preclinical development plan. Drugabilis regularly performs these measurements on minute amounts of bulk. Based on years of experience and utilising a well-equipped characterisation platform, Drugabilis will help you characterise your API, optimise its solid-state for the desired target product profile and make the right recommendations to developers.
Early research compounds are quite often isolated as amorphous bulks after being isolated by preparative chromatography or too fast precipitated after synthesis. After evidencing a given batch is amorphous and if needed, Drugabilis can define crystallisation conditions, so that a defined crystal state of your API is engaged in your early R&D studies.
Various reasons exist for initiating or not initiating a salt selection study. Drugabilis will help you identify when to engage efforts in a salt selection process. Then using our proprietary screening methodologies and characterisation capabilities, we will then help you answer two important questions: “What counter-ions form crystals when combined to my API?” and “What salt would be the most suitable for my compound?”
Early understanding of the polymorphism profile of an API is key for making the right choice in terms of formulation strategy and confirming the desired target product profile feasibility. We have developed a systematic small-scale polymorphism screening methodology to identify the most appropriate crystal form of your API. We also help to link you with API manufacturers for producing the desired crystal state.