Early understanding the polymorphism profile of an active pharmaceutical ingredient (API) is a critical issue, not only because of patent-related issues, but also because a company can lose very significant time and money initiating its development with a form that is not the most stable one.
Drugabilis, has developed a systematic small-scale polymorphism screening methodology to quickly address the question: “Are we currently developing the most appropriate form of our API?”
Drugabilis polymorphism step-by-step program would include:

  • A micro-crystallization screening with API samples to maximize the chances to generate polymorphs, hydrates or solvates.
  • A comprehensive characterization of the generated forms by a number of techniques including optical microscopy, hot-stage microscopy, chromatography, Raman microscopy, thermo gravimetric analysis coupled to infrared analysis, differential scanning calorimetry and X-ray diffraction.

After a few weeks and with less than 1g of compound, Drugabilis guaranties a full polymorphism overview of your API, knowing how many crystalline forms - hydrates, solvates or true polymorphs – exist.

  • Drugabilis will then determine which form you should select for development, based on ad hoc physicochemical characterizations.
  • Based on the above studies, Drugabilis will also develop methods for assessing polymorphism purity in drug substances or drug products.
  • Drugabilis will support process chemistry in defining suitable crystallisation conditions to produce the desired crystalline form