Aptuit | Integrated CMC | Analytical method development

Material sciences and pre-formulation

The key to innovation

Aptuit has expertise and a wealth of experience in material science and pre-formulation. Our integrated team of material scientists, analysts and formulators have an extensive knowledge in implementing all of the necessary analysis and characterization tools, allowing for the selection of the best formulation approach.

Aptuit | Material sciences and pre-formulation

The pre-formulation step is based on two main investigation areas:

  • In silico and in vitro tools for a better understanding of the biopharmaceutical elements
  • Solid state characterization of API, excipients and preliminary formulations

The combination of the obtained results allows the Aptuit CMC development team, by linking together the expertise of formulation development, material science, analytical chemistry to guide and narrow the investigational fields among the potential available formulations.

GastroPlus® simulation, bio-relevant dissolution models, animal PK models, thermal analysis, particle size analysis, spectroscopy methods, X-Ray Powder Diffraction, microscopy and chemical imaging are among our wide range of tools available to perform the pre-formulation activity.