To formulate your drug substance into a successful drug product you need to have a firm scientific understanding of the physical characteristics of your drug substance and the way it interacts with the other materials that may be present in the formulated drug product.

At Aptuit we can help you to characterize your drug substance and drug products in a number of ways, including light and stereo microscopy to define approximate particle characteristics, using light diffraction technology to determine particle size characteristics, and using a Freeman Technology’s FT4 to understand the rheological properties of your material. We also have the capability to use Differential Scanning Calorimetry to determine the melting point of your drug substance or the possibility of polymorphs or the glass transitions if your drug substance is crystalline.

Risk Analysis of physico-chemical and biopharmaceutical properties of your API is fundamental to ensure the appropriate in-vivo performance. At Aptuit we conduct selective physico-chemical profiling that helps you to identify the non "drug like" properties of a molecule and an assessment of associated risk from both from a biopharmaceutical and pharmaceutical technology point of view. Our scientists can perform thermodynamic and kinetic solubility measurement, Intrinsic Dissolution Rate testing and solid state characterization.

Application of predictive modeling for oral absorption and state of the art In Vitro characterization like dissolution testing allows biopharmaceutical evaluation of your drug substance, comprising the identification of an effective formulation strategy for preclinical and clinical testing.

As the majority of oral dosage forms are composed of a variety of materials, understanding how your drug substance interacts with the other materials in the formulation is critical for the success of your drug development program. Our preformulation scientists have significant experience with performing excipient compatibility studies. We can set down a number of chosen materials related to the dosage form in a binary mixture with your drug substance and test this at an aggressive condition for main peak assay to determine the compatibility of your drug substance and the materials under test.