Knowledge of the physicochemical properties of excipients is just as important as comprehensive understanding of a drug molecule. Physicochemical characterization is the objective of the pre-formulation stage, and the knowledge gleaned during this stage is crucial both for the development of a dosage form and for the quality control of raw materials as well as finished pharmaceutical products.
Differential Scanning Calorimetry (DSC) is the method of choice for the identification of the physical form of a molecule and the determination of its Glass Transition TemperatureThe glass transition is one of the most important properties of amorphous and semi-crystalline materials, e.g., inorganic glasses, amorphous metals, polymers, pharmaceuticals and food ingredients, etc., and describes the temperature region where the mechanical properties of the materials change from hard and brittle to more soft, deformable or rubbery.glass transition or Melting Temperatures and EnthalpiesThe enthalpy of fusion of a substance, also known as latent heat, is a measure of the energy input, typically heat, which is necessary to convert a substance from solid to liquid state. The melting point of a substance is the temperature at which it changes state from solid (crystalline) to liquid (isotropic melt).melting point, enthalpy of fusion, and polymorphic forms. It is also a useful tool for screening the compatibility between excipients and drugs. Thermogravimetric analysis (TGA), in turn, is the method for determining the release of solvent adsorbed or entrapped on the lattice of the molecules in hydrates and solvates; and therefore, is applicable for determination of loss on drying and water content, as well as hygroscopicity (when coupled to a humidity generator). Rheology can give relevant information about the flow and viscoelasticity of excipients under different conditions, like those seen during the manufacturing and packaging of drug products.
During this webinar, we will discuss the application of thermal analysis, DSC and TGA for characterizing α-lactose monohydrate and the influence of humidity on its physical form. We will also discuss how to use rheology to determine the cohesion energy DensityThe mass density is defined as the ratio between mass and volume. density, a relevant parameter for determining the flowability of a powder.