Characterization of the Formulation

The stability and suitability of the formulations also needs to be determined, for example, whether the viscosity of the formulation is suitable for the administration route and is stable over time. The water content is a parameter that often has a direct influence on the stability of solid formulations and may influence the appearance of freeze-dried products immensely. Karl-Fisher titration, thermogravitometric analysis (TGA), or DSC is normally used to determine the water content. Various microscopic techniques, where both macroscopic and microscopic appearance of formulation can be determined, such as particle appearance by scanning electron microscopy (SEM) or transmission electron microscopy (TEM), are usually only needed for special formulation. There are several other methods, but which one to choose depends entirely on the formulation and the critical parameters (149,150).

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