In this research we investigated combinations of optics and diffraction methodologies that would allow an accurate quantifi cation of an Active Pharmaceutical Ingredient (API) in a typical pharmaceutical oral dosage form. All methodologies investigated allow non-destructive testing for the uniformity of the API content in a batch. We used Indometacin tablets as an example of a typical solid oral dosage form. The results show that different types of solids with different shapes and particle sizes require different diffraction geometries and/or data collection strategies.
During the manufacturing process of tablets, small variations in processing parameters, for example in temperature or in pressure - may change the morphology of the fi llers or the crystalline state of the active ingredient in the final product. Since these changes may affect the bioavailability of the drug there is an increasing need to non-destructively analyze the fi nal oral dosage form.