Quality Control of Pharmaceutical Excipients during Storage and Processing
The structure of pharmaceutical excipients as a function of storage time and temperature was analyzed by small- and wide-angle X-ray scattering using the SAXSpace system.
Pharmaceutical formulation is a process in which dif-ferent chemical substances (excipients), including an active pharmaceutical ingredient (API), are combined to produce a final product. Many pharmaceutical for-mulations contain excipients (e.g. lipids, stearates), which exhibit self- assembled, nano-sized structures and which can be easily monitored using small-angle X-ray scattering (SAXS).
Aging or disruption of the pharmaceutical product does typically not involve changes in the material’s crystalline structure (analyzed by XRD). In fact aging of the product can be rather related to changes of its self-organized, nano-sized structures, which can only be studied by SAXS.
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