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Solid State Compatibility Studies With Tablet Excipients Using Non Thermal Methods.

K. Liltorp, T. Larsen, Birgitte Willumsen, R. Holm
Published 2011 · Chemistry, Medicine

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Compatibility between two new active pharmaceutical ingredients (API) and several pharmaceutical excipients used in solid formulations has been investigated by FT-IR and HPLC following storage under two different conditions. Compatibility was investigated by storage at isothermal stress conditions for (i) 3days and subsequently analysed by FT-IR and (ii) 12weeks of storage and analysis by HPLC. For the majority of the examined excipients a large degradation measured by HPLC after 12weeks storage was also detected by FT-IR following storage at isothermal stress conditions for 3days, i.e. there was a general agreement between the results obtained by the two protocols. Further, the FT-IR method showed clear incompatibility with three excipients where no degradation products were detected by HPLC, but where a significant decrease in the API quantified by the HPLC assay, was observed. The accelerated method thus showed a clear advantage: incompatibility found after 12weeks using HPLC was seen after 3days with FT-IR. Furthermore, FT-IR provides an insight into structural changes not seen with HPLC. This is exemplified by the desalting of a hydrogen bromide salt of one of the two compounds, which might lead to changes of the intrinsic dissolution rate and potentially affect the bioavailability of the API.
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