Compatibility study between diazepam and tablet excipients

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• 作者：A. P. S. Matos ; J. S. Costa ; J. Boniatti…
• 关键词：Diazepam ; Compatibility study ; Thermal analysis ; Spectroscopy ; Physicochemical interactions
• 刊名：Journal of Thermal Analysis and Calorimetry
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：127
• 期：2
• 页码：1675-1682
• 全文大小：
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Physical Chemistry; Analytical Chemistry; Polymer Sciences; Inorganic Chemistry; Measurement Science and Instrumentation;
• 出版者：Springer Netherlands
• ISSN：1588-2926
• 卷排序：127

文摘

Compatibility between diazepam (DZP), a benzodiazepine drug used for the treatment of anxiety, and tablet excipients has been investigated by thermal analysis (differential scanning calorimetry—DSC and thermogravimetry—TG) and infrared (IR) spectroscopy. In order to investigate possible interactions, the components were prepared in 1:1 (w/w) mixtures. Moreover, individual samples as well as physical mixtures were stored in accelerated conditions at 40 °C/75 % RH for 3 months. Mixtures, which showed possible interactions, were also investigated in other ratios based on typical pharmaceutical solid formulation. DSC curves of DZP have shown an endothermic peak at 132 °C, which corresponds to the melting process in agreement with the literature. DSC curves of the mixtures containing DZP and colloidal silicon dioxide (CSD) indicated a possible interaction due to enthalpy values lower than expected. However, as this interaction was not confirmed by IR and TG, this suggests that these techniques are not sensitive enough to identify such interaction. These results suggest that there is a possible interaction, but not an incompatibility between DZP and CSD. For all other mixtures, it was not possible to identify significant interactions, suggesting that there are no compatibility issues.