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Selection of excipients for dispersible tablets of itraconazole through the application of thermal techniques and Raman spectroscopy

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Abstract

For the development of dispersible tablets of itraconazole (ITR), techniques of thermal, Raman spectroscopy, and isothermal stress testing (IST) were used to assess the compatibility of ITR with selected excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. Raman spectrum of drug–excipient mixture was also compared with that of pure drug and excipient. Compatibility of excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, PEG-4000 was found to exhibit interaction with ITR. However, the results of Raman and IST studies showed that all the excipients used in the formula were compatible with ITR. Overall, compatibility of excipients with ITR was successfully evaluated using the combination of DSC, Raman spectroscopy, and IST techniques.

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Acknowledgements

This work has been supported by the prospective joint research project of Jiangsu province (BY2012193) and the Fundamental Research Funds for the Central Universities (CXZZ12_0119).

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Authors and Affiliations

  1. College of Chemistry and Chemical Engineering, Southeast University, Nanjing, 211189, People’s Republic of China

    Yan Wang, Yang-Hui Luo, Jing Zhao & Bai-Wang Sun

  2. Nanjing Tefeng Pharmaceutical Co. Ltd., Nanjing, 211314, People’s Republic of China

    Bai-Wang Sun

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  1. Yan Wang
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  2. Yang-Hui Luo
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  3. Jing Zhao
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Correspondence to Bai-Wang Sun.

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Wang, Y., Luo, YH., Zhao, J. et al. Selection of excipients for dispersible tablets of itraconazole through the application of thermal techniques and Raman spectroscopy. J Therm Anal Calorim 115, 2391–2400 (2014). https://doi.org/10.1007/s10973-013-3330-x

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  • DOI: https://doi.org/10.1007/s10973-013-3330-x

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