Prediction of the induction period of crystallization of naproxen in solid dispersion using differential scanning calorimetry |
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Authors: | Yasuo Yoshihashi Etsuo Yonemochi Youri Maeda Katsuhide Terada |
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Institution: | (1) Faculty of Pharmaceutical Sciences, Toho University, Miyama 2-2-1, Funabashi Chiba, 274-8510, Japan; |
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Abstract: | The induction period of crystallization of amorphous naproxen in solid dispersion was measured by DSC. Hydroxypropylmethylcellulose
acetate succinate LG (HPMCAS-LG) was selected as a polymer of solid dispersion, because of the excellent inhibitory effect
of crystallization. Naproxen was chosen as a model drug having poor water solubility and poor physical stability of glassy
state. The prediction of crystallization of amorphous naproxen in solid dispersion at the desired storage temperature or the
desired polymer content was carried out. If the storage condition satisfied the requirement that was either more than 90%
of HPMCAS-LG content at 333 K or below storage temperature of 301 K for 50% HPMCAS-LG content, the induction period of crystallization
of naproxen in solid dispersion would be more than 1 year. The storage period of amorphous drug in solid dispersion of desired
storage temperature and desired drug content might be predictable from measurement data of induction period of crystallization. |
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