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<p>The bioequivalence of finished dosage forms obtained from pharmaceutical compositions containing amorphous and crystalline forms of <i>N</i>-butyl-1,5-dideoxy-1,5-imino-D-glucitol as the active ingredient was demonstrated. Pharmaceutical compositions based on different aggregate forms of the active ingredient were shown to have different abilities to accumulate electrical charge. The use of an amorphous form was a possible solution to reduce technological losses in the production of a finished medicinal product based on <i>N</i>-butyl-1,5-dideoxy-1,5-imino-D-glucitol because of the lower electrification of the amorphous form of the main substance.</p>

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Effect of Crystalline and Amorphous Forms of N-butyl-1,5-dideoxy-1,5-imino-D-glucitol on Technological Processes in Production of the Finished Dosage Form

  • 期刊论文

  • 发表日期：

    2025年2月1日

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  • A. V. Voronov,
  • L. M. Gapoyan,
  • K. D. Chertkov,
  • E. T. Zhilyakova,
  • E. A. Veretennikov

摘要

The bioequivalence of finished dosage forms obtained from pharmaceutical compositions containing amorphous and crystalline forms of N-butyl-1,5-dideoxy-1,5-imino-D-glucitol as the active ingredient was demonstrated. Pharmaceutical compositions based on different aggregate forms of the active ingredient were shown to have different abilities to accumulate electrical charge. The use of an amorphous form was a possible solution to reduce technological losses in the production of a finished medicinal product based on N-butyl-1,5-dideoxy-1,5-imino-D-glucitol because of the lower electrification of the amorphous form of the main substance.