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<p>Since the pronounced photosensitivity of the API GML-3, a compound with anxiolytic and antidepressant activity, has been previously shown, the aim of the present study was to select methods for protecting GML-3 in a solid dosage form (tablets) from exposure to light. The effect of electromagnetic radiation in the near ultraviolet and visible spectral ranges on the stability of GML-3 as part of a dosage form was studied in accordance with regulatory requirements under various conditions, e.g., in a model mixture with excipients, in a tablet mass, and as part of tablet cores and film-coated tablets. It was shown that GML-3 as part of tablets is also subject to photodegradation, but the excipients used in the production of GML-3 tablets do not cause or accelerate this process. Application of Opadry® II 85F18422 film coating made it possible to reduce the degree of GML-3 degradation, but its complete elimination under experimental conditions was achieved only when using primary and secondary packaging in the form of polypropylene jars placed in cardboard packs.</p>

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Structure of Chemical Compounds, Methods of Analysis and Process Control Photostability Study in Pharmaceutical Development of a Solid Dosage Form of GML-3, A New Compound with Anxiolytic and Antidepressant Activity

  • 期刊论文

  • 发表日期：

    2025年7月1日

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  • L. N. Grushevskaya,
  • L. M. Gaevaya,
  • V. B. Markeev,
  • M. S. Sergeeva,
  • V. L. Dorofeev

摘要

Since the pronounced photosensitivity of the API GML-3, a compound with anxiolytic and antidepressant activity, has been previously shown, the aim of the present study was to select methods for protecting GML-3 in a solid dosage form (tablets) from exposure to light. The effect of electromagnetic radiation in the near ultraviolet and visible spectral ranges on the stability of GML-3 as part of a dosage form was studied in accordance with regulatory requirements under various conditions, e.g., in a model mixture with excipients, in a tablet mass, and as part of tablet cores and film-coated tablets. It was shown that GML-3 as part of tablets is also subject to photodegradation, but the excipients used in the production of GML-3 tablets do not cause or accelerate this process. Application of Opadry® II 85F18422 film coating made it possible to reduce the degree of GML-3 degradation, but its complete elimination under experimental conditions was achieved only when using primary and secondary packaging in the form of polypropylene jars placed in cardboard packs.