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

• Published in: Pharmaceutical chemistry journal Vol. 59; no. 4; pp. 491 - 499
• Main Authors: Grushevskaya, L. N., Gaevaya, L. M., Markeev, V. B., Sergeeva, M. S., Dorofeev, V. L.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.07.2025
• Subjects: Medicine; Methods of Analysis and Process Control; Organic Chemistry; Pharmacology/Toxicology; Pharmacy; Structure of Chemical Compounds; GML-3; packaging; excipients; tablets; photostability; film coating
• ISSN: 0091-150X; 1573-9031
• DOI: 10.1007/s11094-025-03420-1

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.