УДК 615.014.4:543
DOI: https://doi.org/10.52540/2074-9457.2025.4.76
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В. Б. Климашевич1, А. И. Жебентяев2, Е. А. Янович1

ИСПОЛЬЗОВАНИЕ РИСК-ОРИЕНТИРОВАННОГО ПОДХОДА ПРИ ИССЛЕДОВАНИЯХ СОВМЕСТИМОСТИ КОМПОНЕНТОВ И СТАБИЛЬНОСТИ ЛЕКАРСТВЕННОГО ПРЕПАРАТА «РАНОЛАЗИН-НАН, 500 МГ»

1Государственное предприятие «АКАДЕМФАРМ», г. Минск, Республика Беларусь

2г. Витебск, Республика Беларусь

 

Описаны результаты оценки совместимости ранолазина со вспомогательными веществами разработанного состава и исследования стабильности лекарственного препарата «Ранолазин-НАН, таблетки пролонгированного действия, покрытые оболочкой, 500 мг». С целью определения оптимальных условий хранения готового продукта, полупродуктов и подбора первичной упаковки изучена фотостабильность и гигроскопичность лекарственного препарата «Ранолазин-НАН, таблетки пролонгированного действия, покрытые оболочкой, 500 мг». Образцы таблеток промышленных серии лекарственного препарата «Ранолазин-НАН, таблетки пролонгированного действия, покрытые оболочкой, 500 мг» переданы для исследования стабильности в первичной упаковке (контурной ячейковой упаковке из алюминиевой фольги и белой двухслойной пленки на основе поливинилхлорида и поливинилиденхлорида (ПВХ/ПВДХ)) и вторичной упаковке (картонной пачке, содержащей четыре контурные ячейковые упаковки с инструкцией по медицинскому применению). Данный вид упаковки обеспечил надлежащую защиту таблеток лекарственного препарата от факторов воздействия окружающей среды, и демонстрирует совместимость между таблетками на основе ранолазина и материалом упаковки. Проведена предварительная оценка и ранжирование рисков для целевого профиля качества лекарственного препарата «Ранолазин-НАН, таблетки пролонгированного действия, покрытые оболочкой, 500 мг» методом FMECA, а также итоговая переоценка рисков после введения плана корректирующих и предупреждающих действий, который позволил эффективно снизить риски с высоких и средних до низких.

Ключевые слова: совместимость, стабильность, ранолазин, фотостабильность, гигроскопичность.

 

SUMMARY

B. Klimashevich, A. I. Zhebentyaev, E. A. Yanovich

USING A RISK-BASED APPROACH IN THE STUDIES OF COMPONENTS COMPATIBILITY AND DRUG "RANOLAZINE-NAN, 500 MG STABILITY

The results of ranolazine compatibility evaluation with the excipients of the developed formulation and the medicinal product "Ranolazine-NAN, prolonged-release film-coated tablets, 500 mg" stability studies are described.

To determine optimal storage conditions for the finished product, intermediates and to select primary packaging, the photostability and hygroscopicity of the medicinal product "Ranolazine-NAN, prolonged-release film-coated tablets, 500 mg" were studied. Samples of tablets from industrial batches of the medicinal product "Ranolazine-NAN, prolonged-release film-coated tablets, 500 mg" were submitted for stability testing in primary packaging (aluminum foil blister packs and a white two-layer film based on polyvinyl chloride and polyvinylidene chloride (PVC/PVDC)) and secondary packaging (a cardboard pack containing four blister packs together with the instructions for medical use). This type of packaging provided appropriate protection of the tablets from environmental factors and demonstrated compatibility between ranolazine-based tablets and the packaging material. A preliminary risk assessment and ranging risks for the target quality profile of the medicinal product "Ranolazine-NAN, prolonged-release film-coated tablets, 500 mg" were carried out using the FMECA method as well as the final risk reassessment following the implementation of a corrective and preventive action plan, which effectively reduced risks from high and medium levels to low levels.

Keywords: compatibility, stability, ranolazine, photostability, hygroscopicity.

 

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Климашевич В. Б.

Поступила 16.12.2025 г.