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Thanks to the broad range of indications and therapeutic benefits in diverse patient populations, spironolactone is a commonly used drug. The extemporaneous preparation of spironolactone oral suspension in hospital pharmacies is routinely performed to meet the needs of neonates and pediatric patients in pediatric clinics, as well as hospitalized patients in other clinics with various adaptation requirements for drug administration. The stability of spironolactone oral suspension, according to existing literature, varies depending on different concentrations and preparation prescriptions. To investigate the stability of spironolactone oral suspension and assess the potential influence of the licensed drug used in preparation, we compounded two oral suspensions from spironolactone film-coated tablets produced by two manufacturers available on the market in Bosnia and Herzegovina, using the same method and prescription for preparation. Utilizing highly sophisticated HPLC technology, the stability of 5 mg/mL spironolactone oral suspensions was tested and evaluated in relation to the generic drug excipients used in compounding. The suspensions were stored in a refrigerator and tested over a 90-day period. The suspensions remained stable regardless of the composition of the film-coated tablets, with the measured content of the active substance not falling below 96% of the declared concentration. The differences observed in the suspensions were related to the measured pH value, but these differences did not affect the stability of spironolactone.

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Testing and Stability Evaluation of Spironolactone Suspensions 5 mg/ml Prepared Under the Conditions of Galenic Laboratory of Hospital Pharmacy

  • 会议论文

  • 发表日期：

    2026年

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  • Senida Katerji,
  • Saša Pilipović,
  • Mubera Mandžo,
  • A. Uzunović,
  • Minela Dacić,
  • Aida Šapčanin

摘要

Thanks to the broad range of indications and therapeutic benefits in diverse patient populations, spironolactone is a commonly used drug. The extemporaneous preparation of spironolactone oral suspension in hospital pharmacies is routinely performed to meet the needs of neonates and pediatric patients in pediatric clinics, as well as hospitalized patients in other clinics with various adaptation requirements for drug administration. The stability of spironolactone oral suspension, according to existing literature, varies depending on different concentrations and preparation prescriptions. To investigate the stability of spironolactone oral suspension and assess the potential influence of the licensed drug used in preparation, we compounded two oral suspensions from spironolactone film-coated tablets produced by two manufacturers available on the market in Bosnia and Herzegovina, using the same method and prescription for preparation. Utilizing highly sophisticated HPLC technology, the stability of 5 mg/mL spironolactone oral suspensions was tested and evaluated in relation to the generic drug excipients used in compounding. The suspensions were stored in a refrigerator and tested over a 90-day period. The suspensions remained stable regardless of the composition of the film-coated tablets, with the measured content of the active substance not falling below 96% of the declared concentration. The differences observed in the suspensions were related to the measured pH value, but these differences did not affect the stability of spironolactone.