Optimization and stability evaluation of a pediatric spironolactone oral suspension: Formulation development and analytical validation.

The pediatric population often faces challenges in accessing appropriate medication formulations, particularly for circumstances like congenital heart disease requiring spironolactone therapy. This study aimed to optimize the pharmaceutical formulation of oral suspension spironolactone for pediatric use and assess its stability. A formulation with 0.2 % xanthan gum in InOrpha® was developed, showing improved stability and reduced sedimentation. Analytical method validation confirmed accuracy and precision for spironolactone quantification, while forced degradation studies ensured stability-indicating capability. Stability assessments demonstrated the oral suspension's chemical, physical, and microbiological stability for up to 135 days pre-bottle opening and 37 days post-opening under varied storage conditions. This study provides crucial insights into enhancing spironolactone formulation for pediatric patients. Further research is needed to assess pharmacokinetic parameters such as bioavailability and pharmacodynamics to fully ascertain its efficacy in pediatric populations.