SPIRONOLACTONE ORAL SUSPENSION (5 mg/mL): FORMULATION STRATEGIES AND PHYSICOCHEMICAL CHARACTERIZATION

Abstract

Spironolactone is widely prescribed, but its conventional solid dosage forms are often unsuitable for pediatric, geriatric, or dysphagic patients. This study aimed to develop and evaluate a stable 5 mg/mL spironolactone oral suspension for individualized dosing and improved adherence. Micronized spironolactone was incorporated stepwise into an aqueous base containing xanthan gum, VIVA pur, and potassium sorbate, followed by comprehensive physicochemical characterization including particle size, viscosity, pH, redispersibility, and drug content uniformity via HPLC. The developed suspension was homogeneous, viscous, and readily redispersible, exhibiting excellent physical and chemical stability, uniform drug distribution, and meeting pharmacopoeial standards. This pharmaceutically acceptable and patient-friendly oral suspension offers a flexible alternative for individualized dosing, potentially enhancing therapeutic adherence and optimizing clinical outcomes in vulnerable populations.
Background: Spironolactone is a potassium-sparing diuretic widely used in cardiovascular and endocrine disorders. Conventional solid dosage forms are often unsuitable for pediatric, geriatric, or dysphagic patients.
The aim of this study is to develop and evaluate a spironolactone oral suspension (5 mg/mL) suitable for individualized dosing and clinical use.
Methods: Micronized spironolactone was incorporated stepwise into a base containing xanthan gum, VIVA pur, potassium sorbate, and purified water. Key physicochemical parameters, including particle size distribution, sedimentation, viscosity, pH, redispersibility, and drug content uniformity, were assessed. Amber glass and PET bottles with droppers were used for packaging.
Results: The suspension was homogeneous, viscous, and redispersible, with uniform drug distribution and adequate flow properties. HPLC analysis confirmed content uniformity.
Conclusion: The developed oral suspension is a pharmaceutically acceptable, patient-friendly formulation that facilitates individualized dosing and may improve therapeutic adherence in populations requiring alternative dosage forms.