Quality Assessment of Extemporaneously Compounded Carvedilol Oral Suspension for Pediatric Patients at the Hospital Pharmacy

Abstract

Aims: The aim of this study was to evaluate different quality control parameters and the stability of the carvedilol compounded extemporaneous suspensions over three months at room temperature. Methodology: The carvedilol compounded extemporaneous suspensions were prepared in our lab in a manner consistent with how they are prepared for pediatric patients at the hospital pharmacy. The suspensions were stored at room temperature and analyzed immediately and at 1, 2 and 3 months. Suspensions were monitored for changes in organoleptic properties, pH, particle size, zeta potential, viscosity, sedimentation volume, drug content and drug dissolution. Results: The results demonstrated that the carvedilol compounding protocol used in this study was reliable and able to prepare 1.67 mg/mL of carvedilol suspension by using carvedilol commercially available tablets and Ora-blend as a suspending vehicle. Also, the extemporaneously compounded suspension maintained acceptable quality attributes when stored for three months at room temperature. Conclusion: The extemporaneously compounded suspension enables pediatricians to administer a variable dose, which adapts to every patient’s needs, and gives the possibility of treatment when the liquid dosage form is not available.