Quality Assessment of Extemporaneously Compounded Carvedilol Oral Suspension for Pediatric Patients at the Hospital Pharmacy
Iman M. Alfagih *
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Alanood Almurshedi
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Basmah Aldosari
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Bushra Al Quadeib
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Enas Zakaria
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Eram Eltahir
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Khadijh Alnakhli
Department of pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia and Nahdi Medical Company, Riyadh, Saudi Arabia.
*Author to whom correspondence should be addressed.
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.
Keywords: Quality assessment, extemporaneous compounding, carvedilol, oral suspension, pediatrics