Quality and Stability Evaluation of Extemporaneously Compounded Losartan Potassium Oral Suspension at the Hospital Pharmacy

Abstract

Aims: The purpose of this study was to evaluate the quality of an extemporaneous formulation of losartan potassium oral suspensions from crushed losartan potassium tablets to ensure that the compounded suspension maintained its quality attributes during its storage period. Methodology: Losartan potassium suspensions were compounded extemporaneously in the same way they are prepared for patients at a hospital pharmacy. The suspensions were kept in the refrigerator at 4°C and evaluated immediately and after 9, 18, and 28 days. Suspension ease of redispersion, color, odor, pH, particle size, zeta potential, viscosity, and sedimentation volume were all evaluated. In addition, microbiological stability, drug content, and drug dissolution were assessed. Results: During the study period, the extemporaneously compounded suspension retained its color and odor, and the pH profile remained consistent. Moreover, all suspensions were easily resuspended in a homogeneous liquid with gentle shaking, and no caking was detected. Furthermore, the results of the microbiological test revealed no microbial growth. The content uniformity and dissolution test results met the pharmacopeial requirements. The findings revealed that the losartan potassium compounding procedure was reliable and capable of producing 2.5 mg/mL of losartan potassium suspension using commercially available tablets and Ora-Blend as a suspending vehicle. Furthermore, after 28 days in the refrigerator (4°C), the suspension had acceptable quality features. Conclusion: Extemporaneously compounded suspension allows physicians to prescribe a variable dose that adjusts to each patient’s needs, providing treatment when the liquid dosage form is unavailable.