Stability of an Extemporaneously Compounded Oral Suspension of Bosentan

摘要

Purpose: To assess the stability of an extemporaneously compounded oral suspension of bosentan from commercially available tablets for a period of 1 month.Methods: A 6.25 mg/mL oral suspension of bosentan monohydrate was prepared from Tracleer tablets. The bosentan suspension was then evenly divided between 2 light-resistant prescription bottles and stored in the dark either under refrigeration (4-8°C) or at controlled room temperature (21-26°C). The suspensions were assessed for physical changes (ease of resuspendability, change in color, change in odor), and samples were drawn immediately after preparation and on days 0, 1, 3, 7,10, 14, 21, 28, and 31. Samples were analyzed at each time point by high-performance liquid chromatography (HPLC) utilizing a reversed-phase column with chemical stability defined as the retention of at least 90 of the initial intact bosentan concentration measured.