Browsing by Author "Tran, Jennie"
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Item The Stability of Quetiapine Fumarate 10 mg/mL Compounded Oral Suspension in Ora-Blend and Ora-Sweet Vehicles Over Time at Two Temperatures(2018-03-14) Gervase, Melissa; Evans, Jason; Dong, Xiaowei; Tran, JenniePurpose: Quetiapine fumarate (QF) is an atypical antipsychotic agent that is used off-label for the treatment of delirium in critically-ill children. QF is commercially available as immediate and extended-release tablets for oral administration. Although there is a published 40 mg/ml compounded suspension, this is not suitable for small doses, and there is no stability data available for QF compounded suspension. Therefore, the objective of this study was to evaluate the stability of 10 mg/mL QF compounded oral suspension in Ora-Blend (OB) vehicle and Ora-Sweet (OS) vehicle by analyzing drug contents, dissolved drug in selected vehicles, pH, visual appearance and odor at two temperatures up to 90 days. Methods: QF compounded suspensions (10 mg/mL) were prepared from QF commercial tablets in either OB or OS vehicle and were stored in plastic amber bottles at either 22°C or 2°C. At day 0, 7, 60 and 90, three bottles from each condition were used to prepare samples for the high-performance liquid chromatography (HPLC) analysis that was developed and validated. The drug contents were measured by directly mixing QF suspension with MeOH:H20 (v/v) and diluting the supernatant with MeOH after centrifugation to a detectable concentration for HPLC analysis. To measure dissolved QF, QF suspension was centrifuged and then QF in the supernatant was measured by HPLC. pH was measured by a pH meter, and physical characteristics were analyzed based on the changes in color and odor. Results: The QF drug contents in OB and OS for 90 days were not significantly different compared to day 0 at two temperatures. QF in OB remained dissolved over time at two temperatures, whereas QF in OS was precipitated out at day 7 and 90. The pH of both OB and OS preparations was consistent from day 0 to day 90. There were no significant differences in visual appearance or odor for both OB and OS preparations overtime at two temperatures. Conclusions Based on the results of drug contents, dissolved drug, pH and physical characteristics, QF compounded suspensions in OB were stable at two temperatures for up to 90 days. Compared to OS, OB is the better vehicle to prepare QF compounded suspensions. Keyword: Quetiapine fumarate, Stability testing, HPLC, PediatricsItem The stability of quetiapine oral suspension compounded from commercially available tablets(PLOS, 2021-08-10) Tran, Jennie; Gervase, Melissa A.; Evans, Jason; Deville, Rebecca; Dong, XiaoweiQuetiapine fumarate (QF) is an atypical antipsychotic used off-label for the treatment of delirium in critically-ill infants and children. For the treatment of pediatric populations or patient populations with trouble swallowing tablets, an oral suspension would be an ideal dosage formulation. However, there are no liquid formulations of QF commercially available. Therefore, a compounded oral suspension prepared from the commercial QF tablets is widely used in clinical settings. The extemporaneous preparation of QF compounded oral suspension changes the formulation from a solid form to a liquid form. Thus, the stability of QF compounded oral suspension should be critically evaluated to guide pharmacists for administration and storage of QF compounded oral suspensions. However, the stability of the nonaqueous oral QF suspension was not measured. The objective of this study was to develop QF compounded oral suspensions at 10 mg/mL by using commercial QF tablets in two readily available aqueous vehicles (Ora-Sweet and Ora-Blend) and measure their stability at both room temperature and under refrigeration. Physical stability of the QF compounded suspensions were evaluated by appearance and odor. Chemical stability of the QF compounded suspensions were evaluated based on pH, degradation, drug content and the amount of the drug dissolved in the vehicles. An HPLC method was validated and used to evaluate QF compounded suspensions over 60 days. In addition to the total drug in the suspensions, the dissolved drug in the vehicles was also measured during the stability testing and evaluated as a stability parameter. Overall, QF suspension prepared in Ora-Blend was preferable, demonstrating a superior 60-day stability at both room temperature and refrigerated storage.