文摘:苯磺酸氨氯地平是一种抗高血压药物，推荐用于儿童和青少年高血压的管理。市售的2.5 mg, 5mg和10mg苯磺酸氨氯地平片剂在治疗儿童时没有提供必要的剂量灵活性。这种灵活性很容易实现使用口服，液体剂型。然而，氨氯地平目前还没有商业液体剂型。从纯药粉或商业片剂中临时合成悬浮液将提供一个方便的选择，以满足患者的特殊需求。本研究的目的是确定临时复合苯磺酸氨氯地平悬浮液在PCCA碱的物理化学稳定性。本基是一种无糖，无对羟基苯甲酸酯，无染料，无麸质触变载体，含有从罗汉果中获得的天然甜味剂。研究设计包括两种苯磺酸氨氯地平浓度，以在括号内的浓度范围内提供稳定性文件，供配药药剂师最终使用。建立并验证了一种用于测定苯磺酸氨氯地平悬浮液化学稳定性的鲁棒稳定性指示高效液相色谱法。在SuspendIt中制备氨氯地平悬液，浓度为0.5 mg/mL和10.0 mg/mL，选择代表药物通常给药的范围。 Samples were stored in plastic amber prescription bottles at two temperature conditions (5°C and 25°C). Samples were assayed initially, and at the following time points: 7 days, 14 days, 29 days, 46 days, 60 days, 90 days, 120 days, and 180 days. Physical data such as pH, viscosity, and appearance were also noted. All measurements were obtained in triplicate. A stable extemporaneous product is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period. This study demonstrates that amlodipine besylate is physically and chemically stable in SuspendIt for 90 days in the refrigerator and 7 days at room temperature, retaining 90% of the label claim (initial drug concentration) at both concentrations. The pH values did not change significantly. The viscosity of the refrigerated samples at both concentrations decreased slightly, while that of the room temperature samples showed a marked increase in viscosity. This study provides a viable, compounded alternative for amlodipine in a liquid dosage form, with an adequate beyond-use-date to meet patient needs. The study further provides stability documentation over a bracketed amlodipine concentration range of 0.5 mg/mL to 10.0 mg/mL, allowing compounding pharmacists more flexibility in customizing their formulations.