Shakshuki Ayah, Agu Remigius U
Biopharmaceutics and Drug Delivery Lab, College of Pharmacy, Dalhousie University, Halifax, Nova Scotia, Canada.
Int J Pharm Compd. 2019 Jan-Feb;23(1):82-87.
Extemporaneous topical compounds for neuropathic pain offers an alternative or adjunct approach to existing therapies for patients. Assigning evidence-based beyond-use dating prior to dispensing topical medications is a legal requirement by pharmacy governing bodies. The purpose of this study was to utilize a validated stability-indicating high-performance liquid chromatography assay to determine beyond-use dating of topical amitriptyline in three different bases (Lipoderm Base, PLO Gel Mediflo 30, Emollient Cream) at three different temperatures [room temperature (25°C), refrigeration (4°C), and high temperature (40°C)]. Amitriptyline was stable after 90 days at room temperature in both Lipoderm Base and PLO Gel Mediflo 30. However, it was not stable at 40°C in Emollient Cream, irrespective of storage conditions.
用于神经性疼痛的临时外用制剂为患者提供了一种替代或辅助现有疗法的方法。在分发外用药物之前确定基于证据的有效期是药学管理机构的法律要求。本研究的目的是利用经过验证的稳定性指示高效液相色谱法，确定三种不同基质（Lipoderm基质、PLO凝胶Mediflo 30、润肤霜）中的外用阿米替林在三种不同温度[室温（25°C）、冷藏（4°C）和高温（40°C）]下的有效期。在室温下，Lipoderm基质和PLO凝胶Mediflo 30中的阿米替林在90天后均稳定。然而，无论储存条件如何，它在40°C的润肤霜中都不稳定。
