Division of Pharmaceutical Technology, Defence Research Laboratory, Tezpur, Assam, India.
Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh, Assam, India.
J Food Drug Anal. 2017 Oct;25(4):968-975. doi: 10.1016/j.jfda.2016.11.002. Epub 2016 Dec 5.
Compromised stability of pharmaceutical formulations loaded with volatiles is a serious problem associated with devices designed to deliver volatile compounds. The present study has been focused to evaluate the stability potential of matrix-type polymeric patches composed of volatile ethyl anthranilate for prophylaxis against vector-borne diseases. Ethyl anthranilate-loaded matrix-type polymeric patches were fabricated by solvent evaporation method on an impermeable backing membrane and attached to temporary release liners. Stability testing of the polymeric patches was performed as per the International Conference on Harmonization (ICH) guidelines for 6 months under accelerated conditions. In addition, the quantification of residual solvents was also performed as per the ICH guidelines. After conducting the stability studies for 6 months, the optimized patches showed the best possible results with respect to uniformity of drug content, physical appearance, and other analytical parameters. Furthermore, the amount of residual solvent was found well below the accepted limit. Thus, the present report outlined the analytical parameters to be evaluated to ensure the stability of a certain devices consisting of volatile compounds.
载有挥发性物质的药物制剂稳定性受损是与设计用于输送挥发性化合物的装置相关的一个严重问题。本研究集中评估了由挥发性乙基邻氨基苯甲酸酯组成的基质型聚合物贴片预防虫媒疾病的稳定性潜力。采用溶剂蒸发法将乙基邻氨基苯甲酸酯负载于基质型聚合物贴片上，贴于不渗透背衬膜上，并附有临时释放衬垫。根据国际协调会议（ICH）的指导原则，对聚合物贴片进行了 6 个月的加速条件下的稳定性测试。此外，还根据 ICH 指南进行了残留溶剂的定量测定。经过 6 个月的稳定性研究，优化后的贴片在药物含量均匀性、物理外观和其他分析参数方面表现出最佳结果。此外，残留溶剂的量低于可接受的限度。因此，本报告概述了为确保包含挥发性化合物的特定装置的稳定性而需要评估的分析参数。
