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Exploration of ethyl anthranilate-loaded monolithic matrix-type prophylactic polymeric patch
Journal of Food and Drug Analysis ( IF 3.6 ) Pub Date : 2017-10-01 , DOI: 10.1016/j.jfda.2016.11.002
Johirul Islam 1, 2 , Kamaruz Zaman 2 , Srijita Chakrabarti 1 , Nilutpal Sharma Bora 1 , Manash Pratim Pathak 1 , Santa Mandal 1 , Julfikar Ali Junejo 2 , Pronobesh Chattopadhyay 1
Affiliation  

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.

中文翻译:

邻氨基苯甲酸乙酯整体基质型预防性高分子贴剂的探索

载有挥发物的药物制剂的稳定性受损是与设计用于递送挥发性化合物的装置相关的严重问题。本研究的重点是评估由挥发性邻氨基苯甲酸乙酯组成的基质型聚合物贴剂用于预防媒介传播疾病的稳定性潜力。邻氨基苯甲酸乙酯负载的基质型聚合物贴片通过溶剂蒸发法在不渗透的背膜上制造,并附在临时释放衬垫上。根据国际协调会议 (ICH) 指南在加速条件下对聚合物贴剂进行为期 6 个月的稳定性测试。此外,残留溶剂的定量也按照 ICH 指南进行。在进行了 6 个月的稳定性研究后,优化的贴片在药物含量、物理外观和其他分析参数的均匀性方面显示出最佳结果。此外,发现残留溶剂的量远低于可接受的限度。因此,本报告概述了要评估的分析参数,以确保由挥发性化合物组成的某些设备的稳定性。
更新日期:2017-10-01
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