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一种防篡改的经皮芬太尼贴片的研制与评价。

Development and evaluation of a tampering resistant transdermal fentanyl patch.

机构信息

Division for Applied Materials Science, Department of Engineering Sciences, The Ångström Laboratory, Uppsala University, Box 534, SE-751 21 Uppsala, Sweden.

Division for Applied Materials Science, Department of Engineering Sciences, The Ångström Laboratory, Uppsala University, Box 534, SE-751 21 Uppsala, Sweden.

出版信息

Int J Pharm. 2015 Jul 5;488(1-2):102-7. doi: 10.1016/j.ijpharm.2015.04.061. Epub 2015 Apr 22.

Abstract

With the increasing number of misuse and abuse of opioids, the resistance to tampering becomes an important attribute for transdermal opioid patches. In this study, drug-containing geopolymer granules were integrated into an adhesive matrix to improve the resistance of fast drug release against some common abuse techniques. Bench testing showed that fentanyl loaded geopolymer granules had better resistance to tampering compared to a commercial fentanyl patch. Moreover, in a pilot in vivo study on a few rats, the granules showed potential to give similar drug plasma concentrations as the commercial fentanyl patch. After integrating geopolymer granules into an adhesive matrix, the new patch showed a better resistance against the investigated tampering tests compared with the commercially available patch. In this study, we showed that incorporating drug loaded geopolymer granules into a patch adhesive has potential to improve the resistance of the fentanyl patch against tampering without compromising the drug release.

摘要

随着阿片类药物的误用和滥用越来越多,抗篡改能力成为透皮阿片类药物贴片的一个重要属性。在这项研究中,载药的地质聚合物颗粒被整合到胶粘剂基质中,以提高快速释放药物对一些常见滥用技术的抗干扰能力。台架测试表明,与商业芬太尼贴片相比,负载芬太尼的地质聚合物颗粒具有更好的抗篡改能力。此外,在对几只老鼠进行的初步体内研究中,这些颗粒显示出与商业芬太尼贴片相似的药物血浆浓度的潜力。将地质聚合物颗粒整合到胶粘剂基质中后,与市售贴片相比,新贴片在经过调查的篡改测试中表现出更好的抗干扰能力。在这项研究中,我们表明,将载药地质聚合物颗粒纳入贴片胶粘剂中具有提高芬太尼贴片抗篡改能力的潜力,而不会影响药物释放。

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