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Eur J Pharm Biopharm:新型阿莫达非尼微针贴片对睡眠剥夺负面影响的改善作用

2021-10-28 Vivi MedSci原创

口服睡眠剥夺的治疗药物--阿莫达非尼有一定的局限,新型微针给药可以弥补这种不足,可考虑临床应用。

睡眠剥夺是指由于环境变化或其他不可抗因素导致的睡眠时间缩短、睡眠质量下降,在主动或被动状态下无法满足正常的生理需求。长期睡眠不足会导致疲劳、情绪障碍、记忆丧失,甚至认知障碍。一般来说,睡眠剥夺是睡眠缺失的一种病理状态,可显著损害身体的体力和能量。睡眠不足或部分睡眠不足在工作环境(轮班和长时间工作)、持续的军事行动、运动员跨越几个时区参加比赛等情况下都很常见。

阿莫达非尼作为一种口服制剂,临床上主要用于治疗白天睡眠过多的发作性睡病、抑郁症患者、特发性嗜睡或发作性睡眠症,用药剂量往往较大。此外,在驾驶或执行任务时,可能不方便吞咽,也不方便及时停止给药。因此,有必要寻找更方便的给药途径,如经皮、鼻腔或黏膜给药,使其更适合、更有效地应用于临床。

经皮给药通常具有给药方便、剂量可调、依从性高等优点,但角质层是药物吸收的主要障碍。传统的皮肤给药依赖于药物在皮肤上的被动扩散,而促进药物吸收的手段依赖于可逆性破坏角质层以增强吸收。微针作为一种新的物理渗透增强透皮给药技术,因其生物相容性、生物降解性、可调节释放谱和优良的给药能力而备受关注。

微针可在皮肤内产生瞬时微通道,促进多肽、抗体、寡核苷酸和纳米粒子的有效透皮,可能打破高分子量药物的透皮限制。例如,溶解性微针贴片一般由数百个长度约为25-1000 μm的不同针阵组成,可直接将角质层和表皮切片,以促进最佳药物递送。然而,锰的使用可能会受到其自身体积的很大限制,从而导致低载药量,而且很难适应唤醒剂的剂量要求。此外,在制备微针的过程中,高药量和适当的机械强度往往相互矛盾,这也是研究的一大挑战。

近日在Eur J Pharm Biopharm发表的一项研究,采用聚乙烯吡咯烷酮(PVP) K90在甲醇中溶解、干燥后,采用模压法制备载阿莫达非尼微针,制备机械强度高、载药量大的微针。通过COMSOL Multiphysics®软件模拟和通用机械试验机验证了更高的机械强度。获得的阿莫达非尼微针可承受70 N的力,可穿透皮肤230 μm深度。

采用高效液相色谱法测定微针阿莫达非尼释药速率,结果提示在体外1.5 h内快速释放药物。建立睡眠剥夺小鼠模型,评价阿莫达非尼微针的效应。

行为学实验(水迷宫实验,高架+迷宫测试)显示,模型组与健康组的行动轨迹存在显著差异,提示睡眠剥夺可能会降低小鼠的空间记忆能力。但给药组的时间与健康组基本相似,说明阿莫达非尼微针对改善睡眠剥夺小鼠的认知功能和空间记忆能力有显著影响。高架+迷宫测试的目的是潜在地检测动物的焦虑,观察表明,对照组和微针给药组睡眠不足老鼠的焦虑状态均明显缓解,并能持续保持小鼠健康的好奇心和探索精神。

药代动力学分析(LC-MS/MS测定)表明,微针贴片给药后,小鼠血液中阿莫达非尼的含量显著增加,其浓度与口服阿莫达非尼的药物浓度相当。与口服给药相比,微针给药能维持更持久、更稳定的血药浓度。

组织病理学观察提示,模型组可见核萎缩和深染,提示睡眠剥夺小鼠脑细胞坏死,神经元严重受损,提示睡眠剥夺可能导致海马CA1区病变,而口服和微针给药后明显改善。

皮质酮测定结果显示,剥夺睡眠72 h后,与健康组相比,模型组小鼠血清皮质酮水平显著升高。与模型组比较,对照组和微针组小鼠血浆皮质酮明显降低

脑源性神经营养因子BDNF检测显示,剥夺睡眠72 h后,小鼠海马区BDNF表达明显下降,与模型组相比,微针给药组BDNF表达明显升高。

研究证明,阿莫达非尼微针可显著改善睡眠不足大鼠的认知水平,从而减轻睡眠剥夺对小鼠的各种不良影响。作为一种潜在的新途径,微针可以补充口服途径的不足,消除与睡眠剥夺相关的副作用。新的阿莫达非尼微针贴片可以应用于试点或其他专业人群,因此在不同的临床环境中具有重要的应用潜力

文献来源:

Zhu, L., Zhang, S., Yu, X., Zhu, S., Ou, G., Li, Q., Zhang, Y., Wang, L., Zhuang, X., Du, L., & Jin, Y. (2021). Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, S0939-6411(21)00264-2. Advance online publication. https://doi.org/10.1016/j.ejpb.2021.10.009

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    2021-12-16 sunylz
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    2022-04-23 jj000001
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