Intranasal administration of antiseizure drugs using new formulation trends: one step closer to reach clinical trials.

Sara Alexandra Meirinho, Márcio José de Abreu Marques Rodrigues, Gilberto Lourenço Alves
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Abstract

Introduction: Although there are numerous options for epilepsy treatment, its effective control continues unsatisfactory. Thus, search for alternative therapeutic options to improve the efficacy/safety binomial of drugs becomes very attractive to investigate. In this context, intranasal administration of antiseizure drugs formulated on state-of-the-art nanosystems can be a promising strategy.

Areas covered: This work gives a comprehensive overview of different intranasal nanosystems for antiseizure drug administration developed and evaluated on preclinical studies over the last 10 years and published in 'PubMed' and 'Web of Science' databases. Additionally, it highlights their pharmaceutical critical quality attributes and in vivo pharmacological outputs that might infer possible results when transposing to clinical trials.

Expert opinion: Research into optimized nanosystems encapsulating antiseizure drugs to enhance direct nose-to-brain delivery has increased over the last years. Particularly, the interest in formulating first- and second-generation antiseizure drugs in nanoparticles is here highlighted, having demonstrated its in vivo safety and improvement on pharmacokinetic and efficacy outputs. Still, none of them were brought to clinical trials. Thus, considering the existing barriers between preclinical and clinical trials, if supported by robust and targeted quality by design approaches, intranasal drug delivery can be presented as a valid and superior alternative for epilepsy treatment.

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鼻内给药抗癫痫药物使用新配方趋势:离临床试验又近了一步。
虽然有许多治疗癫痫的选择,但其有效控制仍然令人不满意。因此,寻找替代治疗方案,以提高药物的有效性/安全性二项,成为非常有吸引力的研究。在这种情况下,鼻内给药抗癫痫药物配制的最先进的纳米系统可以是一个有前途的策略。涵盖领域:这项工作全面概述了不同的鼻内纳米系统用于抗癫痫药物管理,这些系统是在过去10年的临床前研究中开发和评估的,并发表在PubMed和Web of Science数据库中。此外,它还强调了它们的药物关键质量属性和体内药理学输出,这些属性和输出在转到临床试验时可能推断出可能的结果。专家意见:在过去的几年里,对优化的纳米系统的研究增加了抗癫痫药物的包封,以增强直接从鼻子到大脑的输送。特别是,在这里强调了第一代和第二代抗癫痫药物纳米颗粒的兴趣,证明了其体内安全性和药代动力学和功效输出的改善。不过,这些药物都没有进行临床试验。因此,考虑到临床前和临床试验之间存在的障碍,如果通过设计方法支持稳健和有针对性的质量,鼻内给药可以作为癫痫治疗的有效和优越的替代方案。
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