Ge Yuanyuan, Xu Xingying, Cao Meng, Liu Baijun, Wang Ying, Liao Ping, Wang Jiajing, Chen Yifei, Yuan Hongmei, Chen Guiliang
School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China.
Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China.
Pharmaceutics. 2024 Jul 11;16(7):929. doi: 10.3390/pharmaceutics16070929.
Nasal administration is a non-invasive method of drug delivery that offers several advantages, including rapid onset of action, ease of use, no first-pass effect, and fewer side effects. On this basis, nose-to-brain delivery technology offers a new method for drug delivery to the brain and central nervous system, which has attracted widespread attention. In this paper, the development status and trends of nasal drug delivery and nose-to-brain delivery technology are deeply analyzed through multiple dimensions: literature research, questionnaire surveys, and patent analysis. First, FDA-approved nasal formulations for nose-to-brain delivery were combed. Second, we collected a large amount of relevant information about nasal drug delivery through a questionnaire survey of 165 pharmaceutical industry practitioners in 28 provinces and 161 different organizations in China. Third, and most importantly, we conducted a patent analysis of approximately 700+ patents related to nose-to-brain delivery, both domestically and internationally. This analysis was conducted in terms of patent application trends, technology life cycle, technology composition, and technology evolution. The LDA topic model was employed to identify technological topics in each time window (1990-2023), and the five key major evolution paths were extracted. The research results in this paper will provide useful references for relevant researchers and enterprises in the pharmaceutical industry, promoting the further development and application of nasal drug delivery and nose-to-brain delivery technology.
鼻腔给药是一种非侵入性给药方法,具有多种优势,包括起效迅速、使用方便、无首过效应和副作用较少。在此基础上,鼻脑给药技术为药物输送至大脑和中枢神经系统提供了一种新方法,受到广泛关注。本文通过文献研究、问卷调查和专利分析等多个维度,对鼻腔给药和鼻脑给药技术的发展现状与趋势进行了深入分析。首先,梳理了美国食品药品监督管理局(FDA)批准的用于鼻脑给药的鼻腔制剂。其次,通过对中国28个省份的165名制药行业从业者和161个不同组织进行问卷调查,收集了大量有关鼻腔给药的相关信息。第三,也是最重要的,我们对国内外约700多项与鼻脑给药相关的专利进行了专利分析。该分析从专利申请趋势、技术生命周期、技术构成和技术演进等方面展开。采用潜在狄利克雷分配(LDA)主题模型识别每个时间窗口(1990 - 2023年)的技术主题,并提取了五条关键的主要演进路径。本文的研究结果将为制药行业的相关研究人员和企业提供有益参考,推动鼻腔给药和鼻脑给药技术的进一步发展与应用。