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首页> 美国卫生研究院文献>Springer Open Choice >Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review
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Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review

机译：鼻用药物输送装置：临床角度的特征和性能-综述

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Nasal delivery is the logical choice for topical treatment of local diseases in the nose and paranasal sinuses such as allergic and non-allergic rhinitis and sinusitis. The nose is also considered an attractive route for needle-free vaccination and for systemic drug delivery, especially when rapid absorption and effect are desired. In addition, nasal delivery may help address issues related to poor bioavailability, slow absorption, drug degradation, and adverse events in the gastrointestinal tract and avoids the first-pass metabolism in the liver. However, when considering nasal delivery devices and mechanisms, it is important to keep in mind that the prime purpose of the nasal airway is to protect the delicate lungs from hazardous exposures, not to serve as a delivery route for drugs and vaccines. The narrow nasal valve and the complex convoluted nasal geometry with its dynamic cyclic physiological changes provide efficient filtration and conditioning of the inspired air, enhance olfaction, and optimize gas exchange and fluid retention during exhalation. However, the potential hurdles these functional features impose on efficient nasal drug delivery are often ignored. With this background, the advantages and limitations of existing and emerging nasal delivery devices and dispersion technologies are reviewed with focus on their clinical performance. The role and limitations of the in vitro testing in the FDA guidance for nasal spray pumps and pressurized aerosols (pressurized metered-dose inhalers) with local action are discussed. Moreover, the predictive value and clinical utility of nasal cast studies and computer simulations of nasal airflow and deposition with computer fluid dynamics software are briefly discussed. New and emerging delivery technologies and devices with emphasis on Bi-Directional™ delivery, a novel concept for nasal delivery that can be adapted to a variety of dispersion technologies, are described in more depth.
机译：鼻腔给药是局部治疗鼻子和鼻副鼻窦局部疾病（例如过敏性和非过敏性鼻炎和鼻窦炎）的合理选择。鼻子也被认为是无针疫苗接种和全身药物输送的诱人途径，尤其是在需要快速吸收和效果的时候。此外，鼻腔给药可能有助于解决与生物利用度差，吸收缓慢，药物降解以及胃肠道不良事件有关的问题，并避免肝脏中的首过代谢。但是，在考虑鼻腔输送装置和机制时，请务必牢记，鼻道的主要目的是保护脆弱的肺部免受危险的暴露，而不是用作药物和疫苗的输送途径。狭窄的鼻瓣和复杂的回旋鼻部几何结构及其动态的周期性生理变化，可对吸入的空气进行有效的过滤和调节，增强嗅觉，并在呼气期间优化气体交换和流体滞留。但是，这些功能特征对有效鼻腔药物输送的潜在障碍通常被忽略。在这种背景下，对现有和新兴的鼻腔输送设备和分散技术的优势和局限性进行了综述，重点是其临床性能。讨论了FDA指导中针对局部作用的鼻喷雾泵和加压气雾剂（加压定量吸入器）体外测试的作用和局限性。此外，简要讨论了鼻腔铸模研究的预测价值和临床实用性以及使用计算机流体动力学软件对鼻腔气流和沉积进行计算机模拟。更加深入地介绍了以Bi-Directional™递送为重点的新兴递送技术和设备，Bi-Directional™递送是一种适用于各种分散技术的鼻腔递送新概念。

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