Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, 800 E. Leigh St, Richmond, Virginia, 23298, USA.
Bioprocess Research and Development, Sanofi Pasteur Ltd., Building 95, 1755 Steeles Avenue West, Toronto, Ontario, M2R 3T4, Canada.
Pharm Res. 2021 Jan;38(1):141-153. doi: 10.1007/s11095-020-02976-9. Epub 2021 Jan 15.
Nasal delivery is a favorable route for vaccination against most respiratory infections, as antigen deposited in the nasal turbinate and Waldeyer's ring areas induce mucosal and systemic immune responses. However, little is known about the nasal distribution of the vaccines, specifically for infants.
Anatomical nasal replicas of five subjects, 3-24 months, were developed to assess local intranasal vaccine delivery using MAD Nasal™ device, and understand impact of breathing conditions and administration parameters. High performance liquid chromatography was used to quantify the deposition pattern and determine the delivery efficiency.
The delivery efficiency on average for all models was found to be 86.57±14.23%. There were no significant differences in the total delivery efficiency between the models in all cases. However, the regional deposition pattern was altered based on the model and subsequent administration. Furthermore, removing the foam tip from the MAD Nasal™ device, to study the impact of insertion length, did not significantly increase the efficiency within the two models tested, 5- and 16-month.
Incorporating nasal replicas in testing provided a benchmark to determine the efficiency of a common intranasal vaccine delivery combination product. This proposed platform would allow comparing other potential nasal vaccine delivery devices.
鼻腔给药是针对大多数呼吸道感染进行疫苗接种的一种有利途径,因为沉积在鼻甲和瓦耳代尔环区域的抗原会引发黏膜和全身免疫反应。然而,对于疫苗在鼻腔中的分布情况,特别是针对婴儿的情况,人们知之甚少。
为了评估 MAD Nasal™装置在局部鼻腔内疫苗输送中的应用,并了解呼吸条件和给药参数的影响,我们开发了五个 3-24 个月大的受试者的解剖学鼻腔复制品。采用高效液相色谱法来量化沉积模式并确定输送效率。
所有模型的平均输送效率均为 86.57±14.23%。在所有情况下,模型之间的总输送效率均无显著差异。然而,基于模型和后续给药,局部沉积模式发生了改变。此外,从 MAD Nasal™装置上取下泡沫尖端以研究插入长度的影响,并未显著提高在两个测试模型(5 个月和 16 个月)中的效率。
将鼻腔复制品纳入测试中为确定常见鼻腔疫苗输送组合产品的效率提供了基准。该平台可用于比较其他潜在的鼻腔疫苗输送设备。