Foo Mow Yee, Cheng Yung-Sung, Su Wei-Chung, Donovan Maureen D
University of Iowa, College of Pharmacy Iowa City, Iowa, IA 52242, USA.
J Aerosol Med. 2007 Winter;20(4):495-508. doi: 10.1089/jam.2007.0638.
While numerous devices, formulations, and spray characteristics have been shown to influence nasal deposition efficiency, few studies have attempted to identify which of these interacting factors plays the greatest role in nasal spray deposition. The deposition patterns of solutions with a wide range of surface tensions and viscosities were measured using an MRI-derived nasal cavity replica. The resulting spray plumes had angles between 29 degrees and 80 degrees and contained droplet sizes (D(v50)) from 37-157 microm. Each formulation contained rhodamine 590 as a fluorescent marker for detection. Administration angles of 30 degrees , 40 degrees , or 50 degrees above horizontal were tested to investigate the role of user technique on nasal deposition. The amount of spray deposited within specific regions of the nasal cavity was determined by disassembling the replica and measuring the amount of rhodamine retained in each section. Most of the spray droplets were deposited onto the anterior region of the model, but sprays with small plume angles were capable of reaching the turbinate region with deposition efficiencies approaching 90%. Minimal dependence on droplet size, viscosity, or device was observed. Changes in inspiratory flow rate (0-60 L/min) had no significant effect on turbinate deposition efficiency. Both plume angle and administration angle were found to be important factors in determining deposition efficiency. For administration angles of 40 degrees or 50 degrees , maximal turbinate deposition efficiency (30-50%) occurred with plume angles of 55-65 degrees , whereas a 30 degrees administration angle gave an approximately 75% deposition efficiency for similar plume angles. Deposition efficiencies of approximately 90% could be achieved with plume angles <30 degrees using 30 degrees administration angles. Both the plume angle and administration angle are critical factors in determining deposition efficiency, while many other spray parameters, including particle size, have relatively minor influences on deposition within the nasal cavity.
虽然已有众多装置、制剂和喷雾特性被证明会影响鼻腔沉积效率,但很少有研究试图确定这些相互作用的因素中哪一个在鼻喷雾剂沉积中起最大作用。使用磁共振成像衍生的鼻腔模型测量了具有广泛表面张力和粘度的溶液的沉积模式。所得喷雾羽流的角度在29度至80度之间,液滴尺寸(D(v50))为37 - 157微米。每种制剂都含有罗丹明590作为用于检测的荧光标记物。测试了水平上方30度、40度或50度的给药角度,以研究使用者技术对鼻腔沉积的作用。通过拆解模型并测量每个部分中保留的罗丹明量来确定鼻腔特定区域内沉积的喷雾量。大多数喷雾液滴沉积在模型的前部区域,但羽流角度小的喷雾剂能够到达鼻甲区域,沉积效率接近90%。观察到对液滴尺寸、粘度或装置的依赖性最小。吸气流量(0 - 60升/分钟)的变化对鼻甲沉积效率没有显著影响。发现羽流角度和给药角度都是决定沉积效率的重要因素。对于40度或50度的给药角度,当羽流角度为55 - 65度时,鼻甲最大沉积效率(30 - 50%)出现,而对于类似的羽流角度,30度的给药角度给出约75%的沉积效率。使用30度给药角度,当羽流角度<30度时,沉积效率可达到约90%。羽流角度和给药角度都是决定沉积效率的关键因素,而许多其他喷雾参数,包括粒径,对鼻腔内的沉积影响相对较小。