Part
1
1.1
实验设备
图1 振动驱动粉末灌装系统示意图
1.2
实验材料
表1 吸入级乳糖样品物性
1.3
样品制备与处理
1.4
灌装剂量分析
Part
2
2.1
流量控制机理
2.2
灌装剂量均一性
图2 累加剂量与下料时间的关系
图3 Lactohale®100 单剂剂量分布
表2 不同样品目标剂量为5.5 mg的灌装结果
图4 气泡和阻塞现象对Respitose®ML003 单剂剂量分布的影响
2.3
振动电压对粉体平均灌装剂量的影响
2.4
振动时间对粉体平均灌装剂量的影响
Part
3
参考文献
[1]FAULHAMMER E, LLUSA M, RADEKE C, et al. The effects of material attributes on capsule fill weight and weight variability in dosator nozzle machines[J].International Journal of Pharmaceutics, 2014, 47(1/2):332–338.
[2]LLUSA M, FAULHAMMER E, BISERNI S, et al. The effects of powder compressibility, speed of capsule filling and pre-compression on plug densification[J]. International Journal of Pharmaceutics, 2014, 471(1/2): 182–188.
[3]EDWARDS D. Applications of capsule dosing techniques for use in dry powder inhalers[J]. Therapeutic Delivery,2010, 1(1): 195–201.
[4]STEGEMANN S, KOPP S, BORCHARD G, et al.Developing and advancing dry powder inhalation towards enhanced therapeutics[J]. European Journal of Pharmaceutical Sciences, 2013, 48(1/2): 181–194.
[5]DANIHER D I, ZHU J. Dry powder platform for pulmonary drug delivery[J]. Particuology, 2008, 6(4):225–238.
[6]PODCZECK F. The development of an instrumented tampfilling capsule machine I: Instrumentation of a Bosch GKF 400S machine and feasibility study[J]. European Journal of Pharmaceutical Sciences, 2000, 10(4): 267–274.
[7]PODCZECK F, NEWTON J M. Powder filling into hard gelatine capsules on a tamp filling machine[J].International Journal of Pharmaceutics, 1999, 185(2):237–254.
[8]NEWTON J M. Filling hard gelatin capsules by the dosator nozzle system--is it possible to predict where the powder goes? [J]. International Journal of Pharmaceutics, 2012,425(1/2): 73–74.
[9]LU X, YANG S, ChEN L, et al. Dry powder microfeeding system for solid freeform fabrication[C]//International Solid Freeform Fabrication Symposium, 2006: 636-643.
[10]BESENHARD M O, KARKALA S K, FAULHAMMER E, et al. Continuous feeding of low-dose APIs via periodic micro dosing[J]. International Journal of Pharmaceutics,2016, 509(1/2): 123–134.
[11]LI Z Q, YANG S F. Nanobiomaterials library synthesis for high-throughput screening using a dry powder printing method[J]. Nano Life, 2012, 2(1): 1250006.
[12]MATSUSAKA S, URAKAWA M, MASUDA H. Microfeeding of fine powders using a capillary tube with ultrasonic vibration[J]. Advanced Powder Technology,1995, 6(4): 283–293.
[13]LU X S, YANG S F, EVANS J R G. Studies on ultrasonic microfeeding of fine powders[J]. Journal of Physics D:
[14]Applied Physics, 2006, 39(11): 2444–2453.BESENHARD M O, FAULHAMMER E, FATHOLLAHI S, et al. Accuracy of micro powder dosing via a vibratory sieve-chute system[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2015, 94: 264–272.
[15]CHEN X L, SEYFANG K, STECKEL H. Development of a micro dosing system for fine powder using a vibrating capillary. Part 1: the investigation of factors influencing on the dosing performance[J]. International Journal of Pharmaceutics, 2012, 433(1/2): 34–41.
[16]CHEN X L, SEYFANG K, STECKEL H. Development of a micro-dosing system for fine powder using a vibrating capillary. Part 2: the implementation of a process analytical technology tool in a closed-loop dosing system[J].International Journal of Pharmaceutics, 2012, 433(1/2):42–50.
[17]SCHULZE D. Powders and bulk solids: Behavior,characterization, storage and flow[M]. Berlin: SpringerVerlag, 2008.
[18]FAULHAMMER E, FINK M, LLUSA M, et al. Low-dose capsule filling of inhalation products: Critical material attributes and process parameters[J]. International Journal of Pharmaceutics, 2014, 473(1/2): 617–626.
[19]HENDRICKS C D. Charging macroscopic particles[M]//MOORE A D. Electrostatics and Its Applications. New York: John Wiley and Sons, 1973.
[20]FENG J Q, HAYS D A. Relative importance of electrostatic forces on powder particles[J]. Powder Technolog, 2003, 135/136: 65–75.
[21]MATSUSAKA S, KOBAYAKAWA M, MIZUTANI M, et al. Bubbling behavior of a fluidized bed of fine particles caused by vibration-induced air inflow[J]. Scientific Reports, 2013, 3: 1190.
撰稿人 | 刘环、陈岚、李宗齐、陈东浩 上海理工大学学报
责任编辑 | 胡静
审核人 | 何发
2024-09-02
2024-09-04
2024-09-23
2024-08-28
2024-09-27
2024-08-27
2024-09-09
近年来,RNA疗法及其在疾病治疗中的潜力备受关注,今年诺贝尔生理学或医学奖授予微小RNA(microRNA)领域的研究更是将这一热度推向高峰。在新药研发蓬勃发展的今天,小核酸药物被视为继小分子药和抗体药之后的“第三次制药浪潮”的关键力量。
作者:崔芳菲
评论
加载更多