Katsarov Plamen D, Pilicheva Bissera A, Manev Hristo M, Lukova Paolina K, Kassarova Margarita I
Department of Pharmaceutical Sciences, Faculty of Pharmacy, Medical University of Plovdiv, Plovdiv, Bulgaria
High-technological Center of Emergency Medicine, Plovdiv, Bulgaria
Folia Med (Plovdiv). 2017 Sep 1;59(3):310-317. doi: 10.1515/folmed-2017-0037.
Generally, the preparation of spray-dried microspheres is strongly affected by the process parameters. Particle size and production yield are mainly influenced by the spraying solution concentration and the pump rate of the spray dryer.
The aim of this study was to assess optimum spray drying parameters - polymer concentration and pump rate required for the production of chitosan microspheres with high production yield and targeted for nasal administration particle size.
Full 32 factorial design was used to study the investigated parameters. Three different concentrations of the chitosan solution were selected: a low concentration of 1%, average concentration of 1.5% and high concentration of 2%. The rate of the peristaltic pump was also varied at three levels: low rate of 10%, medium rate of 14% and high rate of 18%.
Nine models of chitosan microspheres were formulated and characterized in terms of shape, surface morphology, size, particle size distribution and production yield. The particles obtained from 2% chitosan solutions, sprayed at 10% pump rate were of the highest yield (64.33%) and appropriate for nasal administration median diameter (3,434 μm).
The two investigated spray-drying parameters interact with each other and their influence on the production yield and the size of the chitosan microspheres should be evaluated together, instead of one at a time. The assessed process parameters allow the production of chitosan microparticles with high yield and desirable characteristics (size, size distribution and shape) for intranasal delivery.
一般来说，喷雾干燥微球的制备受到工艺参数的强烈影响。粒径和产率主要受喷雾溶液浓度和喷雾干燥器的泵速影响。
本研究的目的是评估最佳喷雾干燥参数——聚合物浓度和泵速，以高产率生产用于鼻腔给药且粒径符合要求的壳聚糖微球。
采用全32析因设计来研究相关参数。选择了三种不同浓度的壳聚糖溶液：低浓度1%、平均浓度1.5%和高浓度2%。蠕动泵的速率也在三个水平上变化：低速率10%、中速率14%和高速率18%。
制备了九种壳聚糖微球模型，并对其形状、表面形态、尺寸、粒径分布和产率进行了表征。以10%的泵速喷雾2%壳聚糖溶液得到的颗粒产率最高（64.33%），且中位直径适合鼻腔给药（3434μm）。
所研究的两个喷雾干燥参数相互影响，应同时评估它们对壳聚糖微球产率和尺寸的影响，而不是逐一评估。所评估的工艺参数能够高产率地生产出具有理想特性（尺寸、尺寸分布和形状）的用于鼻内给药的壳聚糖微粒。
