Focaroli Stefano, Jiang Guannan, O'Connell Peter, Fahy John V, Healy Anne-Marie
School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, Dublin 2 D02, Ireland.
Division of Pulmonary and Critical Care Medicine, Department of Medicine and Cardiovascular Research Institute, Health Sciences East, UCSF, 513 Parnassus Avenue, San Francisco, CA 94143, USA.
Pharmaceutics. 2020 Nov 20;12(11):1116. doi: 10.3390/pharmaceutics12111116.
The aim of this study was to investigate the use of a three-fluid atomising nozzle in a lab-scale spray dryer for the production of dry powders intended for pulmonary delivery. Powders were composed of salbutamol sulphate and theophylline in different weight ratios. The three-fluid nozzle technology enabled powders containing a high theophylline content to be obtained, overcoming the problems associated with its relatively low solubility, by pumping two separate feed solutions (containing the two different active pharmaceutical ingredients (APIs)) into the spray dryer via two separate nozzle channels at different feed rates. The final spray-dried products were characterized in terms of morphology, solid-state properties and aerosolization performance, and were compared with an equivalent formulation prepared using a standard two-fluid atomising nozzle. Results confirmed that most of the powders made using the three-fluid atomising nozzle met the required standards for a dry powder inhaler formulation in terms of physical characteristics; however, aerosolization characteristics require improvement if the powders are to be considered suitable for pulmonary delivery.
本研究的目的是在实验室规模的喷雾干燥器中研究使用三流体雾化喷嘴来生产用于肺部给药的干粉。粉末由不同重量比的硫酸沙丁胺醇和茶碱组成。通过以不同的进料速率将两种单独的进料溶液(含有两种不同的活性药物成分(API))通过两个单独的喷嘴通道泵入喷雾干燥器,三流体喷嘴技术能够获得含有高茶碱含量的粉末,克服了与其相对较低的溶解度相关的问题。对最终喷雾干燥产品的形态、固态性质和气溶胶化性能进行了表征,并与使用标准双流体雾化喷嘴制备的等效制剂进行了比较。结果证实,使用三流体雾化喷嘴制备的大多数粉末在物理特性方面符合干粉吸入剂制剂的要求标准;然而,如果要认为这些粉末适合肺部给药,则气溶胶化特性需要改进。