Zhang Rui, Hu Junhua, Deng Liangjun, Li Sha, Chen Xi, Liu Fei, Wang Shanping, Mohammed Abdul Khaja Shameem, Beng Huimin, Tan Wen
Institute of Biomedical and Pharmaceutical Sciences, Guangdong University of Technology, Guangzhou 510006, Guangdong, China.
School of Bioscience and Bioengineering, South China University of Technology, Guangzhou 510006, Guangdong, China.
Pharmaceutics. 2020 Jan 17;12(1):78. doi: 10.3390/pharmaceutics12010078.
Inhalation therapy with a nebulizer is widely used in chronic respiratory disease. Mixing inhalation solutions/suspensions for simultaneous inhalation is more convenient and might simplify the administration procedure. However, there are no data available to address the in vitro aerosol characteristics and physico-chemical compatibility of Combivent (containing Salbutamol and Ipratropium bromide) with other inhalation solutions/suspensions. In order to investigate the in vitro aerosol characteristics and physico-chemical compatibility of Combivent with Budesonide, Beclomethasone, and -acetylcysteine, the appearance, pH, osmotic pressure, chemical stability, mass median aerodynamic diameter (MMAD), fine particles fraction (FPF), particle size corresponding to X50 (particle size, which accounts for 50% of the total cumulative percentage of volume of all particles), delivery rate, and total delivery of the mixed inhalation solution/suspension were tested. There was no change in the appearance such as a change in color or precipitation formation at room temperature. The pH, osmolality, and chemicals of the mixtures were stable for 24 h after mixing. There were no significant differences between Combivent, Budesonide, Beclomethasone, -acetylcysteine, and the mixtures in MMAD, FPF, X50, the delivery rate, and the total delivery. This indicates that the mixtures were physically and chemically compatible. The mixing did not influence the particle size, distribution, or delivery compatibility of the mixtures.
使用雾化器进行吸入治疗在慢性呼吸道疾病中广泛应用。将吸入溶液/混悬液混合以同时吸入更为便捷，且可能简化给药程序。然而，尚无数据可用于说明可必特（含沙丁胺醇和异丙托溴铵）与其他吸入溶液/混悬液的体外气溶胶特性及物理化学相容性。为研究可必特与布地奈德、倍氯米松和N - 乙酰半胱氨酸的体外气溶胶特性及物理化学相容性，对混合吸入溶液/混悬液的外观、pH值、渗透压、化学稳定性、质量中值空气动力学直径（MMAD）、细颗粒分数（FPF）、对应X50的粒径（占所有颗粒总体积累积百分比50%的粒径）、递送速率及总递送量进行了测试。室温下外观无变化，如颜色改变或沉淀形成。混合后混合物的pH值、渗透压及化学成分在24小时内保持稳定。可必特、布地奈德、倍氯米松、N - 乙酰半胱氨酸及混合物在MMAD、FPF、X50、递送速率及总递送量方面无显著差异。这表明混合物在物理和化学上是相容的。混合未影响混合物的粒径、分布或递送相容性。
