期刊
ACTA PHARMACEUTICA SINICA B
卷 4, 期 1, 页码 79-85出版社
INST MATERIA MEDICA, CHINESE ACAD MEDICAL SCIENCES
DOI: 10.1016/j.apsb.2013.12.010
关键词
R-salbutamol; Nebulizer; NGI; Particle size; Dose uniformity; Guinea pigs; Asthma
资金
- Key-Pharma Biomedical Inc. Dongguan, China
- small and mid-sized enterprise technology innovation fund management center of Science and Technology Department [10C26214404752]
An aerosol formulation containing 7.5 mg of R-salbutamol sulfate was developed. The aerosol was nebulized with an air-jet nebulizer, and further assessed according to the new European Medicines Agency (EMA) guidelines. A breath simulator was used for studies of delivery rate and total amount of the active ingredient at volume of 3 mL. A next generation impactor (NGI) with a cooler was used for analysis of the particle size and in vitro lung deposition rate of the active ingredient at 5 degrees C. The antiasthmatic efficacy of the aerosol formulation was assessed in guinea pigs with asthma evoked by intravenous injection of histamine compared with racemic salbutamol. Our results show that this aerosol formulation of R-salbutamol sulfate met all the requirements of the new EMA guidelines for nebulizer. The efficacy of a half-dose of R-salbutamol equaled that of a normal dose of racemic salbutamol. (C) 2014 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences.
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