（重组人）脱氧核糖核酸酶I吸入粉雾剂的处方与工艺开发
Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation.
作者信息
Zijlstra Gerrit S, Ponsioen Bart J, Hummel Sylvia A, Sanders Niek, Hinrichs Wouter L J, de Boer Anne H, Frijlink Henderik W
机构信息
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, The Netherlands.
出版信息
Pharm Dev Technol. 2009;14(4):358-68. doi: 10.1080/10837450802662820.
A formulation and process development study was performed to formulate recombinant human deoxyribonuclease I as a powder for inhalation. First, excipient compatibility (with bovine DNase as a model substance) was examined with a stability study at stressed conditions (60 and 85 degrees C) while monitoring for occurrence of the Maillard reaction. Next, powders for inhalation were prepared by spray drying and spray freeze drying. We found that spray drying with inulin as stabilizer resulted in the best powder for inhalation. Finally, an ex-vivo test with the spray dried rhDNase I/inulin powder significantly decreased elastic and viscous moduli of sputum from five cystic fibrosis patients.
进行了一项制剂和工艺开发研究，以将重组人脱氧核糖核酸酶I制成吸入用粉末。首先，以牛脱氧核糖核酸酶作为模型物质，在应力条件（60和85摄氏度）下进行稳定性研究，同时监测美拉德反应的发生，以此来检测辅料相容性。接下来，通过喷雾干燥和喷雾冷冻干燥制备吸入用粉末。我们发现，以菊粉作为稳定剂进行喷雾干燥可得到最佳的吸入用粉末。最后，对喷雾干燥的重组人脱氧核糖核酸酶I/菊粉粉末进行的体外试验显著降低了5名囊性纤维化患者痰液的弹性和粘性模量。
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