Formula Optimization of Bromhexine Hydrochloride Dry Powder Inhalations by Central Composite Design-response Surface Methodology
10.3969/j.issn.1008-049X.2018.06.015
- VernacularTitle:星点设计-效应面法优化盐酸溴己新吸入粉雾剂的处方
- Author:
Yinke LI
1
;
Xiaosong YANG
;
Zihao ZHOU
;
Qiongzhi SHI
;
Chen CHEN
;
Xiangru LIAO
;
Ying CHEN
;
Xiangyang XIE
Author Information
1. 解放军武汉总医院药剂科 武汉430070
- Keywords:
Bromhexine hydrochloride;
Dry powder inhalations;
Central composite design-response surface methodology;
Fine particle fraction;
Formula screening
- From:
China Pharmacist
2018;21(6):1010-1015
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To optimize the formula of bromhexine hydrochloride dry powder inhalations (BH DPIs). Methods: BH DPIs were prepared by freezing-drying combined with an air-jet milling method. Three factors, including the weights of mannitol (X1), leucine (X2) and poloxamer 188 (X3) in the formula were known to be associated with the quality of BH DPIs. A central composite design was used to investigate the effects of the three factors on the response angle (Y1), fine particle fraction (FPF, Y3) and aerody-namic diameter (Y4). Response surface and overlay contour plot were delineated according to the best-fit mathematic models. Opti-mum formula was selected by overlay contour plot. Results: The quantitative relationships between the three factors and the three re-sponses were obtained. The optimal formula was mannitol﹕leucine﹕poloxamer 188 (2. 4: 2. 22: 0. 05) in the excipients. The pre-dicted and observed values of the optimum formula were similar. Conclusion: The multi-objective simultaneous optimization of the for-mula of BH DPIs is achieved by central composite design-response surface methodology.
