Optimization of the Formulation of Azelastine Hydrochloride Thermosensitive In-situ Gel Nasal Drops by Central Composite Design-Response Surface Methodology
10.6039/j.issn.1001-0408.2016.01.32
- VernacularTitle:星点设计-响应面法优化盐酸氮斯汀温敏型原位凝胶滴鼻剂处方
- Author:
Hongli WANG
;
Haiyan BIE
;
Chuanping SI
;
Yingting WANG
- Publication Type:Journal Article
- Keywords:
Azelastine hydrochloride;
Thermosensitive in-situ gel;
Nasal drops;
Central composite design-response surface methodology
- From:
China Pharmacy
2016;27(1):98-100
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize Azelastine hydrochloride (AH) thermosensitive in-situ gel nasal drops formulation. METHODS:Using poloxamer 407(P407)and poloxamer 188(P188)as excipients,AH thermosensitive in-situ gel was prepared by cold solution method. The formulation was optimized by central composite design-response surface methodology using the amount of P407 and P188(g/100 ml)as factors and phase-transition temperature as index. Binomial expression was fitted,and pre-dicted and measured values were compared. RESULTS:The correlation coefficient R2 fitted by binomial expression was equal to 0.986 5. The optimal formulation was as follows as P407 for 20.414 4%,P188 for 5.035 4%,measured value of(30.81±0.02)℃, predicted values of 31 ℃,deviation of 0.61%. CONCLUSIONS:AH thermosensitive in-situ gel nasal drops formulation is opti-mized by central composite design-response surface methodology.
