Formula Optimization of Memantine Hydrochloride Sustained Release Pellets by Box-Behnken Surface Response Design
- VernacularTitle:Box-Behnken效应面法优化盐酸美金刚缓释微丸处方工艺
- Author:
Jiansong WANG
;
Ying XIAO
;
Long XI
;
Sheng XING
- Keywords:
Memantine hydrochloride;
Sustained release pellets;
Orthogonal tests;
Box-Behnken surface response design
- From:
China Pharmacist
2017;20(5):837-841
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To optimize the formula of memantine hydrochloride sustained release pellets and investigate the drug release in vitro.Methods: Memantine hydrochloride sustained release pellets were prepared by a fluidized bed.The factors such as inlet air temperature, spray pressure and feeding rate were optimized by orthogonal tests.The Box-Behnken response surface methodology was used to screen the major influencing factors (ethyl cellulose aqueous dispersion, PEG 6000 and the coating weight) in the release of memantine hydrochloride.The coating formula and coating weight were optimized with the cumulative release rate of memantine hydrochloride in 2, 6,and 12 h as the response values.The drug release in vitro was also studied.Results: The optimum preparation parameters of the pellets were as follows: the inlet air temperature of 45℃, the spray pressure of 1.0 bar, and the feeding rate of 1.5 r·min-1.The best sustained release coating formula was as follows: the content of ethyl cellulose aqueous dispersion of 8.4%, the content of PEG 6000 of 2.3%, and the weight gain of sustained release layer of 16.7%.The memantine hydrochloride sustained release pellets had notable sustained release effect.Conclusion: Orthogonal tests and Box-Behnken response surface method can be used for the formula optimization of memantine hydrochloride sustained-release pellets.The established fitting model is simple with good predictability.
