Development of Nanocrystal Ziprasidone Orally Disintegrating Tablets: Optimization by Using Design of Experiment and In Vitro Evaluation

被引：12
作者：
Tashan, Emine [1 ,2 ]
Karakucuk, Alptug [1 ]
Celebi, Nevin [1 ]
机构：
[1] Gazi Univ, Fac Pharm, Dept Pharmaceut Technol, Ankara, Turkey
[2] Zoleant Pharmaceut Int, Istanbul, Turkey
来源：
AAPS PHARMSCITECH | 2020年 / 21卷 / 03期
关键词：
nanocrystal(s); oral drug delivery; factorial design; dissolution; physical characterization; FORMULATION DEVELOPMENT; DISSOLUTION RATE; NANOSUSPENSIONS; OLANZAPINE; QUALITY; BIOAVAILABILITY; ANTIPSYCHOTICS; SCHIZOPHRENIA; RISPERIDONE; MANAGEMENT;
D O I：
10.1208/s12249-020-01653-9
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The objective of the current study was to develop ziprasidone hydrochloride monohydrate (ZHM) nanocrystal-based orally dispersible tablet (ODT) formulations. Design of experiment approach was used to develop ODTs. The tablets were compressed using direct compression method and characterized with quality control tests. In vitro dissolution studies and Caco-2 cell permeability tests were executed. The hardness and friability values of nanocrystal-based ODTs were found 31.2 N and 1.05%, respectively. The disintegration time was below 10 s. Dissolution profile in pH 7.4 phosphate buffer showed that nanocrystal-based ODTs and commercial product were dissolved in 120 min 58.98% and 16%, respectively. In pH 7.4 phosphate buffer with SLS, sample groups dissolved above 85% at the end of the study. Permeability value and cumulative ZHM amount on the cells were improved with nanocrystals. In conclusion, the novel formulation of ZHM nanocrystal-based ODTs was successfully developed for alternative dosage form.
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收藏
页数：12
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