Preparation of Dexzopiclone Orally Disintegrating Tablets and Formulation Optimization
10.6039/j.issn.1001-0408.2018.01.12
- VernacularTitle:右佐匹克隆口腔崩解片的制备及处方优化
- Author:
Hui LI
1
;
Hongmei LUO
;
Qingqing TIAN
;
Shuanghua CHEN
;
Wenhan TANG
;
Yuxiang WAN
Author Information
1. 湖南中医药高等专科学校药学系
- Keywords:
Dexzopiclone;
Orally disintegrating tablets;
Formulation optimization;
Orthogonal experiment;
Disintegration time
- From:
China Pharmacy
2018;29(1):46-49
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To prepare Dexzopiclone orally disintegrating tablets (DODT),and to optimize its formulation.METHODS:Direct powder compression method was used to prepare DODT.Using repose angle of material,disintegration time and taste evaluation as indexes,single factor test was used to screen the types or amount of bulking agent,disintegrating agent,glidant and flavoring agent;using disintegration time as index,orthogonal experiment was applied to optimize the proportion of bulking agent,the amount of disintegrating agent,glidant and flavoring agent.Then the hardness and main component contents of DODT prepared by optimal formulation were determined.RESULTS:The optimal formulation was as follows as the ratio of mannitol-MCC 1 ∶ 4,the amount of disintegrating agent PVPP was 15％,the amount of glidant magnesium stearate was 1.0％,the amount of flavoring agent stevia was 3.0％.Three batches of prepared DODT were smooth in surface and good in taste;their disintegration time were(26.7 ± 1.2),(26.7 ± 0.6),(27.6 ± 0.9)s,hardness were (3.59 ± 0.19),(3.49 ± 0.18),(3.27 ± 0.16) kg,and contents were (99.47 ± 0.15) ％,(99.53 ± 0.05)％,(99.46 ± 0.20) ％,respectively (all RSDs≤0.87％,n=3).CONCLUSIONS:Prepared DODT are all in line with the quality requirements of orally disintegrating tablets.
