Preparation and quality evaluation of clonazepam orally disintegrating tablets
10.3969/j.issn.1673-8225.2009.38.031
- VernacularTitle:氯硝西泮口腔崩解片的研制及质量评价
- Author:
Bingying LI
;
Xia HOU
- Publication Type:Journal Article
- From:
Chinese Journal of Tissue Engineering Research
2009;13(38):7543-7546
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To prepare clonazepam oral disintegrating tablets and to evaluate its quality. METHODS: Gelatian and aspartame were used as tastes masking. Microcrystalline celluose, low substituted hydroxypropylcellulose and polyvininylpolyrrolidone were used as disintegrants. Clonazepam orally disintegrating tablets were prepared by wet granules. The in vitro and in vivo disintegration time, the relationship between hardness and disintegration time and the relationship between the usage of magnesium stearate and disintegration time were investigated, while taste and dissolution rate were also evaluated. RESULTS: When the gelatian/aspartame/poloxamer ratio was 30:0.5:1, the tablets had good oral feel and the uppermost dissolution rate. The dissolution rate of clonazepam oral disintegrating tablets which was evaluated by the method of common tablets could exceed 95% after 20 minutes. When the microcrystalline celluose / low substituted hydroxypropylcellulose / polyvininylpolyrrolidone ratio was 9:1: 3, the in vitro and in vivo disintegration time Was within 30 s. When the usage of magnesium stearate was 0.5% and the hardness ratio was in the range of 3-4 kg, disintegration time was within 30 s. CONCLUSION: According reasonable prescription and simple product craft, we can product qualified clonazepam oral disintegrating tablets.
