Preparation and Stability of Mirtazapine Orally Disintegrating Tablets / 中国药师
China Pharmacist
;
(12): 610-612, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-447312
ABSTRACT
Objective:
To optimize the formula of mirtazapine orally disintegrating tablets by orthogonal experiment and determine the stability preliminarily.Methods:
The formula was optimized by orthogonal experiment based on 4 impacting factorsthe amount of mannotil (A), microcrystalline mellulose (B), low substituted hydroxypropyl cellulose (C) and cross-linked polyvinylpyrrolidone ( D) , respectively with 2 indices of disintegration time and dissolution. The release rate of the orally disintegrating tablets and the ref-erence tablets was studied by similarity factors. The stability was respectively studied by high temperature test, high humidity test and photostability test.Results:
The optimum formula of the tablets was as followsthe amount of A, B, C and D was 70, 20, 2. 5 and 10 mg, respectively. The f2 for the orally disintegrating tablets and the reference tablets in the dissolution medium was 63. 38. Conclu-sionThe formula is reasonable, the preparation process is feasible and the quality is stable.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2014
Type:
Article
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