Preparation and Quality Study of Lipoic Acid Orally Disintegrating Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare Lipoic acid orally disintegrating tablets,and to evaluate its quality. METHODS:Lipoic acid orally disintegrating tablets were prepared with direct compression after wet granulation. With disintegration time and dissolu-tion as index,the constituents of disintegrating agent,filler and lubricant were screened by single factor test combined with orthogo-nal test. The tablet weight,hardness,disintegration time,accumulative rate and percentage content were investigated. RESULTS:The optimal formulation was MCC 167.58 mg,L-HPC 23.94 mg,PVPP 47.88 mg,mannitol 60 mg,lipoic acid 300 mg and mag-nesium stearate 0.6 mg. The parameters of prepared disintegrating tablets was as follows as (0.59 ± 0.05) g in weight,(20.32 ± 0.16)kg in solidity and(23.5±0.4)s in disintegration time,101.49% in 3 min accumulative dissolution rate,96.34% of labeled content. CONCLUSIONS:Lipoic acid orally disintegrating tablets are prepared successfully and controllable in quality.