FORMULATION AND IN VITRO EVALUATION OF ASPIRIN AND ISOSORBIDE 5-MONO-NITRATE SUSTAINED BILAYER TABLETSAbstract
In this study, aspirin (AS) and isosorbide 5-mononitrate(ISM) sustained bilayer tablets were developed by wet granulation and compression technique, the influence of the contents of PVPP on the dissolution of AS from the tablets was investigated. An orthogonal experiment design was used to optimize ISM sustained release layer. The tablets were tested for their drug content, hardness, thickness, friability, and in vitro release characteristics. The optimized formulation of sustained bilayer tablets contains ISM 60 mg, HPMC K100M 45 mg, CMC-Na 12 mg, HPMC K15M 12 mg, lactose 50 mg and aerosol 3 mg for sustained release layer of ISM, PVP K30 Ethanol solution was used as adhesives. The optimized formulation of sustained bilayer tablets contains AS 75mg, PVPP 10mg, citrate acid 15mg, MCC 35mg, pregelatinized starch 15mg and 2mg talc for fast release layer. The drug release of AS was above 80% at 0.5h hour and ISM was above 70% at 7h in the optimized formulation.
Liandong Hu *, Qiaofeng Hu , Dongqian Kong
School of Pharmaceutical Sciences & Key Laboratory of Pharmaceutical Quality Control of Hebei Province, Hebei University, No.180, WuSi Road, Baoding- 071002, PR China
24 October, 2013
29 November, 2013
13 February, 2014