Formulation and in Vitro Evaluation of Aspirin and Isosorbide 5-mono- Nitrate Sustained Bilayer Tablets

In this study, aspirin (AS) and isosorbide 5mononitrate(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. INTRODUCTION: Aspirin chemically known as acetyl salicylic acid is used as a non-steroidal antiinflammatory and analgesic drug. The structural formula of AS is as follows: QUICK RESPONSE CODE DOI: 10.13040/IJPSR.0975-8232.5(3).799-04 Article can be accessed online on: www.ijpsr.com DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.5(3).799-04 Isosorbide 5-mononitrate, chemically known as 1, 4:3, 6-dianhydroD -glucitol 5-mononitrate, is used as antianginal drug. The structural formula of ISM is as follows: A combination of AS of 75 mg and ISM of 60 mg is commercially available tablet form. This medicine contains two active ingredients, namely AS and ISM. AS is a non-steroidal antiinflammatory drug (NSAID) which is widely used for treatment of pain, fever and other inflammatory conditions 1 .