Abstract

FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF S (-) METOPROLOL SUCCINATE USING ROLLER COMPACTION APPROACH

Srikant Pimple*, Pravin Maurya, Akash Joshi, Mohan Salunke, Ruby Singh

ABSTRACT

Metoprolol succinate is a Beta 1-selective, adrenoceptor blocking agent used in the treatment of hypertension, angina pectoris and heart failure. S-Metoprolol at half the dose of racemate has proved to be effective in the treatment of hypertension. The present study was aimed to develop a chirally pure S (-) Metoprolol Succinate Tablets 50 mg and 25 mg equivalent to Metoprolol Tartrate Tablets 100 mg and 50 mg respectively. Preformulation studies were carried out to evaluate the compatibility of API with all the excipients used in formulation. Results of drug excipient compatibility study indicate that the API was compatible with all excipients. Immediate release tablets were prepared by both wet granulation and direct compression techniques. In wet granulation process related substance was observed on higher side. To overcome the problem of related substance further batches were taken with direct compression which results in reduction in related substance but flow properties were poor. Final formulation was prepared by direct compression technique using roller compaction approach. Roller compaction is commonly used as a dry granulation technique to produce granules with enhanced flowability, increase in bulk density and ready for die compression. Physiochemical and in-vitro release characteristics of all the formulation was evaluated and compared. Percent drug release of test formulation was compared with reference racemic drug product and similarity factor for both the strength was calculated. Accelerated stability studies were performed for 2 Months and results were found well within the limits.

Keywords: S (-) Metoprolol Succinate, Immediate release tablets, Roller compaction, Compatibility Study, Dissolution Study, Accelerated stability study