Abstract

FORMULATION AND EVALUATION OF SOLIFENACIN SUCCINATE IMMEDIATE RELEASE TABLETS USING VARIOUS SUPERDISINTEGRANTS

Hari Prasad Bhatta*1, C.Sowmya1, B. Swetha1, Amrit Khanal1, Bishnu Adhikari1, Hemraj Sharma2

ABSTRACT

Objectives: The aim of present work was to formulate and evaluate immediate release tablets of Solifenacin succinate and to achieve commercial availability of Solifenacin which has great market potential. Solifenacin succinate is an anticholinergic drugs, which is highly soluble and highly permeable (BCS Class I). Methods: The tablets were prepared by direct compression using Lactose anhydrous, HPMC E5, Sodium starch glycolate, Croscarmellose sodium and crospovidone with different concentration, Silicon colloidal dioxide as glidant and magnesium stearate as lubricants. The pre-formulation studies like XRD, FTIR & API and excipients ratio were carried out. The pre-compression parameters were evaluated for bulk density, tapped density, Carrs’s index, Hausner ratio, angle of repose and particle size analysis. The post compression parameters were evaluated for weight variation, thickness, hardness, disintegration time and friability. The in-vitro drug release studies were conducted by USP type II dissolution apparatus. Result and discussion: The pre-formulation study shown the API and excipients were compatible. All the formulation passes the accepted limited for pre-compression and post compression parameters. Among the all formulation, F9 showed the higher drug release 98.12% containing 10% crospovidone (17mg) and having less disintegration time 3 min 30 sec comparing with all formulation. Conclusion: The Solifenacin succinate immediate release tablets were prepared by the direct compression methods.

Keywords: AOB, Solifenacin succinate, superdisintegrants, direct compression and BCS class.