FORMULATION DEVELOPMENT AND EVALUATION OF IMMEDIATE RELEASE ANTI-COAGULANT DRUG RIVAROXABAN FILM COATED TABLETS

Author(s): M. Sunitha Reddy* and M. Himavarsha

Abstract: The aim of the present study is to develop immediate release tablets of Rivaroxaban, to enhance solubility and dissolution for increasing its oral bioavailability. Rivaroxaban is widely prescribed as anti-coagulant drug which belongs to BCS class II.In present study, DOE trails was applied in the study by using solubilizing agent (SLS), Binding agent (HPMC), super disintegrant (CCS). Pre-compression studies were performed in formulation suggested by software and results were found to be within limits. The formulation were compressed by wet granulation method & evaluation tests were weight variation, hardness, friability, drug content, in-vitro drug release studies were performed. The cumulative drug release from all the formulations were compared with that of the Innovator. The enhanced Rivaroxaban release was by using 0.4 % SLS solution in dissolution media. Formulation trail F8 containing, Croscarmellose sodium(5.6mg), Hydroxy propyl methyl cellulose(4.0mg), Sodium Lauryl Sulphate(0.4mg) was selected as an optimized formulation as it showed same dissolution profile as innovator. It also matched the multimedia dissolution profile with the innovator.

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