FORMULATION DEVELOPMENT AND EVALUATION OF EFAVIRENZ AND LAMIVUDINE IMMEDIATE RELEASE TABLETS: A COMBINATION THERAPY

The present study outlines a systematic approach for Formulation and Evaluation of Immediate release Tablets of lamivudine and Efavirenz. The objective of this regimen is, to delay disease progression, to increase the duration of survival by achieving maximal and prolonged suppression of HIV replication, to restore and preserve immunological function. Combination therapy is more effective and has less chances of developing resistance than monotherapy. To achieve this goal various prototype formulation trials were taken and evaluated with respect to the various quality control tests such as Thickness, hardness, weight variation, dissolution, disintegration, hardness and assay. The formula was finalized by comparing the Invitro dissolution profile with that of the Marketed Tablets. The invitro release study was performed in 2%SLS in purified water upto30 min. Among all the formulations, formulation F5 release profile was good as compared to the marketed products. Stability studies (40±2oC/75±5%RH) for 2 months indicated that no characteristics changes in formulation. There was no chemical interaction between drug and excipients.