DEVELOPMENT AND EVALUATION OF ORAL CONTROLLED RELEASE MATRIX TABLETS OF LAMIVUDINE: OPTIMIZATION AND IN VITRO-IN VIVO STUDIES
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 1
Abstract
Objectives: To develop and evaluate a controlled release matrix tablets containing lamivudine (LAM).Methods: A central composite design (CCD) of the experiment were employed with the amount of hydrophilic polymer (HPMC K100M) (X1) and amount of hydrophobic polymer cellulose acetate phthalate (X2) as independent variables. Four response variables were considered in the formulation, which includes the % drug release at 1hr (Y1), % drug release at 8hr (Y2), diffusion coefficient (Y3) and T50% (Y4). The design was quantitatively evaluated by the quadratic model.Results: Statistical analysis revealed that factor X1 was found to be highly significant for responses Y2 and Y4, whereas factor X2 for response Y1. The quadratic factor of X1 and X2 is found to be highly significant in response Y3. A numerical optimization technique for desirability function was used to optimize the response variables with different target and the observed responses were highly agreed with experimental values. The response Y1-Y4 and the optimized formulation was arrived by restricting to 17% < Y1 > 18%; 72.0% < Y2 > 75%; 0.55 < Y3 > 0.65; 4.2 < Y4 > 4.52h. The results showed a good relationship between the experimented and predicted values. The dissolution profiles of the optimal formulation before and after stability studies were evaluated by using a similarity factor (Æ’2) and were found to be similar. In vivo studies indicate that the formula generated by CCD showed a controlled release profile.Conclusion: The results of in vivo studies revealed that the optimized formulation exhibited a controlled release of lamivudine.Â
Authors and Affiliations
Nelson Kenneth, Varadarajan Parthasarathy, Chikkanna Narendra, Prakasam Kalyani
Keywords
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