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Dr. Dabhi Ajay N.* and Patel Dasharath M.


Context: The present study aimed to investigate the processability of API-Hydrophilic carrier composite into Multiple unit pellet system (MUPS) formulation and therefore to reveal the benefits of the composite formation in IN-VIVO performance. Objective: Coated pellets, consisting of active layer embedded on acidic base pellets, were manufactured by wurster process in fluid bed coating. Release profile as well as IN-VIVO performance of the formulation with reference product was compared. Method: Simple and economical spray drying method was developed for the formulation of Dabigatran etexilate mesylate solid dispersion (SD). Initial characterization of pure drug, physical mixtures, reference product and solid dispersions were carried out by in vitro dissolution, dissolution efficiency, permeation study, wetting study, solubility study, FT-IR, differential scanning calorimetry (DSC) and IN-VIVO bioavailability study. Result and Discussion: DSC study showed that Dabigatran etexilate mesylate was present in its amorphous form. FT-IR study showed there is no incompatibility between any polymeric systems with drug components. Improvement in the solubility and dissolution rate was observed for all samples. During ageing study, almost no decrease of in vitro drug dissolution was observed as compare with freshly prepared solid dispersions. Solid dispersions showed more than 75% Dabigatran etexilate mesylate release after 45 min during dissolution test. Significant difference between reference product and present formulation was observed in IN-VIVO study as shows more than threefold increase in bioavailability in Rabbit plasma. Conclusion: The result showed that the wurster process of a liquid feed with hydrophilic carrier based dispersion is an attractive and promising alternative to obtain enhanced solubility and bioavailability. Thus, present study demonstrated the high potential of wurster process technique for obtaining stable solid dispersions of poorly water-soluble drugs using various solubilizing polymers.

Keywords: Multiple unit pellet system, Bioavailability, Dissolution rate, Wurster technique, Hydrophilic polymers, Differential scanning calorimetry (DSC), FT-IR.

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