ORAL BIOAVAILABILITY ENHANCEMEMENT OF BROMOCRYPTINE MESYLATE BY SELF-MICRO EMULSIFYING DRUG DELIVERY SYSTEM (SMEDDS)
Keywords:
Bromocryptine Mesylate, Nil, Self Microemulsifying Drug Delivery System, Bioavailability, Pharmacodynamic studyAbstract
Objective: The purpose of this work was to enhance oral bioavailability of Bromocryptine Mesylate by preparing SMEDDS (self-micro emulsifying drug delivery system)
Methods: Screening of oils, surfactants and co-surfactants were done by solubility study & pseudo ternary diagram. The batches of Bromocryptine Mesylate (BM)–SMEDDS were prepared and evaluated for droplet size analysis, poly dispensability index (PDI), robustness to dilution, zeta potential, in vitro dissolution. The optimized batch was compared with commercially available quick release tablets of BM (Brainstar®, 0.8 mg/tablet) by in vivo study (Pharmacodynamic study in rats).
Results: Based on the drug's solubility study, Akoline MCM, Tween80 and PEG400 were selected as oil, surfactant and co-surfactant, respectively. By pseudo ternary diagram, the components' ratios were screened. In vitro drug release of the optimized batch was lower than the commercial preparation but in in vivo study, optimized batch was similar with commercial tablets.
Conclusion: From the study, it was concluded that the group treated with optimized BM-SMEDDS showed better and sustained reduction in blood sugar as compared to control group and the group treated with marketed formulation, indicated improvement in bioavailability of drug.
Keywords: Bromocryptine Mesylate, Type–II Diabetes, Self micro emulsifying drug delivery system, Bioavailability, Pharmacodynamic study
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