FABRICATION AND EVALUATION OF ORAL CONTROLLED RELEASE OF MUCOADHESIVE ALGINATE MICROBEADS CONTAINING FLUVASTATIN SODIUM
Objective: The aim of this study is to prepare oral controlled release of mucoadhesive alginate microbeads encapsulating fluvastatin by gastro retention technology.
Methods: The mucoadhesive microbeads containing fluvastatin were produced by using emulsification internal gelation technique. The effect of different variables like sodium alginate concentration and its combination with other hydrophilic polymers, the effect of various curing agents on particle size, entrapment efficiency and in-vitro studies were evaluated.
Results: There was no marked change in drug entrapment efficiency, and dissolution studies occurs during the stability studies of fluvastatin. The in-vitro results gives data that improvement in the controlled release of the drug from microbeads compared with marketed tablet. So in this regards, to minimize the frequency of drug administration to reduce side effects. The optimum condition for preparation of stable alginate beads and produce controlled release manner was occurs at higher concentration of combined polymer mixture in equal ratios i.e 3% w/v. Infrared spectroscopic study (FTIR) confirmed the no incompatibility between drug and other excipients. X-ray diffraction study (XRD) and differential scanning colorymetry (DSC) were provide evidence that successful entrapment of drug into the alginates microbeads and drug converted into amorphous nature. The efficiency of mucoadhesion strength of microbeads determined by wash-off study
Conclusion: The kinetic modeling of the release data indicates drug release from the microbeads follow anomalous transport mechanism and super case-II transport mechanism. Drug release is function of pH dependent and controlled drug release depends upon type and concentration of polymer blend and curing agents. The release kinetics of drug from the alginate beads followed zero order.
Keywords: Fluvastatin, Emulsification internal gelation, Sodium alginate, HPMC 50cps, In-vitro wash off study and Swelling index.
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