Development and Evaluation of Colon Specific Pulsatile Drug Delivery of Montelukast Sodium for Nocturnal Asthma

In the present study, colon specific, pulsatile drug delivery of Montelukast sodium was studied to achieve time and site specific controlled release of Montelukast sodium. The basic design consists of insoluble hard gelatin capsule body filled with microcapsules of Montelukast sodium and sealed with hydrogel plug. The entire Pulsatile device was enteric coated so that the variable gastric emptying can be overcome and a colon specific release can be achieved. The Montelukast sodium micro capsules were prepared and evaluated for FT-IR study, particle size, drug content, in vitro dissolution studies and from the results one better formulation was selected for further design of Pulsatile device. Hydrogel polymers in different concentrations were used as plugs to achieve suitable lag time and it was found that drug release was controlled by the concentration of polymers used. FT-IR and DSC studies showed that there were no interactions between the drug and excipients. In vitro drug release studies of pulsincap dosage forms reveals that the concentration of the polymers used in the plugs and position of plugs determines the lag time thereby affecting the drug release