BigPatents India

This invention relates to the method of development of convexo-flat bilayered buccal tablets which sungly fit in the buccal cavity offering uni-directional release of the non-steroidal anti-inflammatory drug Diclofenac potassium. The delivery system consists of (a) a ‘quick-release’ layer and (b) a ‘sustained-release’ layer. Administration through the buccal mucosa has several advantages such as protection of the drug from acidic and alkaline pH and enzymes of the g.i. tract and from intestinal microbial flora, avoidance of gastric irritation, avoidance of first hepatic pass of the drug and rapid blood level concentrations of the drug. The convexo-flat tablet developed consists of the mucoadhesive on the convex surface and an impermeable coating on all sides of the tablet. The delivery system has been formulated with mucoadhesive polymers, diluents, binders lubricants, preservatives, colour and pH controllers and prepared using a 16-station Drycota type machine with 11mm punch-die sets. The tablets have been evaluated in vitro for mucoadhesion using the Microprocessor Force Gauge. The tablets have been evaluated both in vitro and in vivo. The bioavailability in healthy human subjects was found to be 1.5 to 2 times for buccal administration as compared to oral tablets. Drawing Sheets. 03 Total Pages: 19 (FIG.- NIL)