RELEASE MODULATED DELIVERY OF DIGESTIVE ENZYME SUPPLEMENT

Abstract

A combination of proteolytic enzyme pepsin with amylolytic α- amylase serves as an ideal digestive enzyme supplement for the treatment of functional dyspepsia and exocrine pancreatic insufficiency. In the present research work, an attempt was made to develop a release modulated formulation which ensures the enteric delivery of acid liable α- amylase and stomach-specific delivery of pepsin using inlay tablet technology. Eight formulations of inner core layer containing α- amylase (fungal diastase) i.e., F1 to F8, were developed using varying ratios of microcrystalline cellulose and mannitol. The best suit formulation of inner core tablet was chosen and subjected to enteric coating using coating solutions C1 to C6 and evaluated for intactness of enteric coat. The formulations containing pepsin for immediate release outer coat i.e., P1 to P4, were formulated using mannitol, dicalcium phosphate, lactose and calcium carbonate, respectively, and evaluated for pharmaceutical parameters. The inlay tablet was formulated by coating best fit outer coat formulation on enteric coated inner core tablet using compression coating technique. The results of in vitro evaluation studies for formulated inlay tablet revealed that the prepared formulation releases pepsin in stomach, immediately followed by the release of α- amylase in alkaline environment of intestine.