Preparation and characterization of isosorbide 5-mononitrate extended-release tablets

The objective of this study was to prepare isosorbide 5-mononitrate tablets with an extended-release base using paraffin wax. The goal was to develop a tablet formulation equivalent to the commercially available Imdur^? Long Acting Tablet 60?mg. We investigated the effect of paraffin wax on the dissolution rate of isosorbide 5-mononitrate and performed an in vitro dissolution test using the paddle method. The paddle stirring rates were varied from 50 to 150?rpm to mimic pre- and postprandial conditions and determine the effect of food uptake affects on drug absorption. In the dissolution study, isosorbide 5-mononitrate tablets with paraffin wax exhibited extended-release behaviors from 72 to 90?% over an 8-h period, of which the #4 formulation (110-mg paraffin wax) was comparable to the Imdur^? Long Acting Tablet 60?mg. From the f ₂ factor, the paddle stirring rate did not affect the dissolution both pH 1.2 and 6.8 between the formulation #4 and Imdur^? Long Acting Tablet 60?mg for 10?h. The results suggest that the properties of oral extended-release tablet of isosorbide 5-mononitrate containing paraffin wax were comparable to those of the Imdur^? Long Acting Tablet 60?mg, and satisfied the guidelines of the Korea Food and Drug Administration.