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Seoul, South Korea

Kim Y.-H.,Kolon Pharmaceuticals Inc. | Choi K.-S.,Kolon Pharmaceuticals Inc. | Kam S.-H.,Kolon Pharmaceuticals Inc. | Lee K.-H.,Kolon Pharmaceuticals Inc. | Park J.-S.,Chungnam National University
Arzneimittel-Forschung/Drug Research | Year: 2012

Background: The purpose of the present study was to test a sustained release-tablet newly formulated with synthetic paraffin and compare its bioequivalence to that of the Imdur® Long-Acting tablet, based on the guidelines of the Korean Food and Drug Administration. Methods: Dissolution test was performed in 4 different dissolution media. A LC/MS/MS method of isosorbide 5-mononitrate in human plasma was validated. In vivo bioequivalence tests of the 2 isosorbide 5-mononitrate tablets were performed in both preprandial and postprandial states. Results: A comparative dissolution test gave similar results for both tablets in all dissolution media tested: 40% dissolution in pH 1.2 at 2h and 80% dissolution in pH 4.0, pH 6.8, or water at 10h. In a bioequivalence study to compare 2 tablets, the mean total area under the curve (AUCt) and peak concentration (Cmax) in the fasted state were 8476.0ng·h/mL and 540.4ng/mL, respectively, for the Imdur® Long Acting Tablet 60mg, and 8701.4ng·h/mL and 564.2ng/mL, respectively, for the test tablet. The mean AUCt and Cmax in the fed state were 8793.5ng·h/mL and 559.9ng/mL, respectively, for the Imdur® Long-Acting tablet 60mg, and 8639.8ng·h/mL and 617.9ng/mL, respectively, for the test tablet. The 90% confidence intervals using log transformed data were within the acceptable range of 0.81.25. Conclusion: Based on these statistical analyses, we conclude that the test tablet is bioequivalent to the Imdur® Long-Acting tablet 60mg in both the preprandial and postprandial states. © Georg Thieme Verlag KG Stuttgart New York. Source


Kim Y.-H.,Chungnam National University | Kim Y.-H.,Kolon Pharmaceuticals Inc. | Choi K.S.,Kolon Pharmaceuticals Inc. | Lee K.-H.,Kolon Pharmaceuticals Inc. | Park J.-S.,Chungnam National University
Journal of Pharmaceutical Investigation | Year: 2012

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 f2 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. © 2012 The Korean Society of Pharmaceutical Sciences and Technology. Source

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