Kolon Pharmaceuticals Inc.

Seoul, South Korea

Kolon Pharmaceuticals Inc.

Seoul, South Korea
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Lee M.-J.,Inje University | Park C.-R.,Inje University | Kim A.-Y.,Inje University | Kwon B.-S.,Kolon Pharmaceuticals Inc. | And 4 more authors.
Journal of Pharmaceutical Sciences | Year: 2010

NIR spectroscopy has been extensively employed for the in-line monitoring of pharmaceutical processes as one of the key PAT implementation tools. Nevertheless, pharmaceutical processes such as fluid-bed coating have not fully made the most of the NIR in-line monitoring primarily due to a difficulty in handling random in-line spectra. In this study, novel approaches to develop a reasonable dynamic calibration model were proposed; averaging and clustering. Pharmaceutical test tablets were coated with HPMC-based materials using a fluid-bed processor. During the 160 min coating process under tangential spraying mode, 10 tablets were sampled out at every 10 min mark for actual coating thickness measurements. NIR spectra at and near each 10 min mark were treated and processed by the averaging and clustering operations. Averaging of 21 spectra resulted in a reasonably good dynamic calibration model whose determination coefficient was estimated as high as 0.9916. The PCA-based clustering turned out to be substantially helpful especially when a large number of NIR spectra were averaged. A prediction experiment verified that our dynamic calibration model can control the coating thickness in-line as good as 3% deviated from the actual thickness, which can offer a reasonable end-point for the fluid-bed coating process. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association.


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.


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.

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