• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.521-527
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• 2004

Cimetidine is a histamine $H_2-receptor$ antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer, pathologic GI hypersecretory conditions, and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from $0.05\;to\;5\;{\mu}g/ml$. Coefficient of variance (CV, %) for intraday and interday validation and relative error (RE, %) were less than ${\pm}15%$. Based on this analytical method, the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). Twenty-four healthy volunteers, $21.38{\pm}1.86$ years in age and $68.71{\pm}8.68\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine, blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$ and $C_{max}$ were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in $AUC_t$ and $C_{max}$ between the two tablets were 4.17 % and 0.97% respectively. At 90% confidence intervals, the differences in these parameters were also within ${\pm}20%$. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.11 no.7
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• pp.2451-2458
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• 2010

We prepared sustained release matrix system which contains carvedilol with Compritol 888 ATO used as lipophilic sustained release excipient and hydroxypropyl methyl cellulose (HPMC) or polyethylene oxide (PEO) used as hydrophilic sustained release polymer. Wet granulation compressed method was used for preparing carvedilol sustained release matrix tablets. When carvedilol sustained release matrix tablets were prepared, we evaluated the drug release kinetics which is affected by Compritol 888 ATO ratio, a kind of hydrophilic polymer (HPMC, PEO) and hot melt coating coagglutination (HMCC) process was done. The drug release kinetics was measured for 24 hours in pH 1.2 simulated gastric fluid and pH 6.8 simulated intestinal fluid, using a dissolution tester at $37.5^{\circ}C$ in 50 rpm. Dissolution rate of controlled release matrix tablets of carvedilol was evaluated by paddle method. We confirmed that HMCC process was very effective to controlled release of drugs. The rate of Compritol 888 ATO, as a lipidic material, can control the drug release pattern about the elution rate of 95% and 24 hours delay than that of the normal tablet.

• Journal of Food Hygiene and Safety
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• v.37 no.2
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• pp.114-120
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• 2022

In this study, a comparative dissolution experiment was conducted between an immediate-release and a controlled-release vitamin C tablet applied with a technology to control the dissolution of vitamin C to maintain the vitamin C level in the human body. In order to confirm the dissolution rate (%) of vitamin C tablets, HPLC determination was conducted based on the dissolution test methods in the 'Korean Pharmacopoeia (No. 2020-88),' 'Guidelines on Specifications of Dissolution Tests for Oral dosage Forms,' and 'Standard and Specifications for Health Functional Foods (No. 2020-63)' from Ministry of Food and Drug Safety (MFDS). In addition, the dissolution pattern between the immediate-release tablet and the controlled-release tablet was comparatively analyzed. The analysis result confirmed that the immediate-release vitamin C tablet was 100% dissolved after 45 minutes, while the controlled-release vitamin C tablet was 100% dissolved after 480 minutes (8 hours). Furthermore, the dissolution rate (%) at 60 minutes was slower than that of the immediate-release vitamin C tablet. Based on these results, this study confirmed that the dissolution rate (%) test and development of controlled-release tablets containing vitamin C as the main component a re possible.

• Proceedings of the PSK Conference
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• 2004.10a
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• pp.150.1-150.1
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• 2004

• Journal of Pharmaceutical Investigation
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• v.14 no.4
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• pp.161-169
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• 1984

The tests of dissolution and bioavailability of six formulas of lorazepam tablet under various binders were performed. Lorazepam can be seperated in pharmaceutical preparation and biological plasma by high performance liquid chromatograph. Dissolution process of lorazepam tablet was largely influenced by binder and the dissolution rate was increased by sodium starch glycolate and microcrystalline cellulose, the slower dissolution rate in starch. Bioavailability of lorazepam tablet got relationship with dissolution rate, because tablets containing sodium starch glycolate and microcrystalline cellulose as binder maintained higher plasma level than other binders.

• Korean Journal of Bronchoesophagology
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• v.6 no.2
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• pp.201-203
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• 2000

The PTP (Press-Through-Pack) has been widely used as a packing material for tablets and capsules. But esophageal foreign bodies attributed to the PTP may cause injury to esophageal mucous membrane, potentially inducing severe complications such as hemorrhage, perforation, etc. We report three cases of PTP foreign bodies in esophagus with reference to recent literature.

• YAKHAK HOEJI
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• v.30 no.2
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• pp.100-103
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• 1986

The second derivative absorption spectra of acetaminophen in commercial tablet forms were measured without prior separation from other pharmaceutical adjuvants. The second derivative spectra of acetaminophen were found to have no influence on the characteristic absorbance band of it. A plot of 25 sets of the ordinate (Z) values with various acetaminophen concentrations mixed in other additives gave a straight line (correlation coefficient, 0.9999) and the slope was 2.901${\times}10^{-2}Z$ value/($\mu\textrm{g}$/ml). The procedures were sufficiently sensitive, precise and economical for the assay of tablets of acetaminophen.

• Bulletin of the Korean Chemical Society
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• v.29 no.4
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• pp.887-890
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• 2008

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.309.1-309.1
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• 2003

The purposes of this study were to evaluate bioequivalence (BE) using In-transformed pharmacokinetic parameters obtained from two risperidone products and to develop the analytical methods for the quantitative determination of risperidone in human serum. In addition, the in vitro dissolution profiles of the two risperidone products in various dissolution media: pH 1.2, 4.0, 6.8 and water (KP VII Apparatus II method) were assesed. (omitted)

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.292.1-292.1
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• 2003

Purpose. To develop a new heterodisperse 650mg acetaminophen HPMC matrix tablet with biphasic sustained release profiles. Methods. Hydroxypropylmethylcellulose(HPMC) matrix tablets were prepared by wet-granulating drug with other excipients, followed by direct compression of the dried granule mixtures into tablet using a rotary tablet machine. (omitted)