• Journal of Pharmaceutical Investigation
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• v.37 no.2
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• pp.79-84
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• 2007

This study was aimed to establish analytical method of Bi to develop a guideline of the bioequivalence test of tripotassium dicitrato bismuthate (TDB). For this purpose, a simple, specific and sensitive inductively coupled plasma-mass spectrometry (ICP/MS) method were developed and validated in human plasma. Various concentrations of bismuth standard solution (0-25ng/mL) were prepared with distilled water and human blank plasma. To 10mL of the volumetric flasks, 2mL of blank plasma was added with 8ml of distilled water. Bi standard solution was added to prepare the calibration samples and injected into ICP-MS. The plasma samples obtained from volunteers given 3 tablets of bismuth (total 900mg as TDB) were analyzed as described above. As a result, the coefficients of variation were <20% in quantitation limit (0.2 ng/mL) and <15% at the rest of concentrations. The stability test by repeated freezing-thawing cycles showed that the samples were stable only for 24hr. The stability tested for samples with a short-term period of storage at room temperature and pre-treatment prior to the analysis showed very stable over 24hr. In 8 healthy Korean subjects received Denol tablets at the dose of 900mg bismuth, AUC, $C_{max},\;T_{max}$ and half-life $(t_{1/2})$ were determined to be $198.33{\pm}173.78 ng{\cdot}hr/mL,\;64.48{\pm}27.06 ng/mL,\;0.52{\pm}0.21 hr,\;and\;5.15{\pm}2.67 hr$, respectively, from the plasma bismuth concentration-time curves. In conclusion, the method was suitable for the determination of bismuth in human plasma samples and could be applied to bioequivalence test of bismuth tablet.

• Journal of Pharmaceutical Investigation
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• v.39 no.1
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• pp.7-12
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• 2009

A novel polymeric tablet of Tinidazole was formulated to treat Helicobacter pylori and Giardia lambria more efficiently, It was possible to reduce hepatotoxicity by controlling the release of Tinidazole after peroral administration. A gastric retentive formulation made of naturally occurring carbohydrate polymers and containing Tinidazole was tested in vitro for swelling and dissolution characteristics. Tinidazole tablets containing various concentration of either PEO or HPMC were prepared by the wet granulation method. In vitro release of Tinidazole at pH 1.2 and pH 6.8 buffer solutions was observed at $37^{\circ}C$ by using a KP dissolution method and an UV (313 nm) spectrophotometer. Compared to a commercial Tinidazole tablet, in vitro release of Tinidazole at both pH 1.2 and pH 6.8 buffer solutions significantly decreased as the concentration of PEO or HPMC in the tablet increased up. And the gastric retentive formulation hydrated and swelled back to about 50% of its original size in 30 min. Thus, it was possible to control the release of Tinidazole by changing the content of PEO or HPMC in the tablet, thereby manipulating the release rate and the retention of Tinidazole.

• Journal of Pharmaceutical Investigation
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• v.35 no.1
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• pp.45-50
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• 2005

The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jeil Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.67{\pm}3.12$ year in age and $68.50{\pm}7.23$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were determined using HPLC. Pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.04\;and\;log0.90{\sim}log1.07\;for\;AUC_t\;and\;C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.187-192
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• 2005

The purpose of the present study was designed to evaluate the bioequivalence of two benidipine hydrochloride tablets, Codipine (Youngjin Pharm. Co., Ltd.) and Benipine (Myungmoon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.00{\pm}1.82$ year in age and $70.08{\pm}9.59$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 4 mg of benidipine hydrochloride were orally administered, blood was taken at predetermined time intervals and concentrations of benidipine in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, and $C_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 $(e.g., \;log1.04{\sim}log1.24\;and\;log0.91{\sim}log1.09$ for $AUC_t$, and $C_{max}$ respectively). The major parameters, $AUC_t$ and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Benipine tablet is bioequivalent to Codipine tablet.

• Journal of Conservation Science
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• v.35 no.6
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• pp.670-680
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• 2019

This study attempts to identify whether there were preferred wood species or any required properties depending on the use of wooden objects by comparing wood species analysis results of wooden objects, which are classified specifically by their uses like comb, wooden tablets, containers, etc., excavated from Haman Seongsansansung mountain fortress, which is the archaeological site of the Three Kingdoms era and those excavated from archaeological sites in Gyeongsang province considered to be the similar era of Haman Seongsansansung mountain fortress site. Wooden tablets and combs show the preferred species clearly and containers preferred wood species with the mid-ranged strength and the resistance against moisture migration.

• Journal of Advanced Navigation Technology
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• v.20 no.5
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• pp.468-474
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• 2016

Recently with smartphones and tablets, personal earphones have been using to utilize a wide range of multimedia services. Especially smartphones sold domestically provide earphones as necessaries. As a life style listening to music through smartphones and tablets has been spread widely, there has been in increasing demand of earphones necessary for enjoying music anytime and anywhere. This paper has simplified the complex performance test processes to inspect defective products when producing a large amount of earphonesand has improved the existing performance test processes to reduce the costs and time for the performance test of earphones. In this paper, the improved performance test processes through developing the performance test equipment of earphones can reduce the performance test inspectors, cut down the performance test time, and increase the daily amount of the performance test.

• Journal of Pharmaceutical Investigation
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• v.35 no.5
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• pp.355-360
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,\;log\;0.93-log\;1.08\;for\;AUC_{0-t},\;log\;0.91-log\;1.08\;for\;AUC_{0-{\infty}}\;and\;log\;1.01-log\;1.11\;for\;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.

• Journal of Pharmaceutical Investigation
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• v.35 no.5
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• pp.383-388
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• 2005

A simple and specific method for determination of methyltestosterone (MT) has been established by a gas chromatography/mass selective detector and applied in plasma of healthy male volunteers received a single oral dose of 50 mg MT $(Testo^{TM}\;tablets,\;25\;mg)$ for bioavailability test. This method involves using liquid-liquid extraction of the sample with diethyl ether and derivatization with MSTFA. MT showed good resolution in this condition. The detection limit of quantitation was 5 ng/ml. A good linearity (r>0.996) was obtained at the range of 5-250 ng/ml of MT. Intra-day precision and accuracy were 2.76-12.56% and 0.39-8.01 %, and inter-day precision and accuracy were 2.29-17.69% and 0.42-7.99%, respectively. The established method was applied on bioavailability test of MT in human volunteers. The value of $AUC_{0\;to\;last}$ to last was $264.5{\pm}123.9\;ng{\cdot}hr/ml$ and that of $AUC_{0\;to\;inf}$ was determined to be $275.2{\pm}126.5\;ng{\cdot}hr/ml$. The values of $C_{max}$ and $T_{max}$ were $95.9{\pm}67.1\;ng/ml$ and $1.13{\pm}0.9\;hr$, respectively. The mean elimination half-life $(t_{1/2})$ was $4.4{\pm}0.9\;hr$. This analytical method is suitable and useful for the pharmacokinetics and bioequivalence studies of MT.

• Journal of Pharmaceutical Investigation
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• v.37 no.4
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• pp.249-254
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• 2007

The purpose of the present study was to evaluate the bioequivalence of two baclofen tablets, $Baclan^{TM}$ tablet (Yooyoung Pharm. Co., Ltd., Seoul, Korea, reference drug) and Taepyungyang Baclofen tablet (Pacificpharma Corporation, Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received three tablets containing baclofen 10 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of baclofen were monitored for over a period of 24 hr after the administration by using an LC-MS/MS. $AUC_t,\;C_{max}\;and\;T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals of the $AUC_t$ and the $C_{max}$ for Taepyungyang $Baclofen/Baclan^{TM}$ were $log0.92{\sim}log1.06\;and\;log1.03{\sim}log1.22$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. It was concluded that Taepyungyang Baclofen tablet was bioequivalent to $Baclan^{TM}$ tablet, in terms of both rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.67-73
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• 2011

Ion exchange resins can be one of the good carriers for sustained drug release. However, the sustained release may not be enough only with themselves and hence film coating with rate controlling polymers can be applied to have a further effect on the drug release. Due to the environmental and economic issues of organic solvent for the polymer coating, aqueous polymeric systems were selected to develop dosage forms. Among the many aqueous polymeric dispersions for the film coating, EC (ethylcellulose) based polymers such as Aquacoat$^{(R)}$ ECD and Surelease$^{(R)}$ were evaluated.A fluid-bed coating was applied as a processing method. The drug release rate was quite dependent on the coating level so the release rate could be modified easily by changing different levels of the coating. The drug release rate in the Aquacoat$^{(R)}$ coated resin particles was strongly dependent on curing, which is a thermal treatment to make homogeneous films and circumvent drug release changes during storage. After dissolution test using the compressed tablets in which the coated resin particles are contained, inhomogeneous coating and even pores could be observed showing that the mechanical properties of EC were not resistant to granulation and compaction process. However, when tablets were prepared in different batches, the release profiles were almost identical showing the feasibility of the coated resin particle as incorporated into the tablet formulation.