• YAKHAK HOEJI
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• v.52 no.4
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• pp.299-305
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• 2008

Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The 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 $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.

• Journal of Pharmaceutical Investigation
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• v.38 no.6
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• pp.413-419
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• 2008

Carvedilol, is a nonselective $\beta$-blocking agent and it also has vasodilating properties that are attributed mainly to its blocking activity at ${\alpha}_1$-receptors. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{(R)}$ tablet 12.5 mg (Chong Kun Dang Pharmaceutical Co., Ltd.) and Cadilan tablet 12.5 mg (KyungDong Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of carvedilol from the two carvedilol formulations in vitro was tested using KP VIII Apparatus II method with pH 4.5 dissolution medium. Thirty two healthy male subjects, $25.00{\pm}3.09$ years in age and $70.71{\pm}11.35\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 12.5 mg as carvedilol was orally administered, blood samples were taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Dilatrend^{(R)}$ tablet 12.5 mg, were 4.66%, 8.33% and -7.45% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $\log\;0.9823{\sim}\log\;1.1042$ and $\log\;1.0132{\sim}\log\;1.1875$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Cadilan tablet 12.5 mg was bioequivalent to $Dilatrend^{(R)}$ tablet 12.5 mg.

• YAKHAK HOEJI
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• v.52 no.3
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• pp.195-200
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• 2008

Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

• YAKHAK HOEJI
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• v.52 no.3
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• pp.188-194
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• 2008

Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

• Journal of the Korean Society for Heat Treatment
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• v.24 no.4
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• pp.187-192
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• 2011

Effect of austenitizing temperatures on the impact value of the AISI 4140 steel after repetition of spheroidization and cold deep drawing treatment has been studied. Sufficient dissolution of carbide was shown after austenitizing at the high temperature of $950^{\circ}C$. Accordingly, the impact value was remarkably increased by tempering of this high temperature austenitized steel at the tempering temperature ranges between $570^{\circ}C$ and $630^{\circ}C$. On the other hand, remarkable decrease in the impact values and elongations were shown by tempering the low temperature-austenitized ($870^{\circ}C$) steel due to the coarsening of undissolved-carbide existed at the austenitizing temperature.

• Journal of the Korean Ceramic Society
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• v.46 no.2
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• pp.123-130
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• 2009

To understand the formation of core-shell structure in $BaTiO_3$ (BT) grains in multilayer ceramic capacitors, specimens were prepared with BT powders mixed with Y and Mg, and their microstructures were investigated with scanning electron microscopy, x-ray diffractometry, and transmission electron microscopy. Microstructural investigation showed that Y dissolved easily in BT lattice to a certain depth inside of the grain, whereas Mg tended to stay at grain boundaries rather than become incorporated into BT. It was considered that in case of Y and Mg addition in a proper ratio, Y could play a dominant role in the formation of shell leading to a slight dissolution of Mg in the shell. Next, the effects of ball-milling conditions on the core-shell formation were studied. As the ball-milling time increased, the milled powders did not show a significant change in size distribution but rather an increase of residual strain, which was attributed to the milling damage. The increase in milling damage facilitated the shell formation, leading to the increased shell portion in the core-shell grain.

• ETRI Journal
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• v.35 no.4
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• pp.571-577
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• 2013

The fabrication of a thin-film transistor backplane and a liquid-crystal display using printing processes can eliminate the need for photolithography and offers the potential to reduce the manufacturing costs. In this study, we prepare contact via structures through a poly(methyl methacrylate) polymer insulator layer using inkjet printing. When droplets of silver ink composed of a polymer solvent are placed onto the polymer insulator and annealed at high temperatures, the silver ink penetrates the interior of the polymer and generates conducting paths between the top and bottom metal lines through the partial dissolution and swelling of the polymer. The electrical property of various contact via-hole interconnections is investigated using a semiconductor characterization system.

• Corrosion Science and Technology
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• v.22 no.5
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• pp.322-329
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• 2023

There are a variety of heat exchangers used in automobiles, such as shell and tube heat exchangers, double tube heat exchangers, and plate heat exchangers. Most of them are water-cooled to prevent engine overheating. There have been reports of corrosion damage to these heat exchangers due to continuous wetting caused by external temperature differences, road pollutants, and snow removal. In addition, galvanic corrosion, which occurs when two dissimilar materials come into contact, has been identified as a major cause. In this study, corrosion characteristics and galvanic corrosion behavior of Al alloy (AA3003, AA4045 and AA7072) used in automobile heat exchangers were analyzed. Effective clad materials for heat exchanger tubes and fins were also evaluated. It was found that AA7072 should be applied as the cladding material for fin AA3003 and that AA4045 was suitable as a cladding material for tube AA3003 because this clad materials application was the most effective clad design to delay the occurrence of pinhole in the tube. Main factors influencing galvanic corrosion dissolution were found to be galvanic corrosion potential difference and galvanic corrosion current density.

• Polymer(Korea)
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• v.32 no.4
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• pp.328-333
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• 2008

The osmotic delivery systems are based on osmosis. The transverse diffusion of water through a porous membrane from a medium with a low osmotic pressure to a medium with a high osmotic pressure. Nifedipine tablet dosage forms of Procardia $XL^{(R)}$(Pfizer) and $Adalat^{(R)}$(Bayer) are commercialized systems of this type that push-pull osmotic tablet operates successfully in delivering water-insoluble drugs. We prepared osmotic pellet system by fluidized bed coating method, and model-drug used nifedipine. The osmotic pellet system was composed of the core material. the swelling and osmotic pressure layer, the drug coating layer, and the porous membrane. This work is performed to investigate the effect of different factors, such as composition and thickness of membrane. The osmotic pellet has been successfully prepared by fluidized bed coating technology. The drug release behavior depended on the increase of CA ratio and thickness in porous membrane. The morphology of the osmotic pellet before and after the dissolution test were observed by SEM. In conclusion, we found that the drug release of osmotic pellet depended on the composition and coating thickness of porous membrane.

• Polymer(Korea)
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• v.32 no.4
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• pp.322-327
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• 2008

In this study, a multi-layered pellet was composed of a seed layer including a water-swellable agent and a drug layer containing doxazosin as a model drug, a porous membrane and a castor oil layer to control drug release. The pellet is prepared by a fluidized bed coating method. To confirm drug release from polymer blending in multi-layered pellet system, it is prepared by containing different ratio such as hydroxypropylmethylcellulose (HPMC) : ethyl cellulose (EC) in drug layer and cellulose acetate(CA) : Eudragit RS in membrane. Also, to confirm the effect of oil in drug release, castor oil is coated. As a result, we observed regularly spherical pellet with diameter of $1500{\mu}m$. Release pattern of drug is confirmed by dissolution tester in aqueous media. The more the ratio of EC in drug layer, CA in membrane, and castor oil layer in pellet, the less the drug release is observed. Formation and the amount of pores in membrane is observed by SEM.