• Title/Summary/Keyword: capsule

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Bioequivalence Evaluation of Two Brands of Cefixime 100 mg Capsule (Suprax and Alpha-Cefixime) in Korean Healthy Volunteers

  • Choi, Dong-Hyun;Burm, Jin-Pil
    • Biomolecules & Therapeutics
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    • v.15 no.3
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    • pp.182-186
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    • 2007
  • Cefixime is an orally absorbed cephalosporin with a broad spectrum of activity against Gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cefixime capsules, Suprax capsule (Dong-A Pharmaceutical Co., reference drug) and Alpha-Cefixime capsule (Alpha Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal subjects, $23.5{\pm}3.72$ years in age and $68.3{\pm}8.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. There was one week washout period between the doses. After one capsule containing 100 mg of cefixime was orally administered, plasma was taken at predetermined time intervals and the concentrations of cefixime in plasma were determined using HPLC with UV detector. 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. The results showed that the differences in $AUC_{t}$, $C_{max}$ and $T_{max}$ between two products were -3.91%, -2.23% and -3.18%, respectively, when calculated against the reference drug. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of $log0.8{\leq}{\delta}{\leq}log1.25$ (e.g., $log0.8786{\leq}{\delta}{\leq}log1.0523$ and $log0.8889{\leq}{\delta}{\leq}log1.0512$ for $AUC_{t}$ and $C_{max}$, respectively). The 90% confidence intervals using untransformed data was within ${\pm}20%$(e.g., $-10.37%{\leq}{\delta}{\leq}6.73%$ for $T_{max}$). All parameters met the criteria of KFDA for bioequivalence, indicating that Alpha-Cefixime capsule (Alpha Pharmaceutical Co.) is bioequivalent to Suprax capsule (Dong-A Pharmaceutical Co.).

Microencapsulation of Phenyl Acetate with Poly(urea-formaldehyde) (Poly(urea-formaldehyde)에 의한 페닐아세테이트의 미세캡슐화)

  • Jo, Ye-Hyun;Song, Young-Kyu;Yu, Hwan-Chul;Cho, Sung-Youl;Kumar, S. Vijay;Ryu, Byung-Cheol;Chung, Chan-Moon
    • Polymer(Korea)
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    • v.35 no.2
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    • pp.152-156
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    • 2011
  • We have performed microencapsulation of phenyl acetate using poly (urea-formaldehyde) as a shell material, and studied the effect of agitation rate,. core/shell mass ratio, surfactant concentration, and reaction time on capsule characteristics such as size, shell thickness, and surface morphology. The formation of microcapsules was confirmed by FTIR and TGA, and capsule characteristics were studied by optical microscopy and FE-SEM. Capsule size and shell thickness reduced with increasing agitation rate. As the mass of shell material was increased, shell thickness and nanoparticles on capsule surface increased. Capsule size and shell thickness decreased with increasing the concentration of a surfactant. Increasing reaction time caused increased capsule yield and shell thickness.

Determination of Harvesting Time and Effect of Diquat Treatment in Sesame Cropped After Winter Barley (맥류작 참깨의 수확기 결정과 건조제 처리의 효과)

  • Lee, H.J.;Kwon, Y.W.
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.25 no.2
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    • pp.64-67
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    • 1980
  • Field experiments were conducted to determine the optimum harvesting time and to evaluate the effect of Diquat spray in late seeded sesame, cultivar 'Suweon 9'. Sesame seed yield reached a plateau from Sept. 18 harvest when seed number was maximum. Thousand seed wt. increased to Sept. 29 harvest. As harvesting was delayed moisture content of capsule decreased and capsule dehiscence increased. Capsule dehiscence did not start until its moisture content dropped below 70%. Optimum harvesting might begin from the time which moisture content of capsule dropped below 70%, leaf senescence reached upper node, and 50% of capsules lost green. About 5% increase in seed weight after defoliation was estimated to be translocation from capsule wall. Diquat spray with 0.3% and 0.5% (v/v) solution of commercial Reglone (20%in A.I.) decreased rapidly capsule moisture content and promoted seed shattering. Dehiscence in 90% capsules was noted at seven days after Diquat spray. Diquat spray as a harvest aid could accelerate sesame desiccation up to 2 wks from normal field condition.

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A study on the dynamic performance of self-healing capsule based on carbonyl iron particles(CIPs) in magnetic field (자기장 환경에서 카르보닐철입자(CIPs) 기반 자가치유 캡슐의 동적 성능 분석에 관한 연구)

  • Cheng, Hao;Hu, Jie;Lim, Taeuk;Lee, Yeong Jun;Kim, Sangyou;Jung, Wonsuk
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2022.11a
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    • pp.241-242
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    • 2022
  • Recently, related studies on the application of bacterial spores to self-healing concrete have been widely reported. Using the self-healing method of bacterial spores as a kind of pro-environment, the green method is very attractive, but because the living environment of bacterial spores is relatively harsh, it is necessary to have a way to separate the living environment of bacterial spores from the harsh external environment, And release bacterial spores when needed. Therefore, capsules are widely used in self-healing concrete. To enhance the self-healing effect, the capsules need to be evenly distributed in the concrete. Furthermore, we develop a CIP-based smart capsule with controllability. We determined the magnetic force of each capsule by mixing CIP in resin, then mass-fabricating the capsules for self-healing by a microfluidic method, and by measuring the kinetic distance of the capsules containing different amounts of cip under the action of a magnetic field strength. The results show that with the increase of the amount of cip, the active distance of the capsule also increases. When the cip is 8wt%, the active distance reaches 1.75cm. We believe this research can provide momentum for the development of self-healing capsule applications.

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Optimization of Culture Conditions and Encapsulation of Lactobacillus fermentum YL-3 for Probiotics (가금류 생균제 개발을 위한 Lactobacillus fermentum YL-3의 배양조건 최적화 및 캡슐화)

  • Kim, Kyong;Jang, Keum-Il;Kim, Chung-Ho;Kim, Kwang-Yup
    • Korean Journal of Food Science and Technology
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    • v.34 no.2
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    • pp.255-262
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    • 2002
  • This experiment was performed to improve the stability of Lactobacillus fermentum YL-3 as a poultry probiotics. The culture conditions that improve acid tolerance of L. fermentum YL-3 were investigated by changing several factors such as medium composition, temperature, anaerobic incubation and culture time. Also, L. fermentum YL-3 was encapsulated with alginate, calcium chloride and chitosan. The stable culture conditions of L. fermentum YL-3 were obtained in anaerobic incubation using MRS media without tween 80 for 20 hour at $42^{\circ}C$. The capsule after treatment with 1% chitosan was formed close membrane by a bridge bond. Immobilization of L. fermentum YL-3 in capsule was observed by confocal laser scanning microscopy, and cell viability was $2.0{\times}10^9\;CFU/g$ above the average. L. fermentum YL-3 capsule after acid treated at pH 2.0 for 3 hour survived about 40%, but those encapsulated with 1% chitosan survived about 65%. Survival rate of capsule stored at room temperature decreased about $2{\sim}3$ log cycle during 3 weeks, but viability of capsule stored at $4^{\circ}C$ during 3 weeks maintained almost $10^8\;CFU/g$ levels.

Computer Simulation for the Thermal Analysis of the Energy Storage Board (에너지 축열보드 열해석을 위한 컴퓨터 수치해석)

  • 강용혁;엄태인;곽희열
    • Journal of Energy Engineering
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    • v.8 no.2
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    • pp.224-232
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    • 1999
  • Latent heat storage system using micro-encapsuled phase change material is effective method for floor heating of house and building. The temperature profile in capsule block and flow rate of hot water are important parameters for the development of heat storage system. In the present study, a mathematical model based on 3-D, non-steady state, Navier-Stokes equations, scalar conservation equations and turbulence model ($\kappa$-$\varepsilon$), is used to predict the temperature profiles in capsule and the velocity vectors in hot water pipe. The multi-block grids and fine grids embedding are used to join the circle in hot water pipe and square in capsule block. The phase change process of the capsule is quite complex not only because the size of phase change material is very small, but also because phase change material is mixed with the cement to form thermal storage block. In calculation, it's assumed that the phenomena of phase change is limited only the thermal properties of phase change material and the change of boundary is not happened in capsule. The purpose of this study is to calculate the temperature profiles in capsule block and velocity vectors in hot water pipe using the numerical calculation. Two kinds of thermal boundary condition were considered, the first (case 1) is the adiabatic condition for the both outside surfaces of the wall, the second (case 2) is the case in which one surface is natural convection with atmosphere and another surface is adaibatic. Calculation results are shown that the temperature profile in capsule block for case 1 is higher than that for case 2 due to less heat loss in adaibatic surface. Specially, in the domain of near Y=0, the difference of temperature is greater in case 1 than in case 2. The detailed experimental data of capsule block on the temperature profile and the thermal properties such as specific heat and coefficient of heat transfer with the various temperature are required to predict more exact phenomena of heat transfer.

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Rapid and Simple Method for the Determination of Pregabalin in Human Plasma using Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS): Application to a Bioequivalence Study of Daewoong Pregabalin Capsule To Lyrica® Capsule (Pregabalin 150 mg)

  • Jang, Ki-Ho;Seo, Ji-Hyung;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.41 no.4
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    • pp.255-262
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    • 2011
  • Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

Bioequivalence of Kuhnil GabapentinTM Capsule 300 mg to NeurontinTM Capsule 300 mg (Gabapentin 300 mg) (뉴론틴 캡슐 300밀리그람(가바펜틴 300 mg)에 대한 건일가바펜틴 캡슐 300밀리그람의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Eun-Ja;Oh, Se-Won;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.193-199
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    • 2005
  • Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil 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 various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 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 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, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% 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 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

Bioequivalence of MeloxifenTM Capsule to MobicTM Capsule(Meloxicam 7.5 mg) (모빅캡슐(멜록시캄 7.5mg)에 대한 멜록시펜캡슐의 생물학적 동등성)

  • Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Kang, Jong-Min;Ryu, Ju-Hee;Yim, Sung-Vin;Hong, Seung-Jae;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.6
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    • pp.457-463
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    • 2009
  • The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, $Mobic^{TM}$ capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and $Meloxifen^{TM}$ capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a $2{\times}2$ crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). $AUC_t$(the area under the plasma concentration-time curve from time zero to 72 hr), $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were complied 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 $AUC_t$ ratio and the $C_{max}$ ratio for $Meloxifen^{TM}/Mobic^{TM}$ were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that $Meloxifen^{TM}$ capsule was bioequivalent to $Mobic^{TM}$ capsule, based on the rate and extent of absorption.

Bio-capsule Formation for Synchronous Saccharification and Fermentation Process (동시당화발효공정을 위한 바이오캡슐 형성)

  • Shin, Gyeong Yeon;Choi, Hye Jung;Kang, Yang-Rae;Nam, Ki-Du;Song, Ju Yeong;Joo, Woo Hong
    • Microbiology and Biotechnology Letters
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    • v.45 no.2
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    • pp.162-167
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    • 2017
  • For the production of bioethanol by the synchronous saccharification and fermentation (SSF) process, bio-capsule formation was attempted. Many saccharifying fungal strains and fermentative yeast strains were first screened. Aspergillus sp. BCNU 6200, Penicillium sp. BCNU 6201, and P. chrysogenum KACC 44363 were found to be excellent producers of saccharifying enzymes such as ${\alpha}$-amylase and glucoamylase. Saccharomyces cerevisiae IFO-M-07 showed the highest ethanol productivity among the tested strains. Secondly, we determined the optimal conditions for pellet formation, and those for bio-capsule formation. All the tested fungal strains formed pellets, and the optimal conditions for bio-capsule formation were $28^{\circ}C$ and 120 rpm. Lastly, SSF process was performed using a bio-capsule. An ethanol yield of 3.9% was achieved by using the Aspergillus sp. BCNU 6200 bio-capsule (Aspergillus sp. BCNU 6200 + S. cerevisiae IFO-M-07) at $30^{\circ}C$ with shaking at 120 rpm during the 10 days of incubation. The results provide useful information on the application of a bio-capsule in bioethanol production under the SSF process.