• Title/Summary/Keyword: Bio-Pharmaceutical

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Controlled Release of Nifedipine in Multi-layered Granule System (다중층 과립 시스템에서 니페디핀의 방출 제어)

  • Lee, Soo-Young;Youn, Ju-Yong;Kim, Byung-Soo;Kim, Moon-Suk;Lee, Bong;Khang, Gil-Son;Lee, Hai-Bang
    • Journal of Pharmaceutical Investigation
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    • v.37 no.4
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    • pp.229-235
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    • 2007
  • Multi-layered granules were prepared by a fluidized-bed coater and uniformed granules were obtained with a size range between $950{\sim}1000{\mu}m$ in diameter. The granule system was composed of three layers, i.e. seed layer with sugar sphere bead and a water-swellable polymer, middle layer with a drug, solubilizer and polymer, and the top layer of porous membrane with a polymeric binder. The aim of this work is to find out the dependence of a drug dissolution rate on the amount of a water-soluble binder and a solubilizer in the granule system. The results showed that the higher amount of hydrophilic binder in the porous membrane, gave the bigger pore size and porosity and made faster dissolution rate and also the higher amount of solubilizer in drug layer enhanced the dissolution rate of drug.

Bioequivalence of MelaxTM Capsule to MobicTM Capsule (Meloxicam 7.5 mg) (모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성)

  • Lee, Ye-Rie;Yeom, Seung-Bock;Ko, Youn-Jung;Ko, Jung-Kil;Kim, Ho-Hyun;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.413-418
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    • 2004
  • A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of NimegenTM Soft Capsule to RoAccutane® Soft Capsule (Isotretinoin 10 mg) (로아큐탄 연질캡슐(이소트레티노인 10 mg)에 대한 니메겐 연질캡슐의 생물학적동등성)

  • Yang, Seung-Kwon;La, Sook-Ie;Chang, Kyu-Young;Lee, Yun-Young;Yoon, Mi-Kyeong;Lew, Soo-Hyun;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.4
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    • pp.255-261
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    • 2007
  • A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 hr) was calculated by the linear trapezoidal rule method. $C_{MAX}$ (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 $AUC_t\;and\;C_{MAX}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{MAX}$ ratio for $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.209-214
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    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (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 $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

Concentration/Purification Technologies: Multi-Functionalities of Nanostructures in Biosensing Fields

  • Son, Sang Jun;Min, Junhong
    • Proceedings of the Korean Vacuum Society Conference
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    • 2013.02a
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    • pp.87-87
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    • 2013
  • Sample concentration and purification processes are essential in the bio-analytical and pharmaceutical fields because most bio samples or media are extremely sophisticated. To concentrate and purify specific substances, passive membrane type filters have been utilized, which is driven by size or charge differences between target and others. The traditional and representative method to identify nucleic acid sequences in the complex biosample is gel electrophoresis, which has been worked by size and net charge of molecules. The adsorption phenomena have been also utilized to concentrate and purify biomolecules. This adsorption of biomolecule can be controlled under specific salts and surfaces as well as surface area. To utilize the differences of physical properties of molecules or bio-targets such as virus, bacteria, and cells, the nanotechnologies can be introduced in target concentration, purification, and isolation processes. In here, I'd like to briefly survey typical examples of nanobiotechnologies which are introduced in sample treatment. Also I specifically demonstrate two different simple techniques to concentrate and detect bacteria from the samples using multifunctional silica nanotube (SNT).

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Cystocin, a Novel Antibiotic, Produced by Streptomyces sp. GCA0001: Biological Activities

  • Lee, Hei-Chan;Liou, Kwangkyoung;Kim, Dae-Hee;Kang, Sun-Yub;Woo, Jin-Suk;Sohng, Jae-Kyung
    • Archives of Pharmacal Research
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    • v.26 no.6
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    • pp.446-448
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    • 2003
  • Cystocin belongs to the class of nucleoside antibiotics from Streptomyces sp. GCA0001. Cystocin showed good activity against Gram-positive bacteria, but showed less activity against the Gram-negative bacteria. Cystocin exhibited about two to four folds higher activity than puromycin. Especially, cystocin shows relatively strong activity against Streptococcus strains. Cystocin shows quite potent antitumor activity against all of the cells tested showing $IC_{50}$ values of 0.10 to 0.14 $\mu$ g/mL. This in vitro result indicates that the cytotoxocity of cystocin is two ten folds more active than puromycin s.

Anxiolytic-like effects of Portulaca oleraceae L. using the elevated plus-maze in mice

  • Lee, Chang-Hwan;Yoon, Byung-Hoon;Ryu, Jong-Hoon;Jung, Ji-Wook
    • Advances in Traditional Medicine
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    • v.9 no.2
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    • pp.135-141
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    • 2009
  • The purpose of this study was to characterize the putative anxiolytic-like effects of the 70% ethanol extract of Portulaca oleracea (EPO) using an elevated plus maze (EPM) in mice. The EPO was orally administered at 50, 100, 200 or 400 mg/kg to ICR mice, 1 h before the behavioral evaluation in the EPM, respectively. Control mice were treated with an equal volume of 10% tween 80, and positive control mice with diazepam (1 mg/kg). Single treatments of the EPO significantly increased the percentage of time spent and arm entries into the open arms of the EPM versus controls (P < 0.05). Moreover, there were no changes in the locomotor activity and myorelaxant effects in any group compared with the saline controls. In addition, the anxiolytic-like effects of the EPO were blocked by flumazenil (10 mg/kg, i.p), a $GABA_A$ antagonist not by WAY 100635 (0.3 mg/kg, i.p), a 5-$HT_{1A}$ receptor antagonist. These results indicate that P. oleracea is an effective anxiolytic agent, and suggest that the anxiolytic-like effects of P. oleracea is mediated via the GABAergic nervous system.

A Study on the Vinegar Fermentation Processes of Fresh Korean Ginseng Extract Using Mix Microbial Yinkin (유익하게 인체에 작용하는 균(유인균)을 이용한 인삼발효식초 제조과정에 대한 특성연구)

  • Hwang, Se Ran;Destiani, Supeno;Kwon, Soon Hong;Chung, Sung Won;Kwon, Soon Goo;Park, Jong Min;Kim, Jong Soon;Choi, Won Sik
    • Journal of the Korean Society of Industry Convergence
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    • v.20 no.4
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    • pp.345-350
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    • 2017
  • Saponin is the most pharmaceutical active ingredients of the ginseng plant, it was called "Ginsenoside" which means the Glycoside of ginseng that composed glycosides and aglycones. The human body will absorb the saponin easily if these substrate was decomposed by active microorganism. Fermentation is the most convenient technique to decompose this active ingredients. The purpose of this research was to study the sugar content, pH and acidity development during the ginseng fermentation process. Fresh Korean ginseng and red ginseng extract was used as the main ingredient. The concentrated of pure ginseng extract was added to increase the saponin extract. Furthermore, the mix microbial powder was added as starter to increase the fermentation efficiency. The ginseng was fermented in fermentation chamber at temperature $37^{\circ}C$ during 70 days. In the end of experiment the sugar content was decreased from 24% to 7.65%, The pH was decreased from 6.5 to 3.4, and the acidity level was incresed from 0% to 1.2%.