• Title/Summary/Keyword: ICH

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Stability of the Oil-in-water Type Triacylglycerol Emulsions

  • Hesson Chung;Kim, Tase-Woo;Kwon, Ich-Chan;Jeong, Seo-Young
    • Biotechnology and Bioprocess Engineering:BBE
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    • v.6 no.4
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    • pp.284-288
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    • 2001
  • Lipid emulsions with saturated triacylglycerols (TAGs) with 4 to 10 carbons in each acyl chain were prepared to study how the oil component alters the stability of the lipid emul-sions when phosphatidylcholines were used as emulsifiers. The average droplet size of the emul-sions became smaller as the chain length of the TAG increased. For a given oil emulsion with smaller droplets was formed with an emulsifier having higher HLB value. The influence of HLB values on the droplet size was biggest for the tributyrin (C4) emulsion. For the tricaprylin(C8) emulsions, droplet size was identical at given emulsifier concentrations regardless of HLB values. The HLB value and the concentration of the emulsifiers also affect the droplet size of the emul-sions. The emulsions with smaller average droplet size were more stable than with bigger size for 20 days. The oil and water (o/w) interfacial tension in inversely proportional to the initial droplet size of the emulsion.

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Development and Stability Evaluation of Enteric Coated Diclofenac Sodium Tablets Using AquaPolish E.

  • Zaid, A.N.;Fadda, A.M.;Nator, S.;Qaddumi, A.
    • Journal of Pharmaceutical Investigation
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    • v.41 no.4
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    • pp.211-215
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    • 2011
  • The aim of this study was to develop a stable enteric coated diclofenac sodium (DFS) tablets using Aqua-Polish E without using a subcoat. DFS uncoated tablets were manufactured through the non direct compression process. AquaPolish E white aqueous coating dispersion was used as enteric coating material. This film forming polymer is a mixture of selected polymethacrylic/ethylacrylate copolymers. The stability of the obtained enteric coated tablets was evaluated according to ICH guidelines. No signs of disintegration or cracking was observed when they placed in 0.1N HCl solution (pH1.2), but they were completely disintegrated within 10 minutes when they placed in buffered solution at pH6.8. Dissolution test was also conducted by placing tablets in 0.1 N HCl for 2 hours and then 1 hour in phosphate buffer at pH 6.8. Less than 0.9 % of drug was released in the acidic phase and up to 97% in the basic medium. These findings suggest that aqueous enteric coating with AquaPolish E system is an easy and economical approach for preparing stable DFS enteric coat without the use of a subcoating layer.

Modeling and Analysis of Modified Active Frequency Drift Method (개선된 AFD기법의 모델링 및 분석)

  • An, Jin-Ung;Yu, Gwon-Jong;Choy, Ich;Choi, Ju-Yeop;Lee, Ki-Ok
    • The Transactions of the Korean Institute of Power Electronics
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    • v.16 no.2
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    • pp.145-151
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    • 2011
  • In this paper, among the active islanding detection techniques, the modified active frequency drift method was analyzed, which is relatively easy to apply to the single-phase grid-connected PV PCS. The existing designs for turbulences in these applications were empirically conducted, and do not have sufficient reliability and performance. Therefore, three application forms of the modified active frequency drift technique were modeled, based on which the proper magnitude of turbulence, which is the frequency acceleration component, was calculated. Using the results, the magnitude of and injection method for turbulence for ensuring the islanding detection performance and improving the output power quality were proposed, and they were verified via simulations and experiment to prove that the reliable islanding detection technique can be developed merely by measuring the basic output power quality, without the need for expensive islanding simulation equipment.

Quantitative Analysis of Acanthopanacis Cortex and Achyranthis Radix for Standardization of GCSB-5 Preparation (생약복합제 GCSB-5의 품질 표준화를 위한 오가피 및 우슬의 함량 분석)

  • Lee, Eun-Hee;Cha, Bae-Cheon
    • Korean Journal of Pharmacognosy
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    • v.39 no.4
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    • pp.316-323
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    • 2008
  • In this study, we have investigated the HPLC analysis methods and quantitative analysis of standard compounds for quality standardization of a medicinal crude drug GCSB-5, a herbal formulation consisting of 6 medicinal plants (Acanthopanacis Cortex, Achyranthis Radix, Ledebouriellae Radix, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex) which are used in traditional medicine to treat various bone disorders. HPLC analysis methods of acanthoside D(Acanthopanacis Cortex), 20-hydroxyecdysone(Achyranthis Radix) which were known standard compounds among 6 medicinal plants were developed on crude material and product. And validation of HPLC analysis methods were conformed for verification of HPLC methods by check to specificity, linearity, intra-day precision, inter-day precision and accuracy following ICH guideline. Content of acanthoside D and 20-hydroxyecdysone on raw material of GCSB-5 were decided at 0.577-0.578 mg/g and 0.311-0.312 mg/g. And we confirmed that content of acanthoside D and 20-hydroxyecdysone on GCSB-5 preparation were 0.302-0.303 mg/capsule and 0.113-0.115 mg/capsule.

Stereochemical Issues in Chiral Drug Development (광학활성의약품 개발과정에서의 입체화학적 문제)

  • Choi, Sun-Ok;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.35 no.1
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    • pp.57-63
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    • 2005
  • Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.

Alternative chromatographic method for the assay test of terbutaline and salbutamol using ionic liquid assisted aqueous mobile phase

  • Mai, Xuan-Lan;Choi, Yusung;Truong, Quoc-Ky;Nguyen, Thi-Ngoc-Van;Han, Sang Beom;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.33 no.4
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    • pp.169-176
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    • 2020
  • Separation of basic compounds using reverse phase chromatography on a silica-based stationary phase represents a major challenge, because of the interaction between the cationic sites of the basic compounds with the anionic silanols of the stationary phase. This study presents a simple, reliable, and organic solvent - free liquid chromatographic method for the determination of terbutaline and salbutamol, in which a room temperature ionic liquid (RTIL) is used as mobile phase additive. We investigated various mobile phase parameters affecting the retention of the two compounds, such as types and concentration of RTILs and, pH of the mobile phase were investigated. The developed method was validated according to International Conference on Harmonization (ICH) guidelines and successfully applied effectively to determine salbutamol sulfate in pharmaceutical preparations.

A Parametric Study on Seismic Performance of Internally Confined Hollow RC Columns (내부 구속 중공 RC 기둥의 내진성능에 관한 매개 변수 연구)

  • Won, Deok-Hee;Han, Taek-Hee;Kim, Jung-Hun;Choi, Jun-Ho;Kang, Young-Jong
    • Journal of the Korean Society for Advanced Composite Structures
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    • v.3 no.2
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    • pp.28-35
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    • 2012
  • Recently, there is to increase interest in seismic performance of piers. Hollow section is applied to increasing the seismic performance of piers. However, hollow RC pier becomes the biaixial confining state because hollow part is not confined. The pier is developed brittle failure from inner face in hollow part. A tube is inserted in hollow part to become the weakness. This is ICH RC(Internally Confined Hollow RC) pier. This pier is enhanced stiffness, strength, and ductility by core concrete has triaxial confining stress. In this paper is researched about parameters effect the seismic performance. Parameters are hollow ratio, transverse reinforcement, longitudinal reinforcement, and concrete strength.

Improvement on the Formability of Magnesium Alloy Sheet by Heating and Cooling Method (가열냉각방법에 의한 마그네슘합금의 판재성형성 개선)

  • Kang, Dae-Min;Manabe, Ken-ich
    • Transactions of Materials Processing
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    • v.14 no.7 s.79
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    • pp.607-612
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    • 2005
  • In this paper, warm deep drawing process with local heating and cooling technique was attempted to improve the formability of AZ31 magnesium alloy which is impossibly to form by conventional methods at room temperature by finite element method and experiment. For FE analysis, in first model with considering heat transfer, both die and blankholder were heated to 573K while the punch was kept at room temperature by cooling water. Also distribution of thickness and von Mises stress at room temperature and 498k for warm deep drawing were compared by FEM. Uniaxial tension tests at elevated temperature were done in order to obtain the temperature dependence of material constant under temperature of $293K\~573K$ and cross head velocity of $5\~500mm/min$. The phenomenological model for warm deep drawing process in this work was based on the hardening law and power law strain rate dependency. Deep drawing experiment were conducted at temperatures of room temperature, 373K, 423K, 473K, 498K, 523K, and 573K for the blank and deep drawing tools(holder and die) and at a punch speed of 10mm/min.

The Recommended Approaches and Recent Trends in Reproductive and Developmental Toxicology (생식 · 발생독성시험의 방법적 고찰과 최신 연구 동향)

  • Kwack, Seung-Jun;Cho, Dae-Hyun
    • Toxicological Research
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    • v.21 no.4
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    • pp.271-278
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    • 2005
  • Reproductive and developmental toxicology is concerned with various physical or chemical agents interfering with fertility in both gender or normal growth of offsprings. Reproductive and developmental toxicology is rather a complex science, with many fields, i.e., various endpoints are involved and many different mechanisms of action. For that reason, diverse aspects must be considered when attempting to assess possible adverse health effects in the area of reproductive and developmental toxicology. The thalidomide tragedy made it clear to regulatory authorities around the world that systematic, comprehensive evaluation of the reproductive cycle was needed to adequately evaluate the potential of medicinal drugs to impair the process of reproduction or the development of embryos, fetuses, and children. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) developed a guideline to assess the reproductive and developmental toxicity. Also these guidelines have since been applied to the detection and regulation of environmental toxicants, food additives, and so on. Although it was hoped that testing procedures of guideline would be updated constantly to reflect the current state of the science in reproductive and developmental toxicology, it was not until this decade that regulatory guidelines and testing methods have been altered in a significant way. In this paper, we would like to present the recommended approaches and recent trends for improvement of testing guidelines or experimental methods in reproductive and developmental toxicology.

Simultaneous Determination of Four Compounds from Artemisia capillaris using High Performance Liquid Chromatography-Ultraviolet Detector (HPLC-UVD) and Their Quantitative Study in Artemisia Genus

  • Ko, Kiwon;Hong, In Kee;Cho, Hyun-Jong;Kim, Young Ho;Yang, Heejung
    • Natural Product Sciences
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    • v.24 no.2
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    • pp.109-114
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    • 2018
  • Artemisia capillaris Thunb. (Compositae) is a native herb of East Asian countries and has used for the treatment of jaundice, high liver fever, and digestive diseases for a long time, as well as being developed as the source of herbal preparations until now. The major components from A. capillaris were chlorogenic acid (1) and its derivatives substituted with caffeoyl moieties, such as 3,5-dicaffeoylquinic acid (2) and 4,5-dicaffeoylquinic acid (3), and coumarins, such as scoparone. In the study, four compounds, chlorogenic acid, 3,5-dicaffeoylquinic acid, 4,5-dicaffeoylquinic acid and scoparone (4) in the 70% ethanolic extract of A. capillaris were simultaneously determined by using HPLC-UVD system. This method was validated with the terms of linearity, precious and accuracy according to ICH guidelines. The developed method was successfully applied for the quantitative analysis of Artemisia genus, A. capillaris, A. iwayomogi, A. princeps, and A. argyi, distributed in Korea.