• Title/Summary/Keyword: Order release

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Preparation and in vitro Evaluation of a Buoyant Hydrogel Matrix with Hydroxypropylcellulose and Carbopol (히드록시프로필셀룰로오스와 카르보폴을 이용한 부유성 히드로겔 매트릭스의 제조 및 in Vitro 평가)

  • Kim, Sang-Hun;Lee, Min-Suk;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.26 no.2
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    • pp.137-144
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    • 1996
  • The study was carried out for the preparation and evaluation of a buoyant hydrogel matrix (BHM), which is buoyant in a neutral or in pH 2.0 buffer solution, by the aspects of buoyancy, swelling, and drug release. Physical mixtures of HPC and CP in various molar ratio were employed as a mucoadhesive polymer which swells and controls the rate of drug release. Anhydrous citric acid and sodium bicarbonate in the molar ratio of 1:3 were employed as effervescing agents which provide a buoyancy for the mucoadhesive polymeric matrix. The buoyancy in vitro was expressed as both floating time$(T_{fl})$ and surfing time$(T_{sf})$, which are the time required for floating from the bottom to the surface of the medium and the time to keep the floated state at the surface of medium during release studies, respectively. A close relationship was observed between the buoyancy and the amount of effervescing agent added. $T_{fl}$ of the buoyant hydrogel matrices were decreased to about 10 seconds linearly with increasing the amount of effervescing agent in the range of 5 to 15%. $T_{sf}$ of the buoyant hydrogel matrices were varied from 1 to 3 hr depending on the amount of effervescing agent. The swelling was observed by changes in diameter of the buoyant hydrogel matrices in distilled water or acidic buffer solution, resulted in dependences on pH and the amount of effervescing agents. The release of hydrochlorothiazide from the buoyant hydrogel matrices were followed by apparent zero-order kinetics, while the buoyant hydrogel matrices were floated at the surface and maintaining their swollen shapes.

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Scrutiny Made to SUPAC-IR Dealing with Postapproval Changes in Immediate Release Sold Oral Dosage Forms (경구용 속방성 성형제품의 허가 후 변경사항을 다루는 SUPAC-IR에 대한 검토)

  • Sah, Hong-Kee;Park, Sang-Ae;Yun, Mi-Ok;Kang, Shin-Jung
    • Journal of Pharmaceutical Investigation
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    • v.34 no.1
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    • pp.57-71
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    • 2004
  • The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

In Vitro Dissolution of Felodipine from Extended-Release Pellets (펠로디핀 방출연장형 펠렛의 용출 특성 평가)

  • Park, Jeong-Sook;Nam, Kyung-Wan;Shin, Kwang-Hyun;Park, Jong-Bum;Kim, Min-Soo;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.3
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    • pp.193-196
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    • 2007
  • This study aimed to evaluate and develop $Eudragit^{(R)}$-coated pellets based on the dissolution using the paddle method. As coating materials, two types of $Eudragit^{(R)}$ were applied to obtain either sustained release form or fast released form. The dissolution test was carried out in phosphate buffer solution (pH 6.5) at $37^{\circ}C$, 100 rpm. In order to develop a sustained release preparation containing felodipine, a comparative dissolution study was done using commercial product as a control. The dissolution at 30 min of felodipine from $Eudragit^{(R)}$ RS or RL-coated pellets were 0.96% and 99.65, respectively. The weight ratio of $Eudragit^{(R)}$ RL pellets to RS pellets altered the dissolution rate, but did not optimize the dissolution rate. However, the sustained dissolution of felodipine from pellets was optimized by varying the coating ratios of $Eudragit^{(R)}$ RS. It is suggested that the coating ratio of pellets is the main factor which controls dissolution rate. Taken together, $Eudragit^{(R)}$ RS 30D-coated pellets showed the most comparable dissolution rate pattern to commercial product, $Splendil^{(R)}$. This sustained release pellets for oral delivery system of felodipine was simply manufactured, and drug release behavior was highly reproducible.

Effects of pH, Temperature, and Dissolved Oxygen on Phosphorus Release from Marine Sediment to Seawater (해양퇴적물 인 용출에 미치는 pH, 온도, 용존 산소 농도의 영향)

  • Cheon, Hyo-Chang;Nam, Se-Yong;Kim, Sang-Hyoun
    • Journal of Navigation and Port Research
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    • v.36 no.6
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    • pp.513-519
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    • 2012
  • Understanding the behavior of pollutants in the marine environment is essential for coping with the marine pollution problems such as eutrophication. In this study, the effects of environmental parameters on phosphorus release from marine sediment to sea water were investigated. The environmental parameters such as pH in the range of 7 to 9, temperature from 10 to 20C and dissolved oxygen levels (DO) renging 0.7 to 7.0mg/L were examined. Phosphorus release data were taken from batch tests excluding biotic effects, and analyzed using a first-order kinetic model. The effects of environmental parameters were quantified using a statistical methodology. High pH, high temperature, and low DO increased phosphorus release from the sediment to sea water. pH from 7 to 9, temperature from 10 to $20^{\circ}C$, or DO from 7.0 to 0.7 mg/L magnified the equilibrium phosphorus concentration up to 2~3 times.

The Study of a Correlation between Heat Release and Smoke Production by Using Oxygen Consumption Calorimeter Up to 10 MW Facility (10MW급 까지의 산소소모율법 칼로리미터를 활용한 열방출률과 연기발생률의 상관성에 관한 연구)

  • Ryu, Sang-Hoon;Yoo, Yong-Ho;Rie, Dong-Ho
    • Fire Science and Engineering
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    • v.24 no.3
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    • pp.58-65
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    • 2010
  • The fire accidents having recently occurred are getting more and more larger and causing lots of damage in terms of property loss and casualties increase, so there is in need of technical fire safety development like comprehensive prevention solution in order to effectively prevent. Especially, the needing of new paradigm for advanced fire safe technology is gathering strength in high-rise modern building construction. Therefore, we want to find out on this paper what is a correlation between heat release rate measurement and smoke release volume by three parts of oxygen consumption calorimeter in bench scale calorimeter (cone calorimeter/ISO 5660/Avg.500Kw), Medium scale calorimeter (Room corner tester, Single burning Item/ISO 9750, EN 13823/Avg.3MW), and large scale calorimeter (Industry calorimeter/Avg. 10MW). Thus, Smoke detective of new paradigm devised by making use of a correlation between heat release and smoke production is to help reduce loss property and casualties. Ultimately, based on this theory, a new concept of fire alarm and evacuation system will be developed and expected to apply to a skyscraper.

Development of a Korean roadmap for technical issue resolution for fission product behavior during severe accidents

  • Kim, Han-Chul;Ha, Kwang Soon;Kim, Sung Joong;Seo, Miro;Kang, Sang-Ho;Lee, Doo Yong;Song, Yong-Mann;Lee, Jongseong;Im, Hee-Jung;Cho, Chang-Sok;Yeon, Jei-Won;Kim, Sung Il;Cho, Song-Won;Song, Jinho;Ryu, Yong-Ho
    • Nuclear Engineering and Technology
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    • v.49 no.8
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    • pp.1575-1588
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    • 2017
  • In order to develop a domestic research roadmap for severe accidents, a special committee was established by the Korean Nuclear Society. One of the subcommittees discussed the characteristics and the relevant technical issues in the stages of fission product release and physical forms of radionuclide release and transport. The group members developed a tree to identify fission product release phenomena by tracing failures of individual defense-in-depth barriers and added possible countermeasures against failure. For each elemental issue, they searched for technical problems by examining the phenomena, accident management actions, and regulatory aspects relevant to the mitigation features for containment, including mitigation strategies against containment bypass accidents. Regulatory concerns, including the source term and the acceptance criteria for radionuclide release, were also considered. They identified further research needs regarding important technical issues based on the degree of the current knowledge level in Korea and in foreign countries, looking at the significance and urgency of issues and the expected research period required to reach an advanced level of knowledge. As a result, the group identified the 12 most important and urgent issues, most of which were expected to require mid-term and long-term research periods.

Combustional Characteristics of Living Leaves for Five Shrubs in Youngdong Areas (영동지역 관목류 5가지 수종 생엽의 연소특성)

  • Lee, Hae-Pyeong;Lee, Si-Young;Park, Young-Ju
    • Journal of the Korean Society of Hazard Mitigation
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    • v.9 no.3
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    • pp.81-87
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    • 2009
  • In this study, we have investigated the combustibility of five shrubs growing in Youngdong area such as Lindera obtusiloba, Lespedeza maximowiczii, Zanthoxylum piperitum, Zanthoxylum schinifolium, and Corylus heterophylla var. thunbergii using the ignition temperature tester, the cone calorimeter and the smoke density chamber in order to estimate the danger of a forest fire. The results showed that Lespedeza maximowiczii has the lowest ignition temperature, the fastest ignition time and the highest average release concentrations of CO and $CO_2$. Zanthoxylum piperitum and Zanthoxylum schinifolium showed the highest level in heat release and smoke release, respectively. Therefore, we have concluded that Lespedeza maximowiczii has the highest ignitibility, Zanthoxylum piperitum the most intensive fire spread and fire intensity, and Zanthoxylum schinifolium and Lespedeza maximowiczii most difficult to escape from a forest fire.

Measurements and CFD Analysis for Release Rate of CO2 and Characteristics of Natural Ventilation in Lecture Room (강의실 CO2 발생률과 자연환기 특성의 측정 및 CFD 분석)

  • Lee, Donghae;Choi, Youngbo
    • Journal of the Korean Society of Safety
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    • v.36 no.1
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    • pp.86-94
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    • 2021
  • Lecture rooms are crowded with many attendees. Moreover, they rely significantly on the natural ventilation through windows for removing and controlling indoor contaminants such as CO2. With the aim of broadening the understanding of the characteristics of natural ventilation phenomena in lecture rooms, the average individual CO2 release rates of attendees were measured during the course of a lecture and compared with previously reported CO2 release rates. In addition, the effects of natural ventilation through windows on the time-variant CO2 concentrations in the center of the lecture room were measured and analyzed. Moreover, details about the overall and regional CO2 concentrations, as well as the air flows in the lecture room, were simulated and analyzed with computational fluid dynamics software, Fluent 2020 R2. It was found that the average individual CO2 release rates were slightly slower than previously reported rates. The local CO2 concentrations in the lecture room for regions with a high density of attendees increased over a short period of time, although the natural ventilation was already started by opening the windows. The overall CO2 concentration in the lecture room rapidly decreased in the early stage of ventilation, but declined very slowly after a longer period of ventilation time. Therefore, in order to enhance the efficiency of a lecture room's natural ventilation, it is recommended to homogeneously distribute the attendees in the lecture room, and to frequently open the windows for short periods of time.

A study of the HRR and fire propagation phenomena for the fire safety design of deep road tunnel (대심도터널 화재 안전 설계를 위한 승용차의 열방출률 및 화재전파 특성에 관한 연구)

  • Yoo, Yong-Ho;Kweon, Oh-Sang
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.12 no.4
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    • pp.321-328
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    • 2010
  • The study performed an actual fire experiment in order to propose the heat release rate of automobile that is the most basic architectural element for the fire safety design in a tunnel, whose importance has been recognized as the underground traffic tunnels are planned in Korean metropolitan cities. The heat release rate of a van is measured by the large scale calorimeter, in which the law of oxygen consumption is applied, and the fire expansion characteristics in a tunnel by placing two passenger cars nearby one another in the tunnel. As the results, the heat release rate of the van was revealed to be 5.9 MW, and carbon monoxide was emitted 482 ppm at a maximum. In case of two passenger car experiment for the fire expansion characteristics, the adjacent car was ignited about 3 minutes 30 seconds after the fire occurrence, and the complete fire was developed after 15 minutes. The maximum heat release was 9 MW. The results from the actual fire experiment can be an important input data for future quantitative analysis as well as an element applicable to a tunnel disaster preventive equipment design.

Preparation of Double Layered Nanosphere Using Dextran and Poly(L-lactide- co-glycolide) (덱스트란과 락타이드글리콜라이드 공중합체를 이용한 이중층 나노미립구 제조)

  • Hong Keum Duck;Ahn Yong San;Go Jong Tae;Kim Moon Suk;Yuk Soon Hong;Shin Hyung Sik;Rhee John M;Khang Gilson;Lee Hai Bang
    • Polymer(Korea)
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    • v.29 no.3
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    • pp.260-265
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    • 2005
  • The initial burst of drug release is an important role in the controlled delivery of drug having hish toxicity and narrow therapeutic ranges. Nanosphere composed of monolayer could not achieve precisely controlled drug release because of the initial burst of drug on surface. In this study, double layered nanosphere was prepared for sustained drug delivery without initial burst. Double layered nanosphere composed of dextran and PLGA was fabricated by using conventional W/O/W double emulsion method. To control surface tension on the outer layer of nanospheres, PVA was used as a surfactant. Release behavior of dextran as model drug was observed as the $3{\times}1$mm wafers formed by compression mould in the deionized water for 7 days. Double layered nanosphere has sustained release behavior, in contast to single layered nanospheres. such as mechanical mixture and dextran nanospheres. Especially, nanosphere containing PVA $0.2\%$ has shown nearly the zero-order release profile. As a result of this study, double layered nanospheres has more sustained release profile of drug without the initial burst and the release behavior of dexoan on tile double layered nanospheres was controlled by the contents of PVA as a surfactant.