• Title/Summary/Keyword: Release Times

Search Result 789, Processing Time 0.027 seconds

Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100 mg) (설포라제 캡슐(아세브로필린 100 mg)에 대한 부로필 캡슐의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Lim, Dong-Koo;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.3
    • /
    • pp.179-185
    • /
    • 2005
  • Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline 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 eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). 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 Surfolase, were -1.64, -3.33 and -0.92% 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

Bioequivalence of SCD Zaltoprofen Tablet to Soleton® Tablet (Zaltoprofen 80 mg) (솔레톤 정(잘토프로펜 80 mg)에 대한 삼천당잘토프로펜 정의 생물학적동등성)

  • Kang, Hyun-Ah;Park, Sun-Ae;Kim, Dong-Ho;Kim, Hwan-Ho;Yun, Hwa;Kim, Kyng-Ran;Yoo, Hee-Doo;Park, Eun-Ja;Cho, Hye-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.36 no.3
    • /
    • pp.209-215
    • /
    • 2006
  • Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ 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 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all 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, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

An Evaluation of Condensed Molasses Solubles (CMS) as a Source of Nitrogen for Ruminal Microbes In Vitro (반추위 미생물의 질소공급원으로서 Condensed Molasses Solubles (CMS)의 사료 가치 평가)

  • Yeo, J.M.;Kim, C.H.;Lee, J.H.;Nho, W.G.;Lee, S.H.;Kim, W.Y.
    • Journal of Animal Science and Technology
    • /
    • v.48 no.4
    • /
    • pp.513-520
    • /
    • 2006
  • A series of four in vitro experiments were conducted to evaluate condensed molasses solubles (CMS) as a source of nitrogen for ruminal microbes. In experiment 1, as compared with urea, the value of CMS as a nitrogen source was examined. In experiment 2, to determine the time needed for maximal response of microbial synthesis, the treatments were incubated for increasing times (from 6 h to 16 h). Because a sediment that was assumed to cause nitrogen loss was found after incubation in experiments 1 and 2, it was decided to avoid formation of sediment using sugar instead of molasses or a shorter time incubation (experiments 3 and 4). Furthermore, in experiment 4, because the extent to which ammonia nitrogen is released from CMS and urea before 6 h of incubation was uncertain, it was decided to examine the peaks of concentrations of ammonia nitrogen released from CMS and urea by sampling after 2 h incubation. There was no significant difference in the concentration of microbial-N between molasses/CMS and molasses/ urea treatments in experiment 1, although there were greater decreases in ammonia concentration with the molasses/CMS treatment. The microbial protein synthesis was increased progressively until 10 h for both treatments (experiment 2). Although ingredients that were completely soluble (sucrose, urea) were used in experiment 3, the sediment was still evident suggesting that the sediment was largely of microbial not feed origin. Ammonia release from CMS was much faster than from urea during 2 h incubation. In conclusion, the results of the present studies suggest that the feed value of CMS as a source of nitrogen for ruminal bacteria was similar to that of urea when it was estimated in vitro.

Folate Content of Fast Foods and Processed Foods (패스트푸드와 가공식품의 엽산 함량)

  • Ji, Hyun-Jung;Kim, Seung-Ki;Yon, Mi-Yong;Hyun, Tai-Sun
    • Journal of Nutrition and Health
    • /
    • v.42 no.4
    • /
    • pp.397-405
    • /
    • 2009
  • A trienzyme extraction method (use of ${\alpha}$-amylase, protease and folate conjugase) for food folate assay has been used to release folate from the food matrix. In order to reduce the incubation time with three enzymes, folate values were compared between two incubation protocols; separate incubation (SI, incubated with ${\alpha}$-amylase and conjugase separately for 2 hours after protease treatment) and combined incubation (CI, incubated with ${\alpha}$-amylase and conjugase together for 2 hours after protease treatment) using 88 food items from 12 kinds of fast foods and processed foods. We found that folate values by CI were comparable to or higher than those by SI, indicating that CI might be a better extraction procedure to shorten the entire incubation time. We measured folate contents in 49 fast foods and 26 processed foods by microbiological assay after CI. Mean folate contents of one serving of various burgers ranged from 43.1 to 62.0 ${\mu}g$. One serving of French fries, pizza, sandwich and triangled kimbab contained a mean of 53.3, 28.4, 47.4, and 25.7 ${\mu}g$ of folate, respectively. Folate contents of non-alcoholic beverages were very low, ranging from 1.0 to 5.2 ${\mu}g$/100 g. Some of our values were comparable to the values in the folate database published in Korean Nutrition Society, however, some of the published values were 140 times higher than the measured values in this study. Folate values measured by the more recent modifications here can be used to update Korean folate database to accurately estimate dietary folate intake.

Overnight Growth Hormone Secretions and Sleep Patterns in Idiopathic Short Stature Children (특발성 저신장 아동의 야간 성장호르몬 분비와 수면양상)

  • Seo, Sang Young;Lee, Kee Hyoung;Eun, Baik Lin;Sohn, Chang Sung;Tockgo, Young Chang;Shin, Chol;Kim, Baek-Hyun
    • Clinical and Experimental Pediatrics
    • /
    • v.46 no.4
    • /
    • pp.363-369
    • /
    • 2003
  • Purpose : Pharmacologic provocation test of growth hormone(GH) is a non-physiologic method and has several limitations for diagnosing growth hormone(GH) deficiency. Spontaneous GH release studies could be important in understanding the pathophysiology of children with poor growth but normal responses to GH provocation tests. Also, the relationship between nocturnal GH secretions and sleep patterns in short stature children is poorly understood. The aim of this study is to determine whether there are differences in sleep patterns and nocturnal GH secretory profiles between idiopathic short stature children and a normal stature group. Methods : Spontaneous nocturnal GH secretions and sleep patterns were evaluated in 12 prepubertal idiopathic short stature children with normal responses to provocation tests and 9 normal stature controls. Blood samples were taken every 30 minutes from 22:00-06:30 and sleep patterns were analyzed by polysomnography. Results : The mean GH level during sleep was significantly lower in short stature children than in controls. The peak GH level after sleep, coincident with the first slow wave sleep, was lower in the short stature group. The slow wave sleep times of short stature children were decreased compared with those of normal subjects. Conclusion : These results suggest that overnight serial GH sampling is helpful to identify short stature children with subnormal GH secretions, and sleep structure differences may be associated with decreased overnight GH secretions in short stature children.

Role of Wetland Plants as Oxygen and Water Pump into Benthic Sediments (퇴적물내의 산소와 물 수송에 관한 습지 식물의 역할)

  • Choi, Jung-Hyun;Park, Seok-Soon
    • Korean Journal of Ecology and Environment
    • /
    • v.37 no.4 s.109
    • /
    • pp.436-447
    • /
    • 2004
  • Wetland plants have evolved specialized adaptations to survive in the low-oxygen conditions associated with prolonged flooding. The development of internal gas space by means of aerenchyma is crucial for wetland plants to transport $O_2$ from the atmosphere into the roots and rhizome. The formation of tissue with high porosity depends on the species and environmental condition, which can control the depth of root penetration and the duration of root tolerance in the flooded sediments. The oxygen in the internal gas space of plants can be delivered from the atmosphere to the root and rhizome by both passive molecular diffusion and convective throughflow. The release of $O_2$ from the roots supplies oxygen demand for root respiration, microbial respiration, and chemical oxidation processes and stimulates aerobic decomposition of organic matter. Another essential mechanism of wetland plants is downward water movement across the root zone induced by water uptake. Natural and constructed wetlands sediments have low hydraulic conductivity due to the relatively fine particle sizes in the litter layer and, therefore, negligible water movement. Under such condition, the water uptake by wetland plants creates a water potential difference in the rhizosphere which acts as a driving force to draw water and dissolved solutes into the sediments. A large number of anatomical, morphological and physiological studies have been conducted to investigate the specialized adaptations of wetland plants that enable them to tolerate water saturated environment and to support their biochemical activities. Despite this, there is little knowledge regarding how the combined effects of wetland plants influence the biogeochemistry of wetland sediments. A further investigation of how the Presence of plants and their growth cycle affects the biogeochemistry of sediments will be of particular importance to understand the role of wetland in the ecological environment.

Behavior of amber fish, Seriola aureovittata released in the setnet (정치망내에 방류한 부시리, Seriola aureovittata 의 행동)

  • 신현옥;이주희
    • Journal of the Korean Society of Fisheries and Ocean Technology
    • /
    • v.35 no.2
    • /
    • pp.161-169
    • /
    • 1999
  • This paper describes the swimming and escaping behavior of amber fish, Seriola aureovittata released in the first bag net of the setnet and observed with telemetry techniques. The setnet used in experiment is composed of a leader, a fish court with a flying net and two bag nets having ramp net. The behavior of the fish attached an ultrasonic depth pinger of 50 KHz is observed using a prototype LBL fish tracking system. The 3-D underwater position ofthe fish is calculated by hyperbolic method with three channels of receiver and the depth of pinger. The results obtained are as follows: 1. The fish released on the sea surface was escaped down to 15 m depth and rised up to near the sea surface during 5 minutes after release. The average swimming speed of the fish during this time was 0.87 m/sec. 2. The swimming speed of the fish is decreased slowly in relation to the time elapsed and the fish showed some escaping behavior forward to the fish court staying 1 to 7 m depth layer near the ramp net. The average speed of the fish during this time was 0.52 m/sec. 3. During 25 minutes after beginning of hauling net, the fish showed a faster swimming speed than before hauling and an escaping behavior repeatedly from the first ramp net to the second one in horizontal. In vertical, the fish moved up and down between the sea surface and 20 m depth. After this time, the fish showed the escaping behavior forward to fish court after come back to the first ramp net in spite of the hauling was continued. It is found that the fish was escaped from the first ramp net to the fish court while the hauling was carried out. The average speed of the fish after beginning of hauling was 0.72 m/sec which increased 38.5 % than right before the hauling and showed 0.44 to 0.82 m/see of speed till escaping the first bag net. The average swimming speed during observation was 0.67 m/sec (2.2 times of body length).

  • PDF

Bioequivalence of Carvelol Tablet to Dilatrend Tablet (Carvedilol 25 mg) (딜라트렌 정(카르베딜롤 25 mg)에 대한 카베롤 정의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Moon-Seok;Park, Soon-Cheol;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.31 no.4
    • /
    • pp.289-295
    • /
    • 2001
  • Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Carvelol^{TM}$ (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB80 into water). Eighteen normal male volunteers, $24.22{\pm}1.86$ years in age and $64.81{\pm}4.56\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very similar at all dissolution media. Besides, 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 non-transformed and logarithmically transformed $AUC_t$ and $C_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two tablets based on the $Dilatrend^{TM}$ were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 13.55% and 17.61% for $AUC_t$ and $C_{max}$, respectively). The powers $(l-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.69{\sim}10.16$ and $-12.30{\sim}8.30$ for $AUC_t$ and $C_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.95{\sim}1.11$ and $0.89{\sim}1.09$ for $AUC_t$ and $C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Carvelol^{TM}$ tablet is bioequivalent to $Dilatrend^{TM}$ tablet.

  • PDF

Present Status of Non-Native Amphibians and Reptiles Traded in Korean Online Pet Shop (한국 온라인 펫샵에서 거래되는 외래 양서파충류 현황)

  • Koo, Kyo Soung;Park, Hye Rin;Choi, Jae Hyeok;Sung, Ha Cheol
    • Korean Journal of Environment and Ecology
    • /
    • v.34 no.2
    • /
    • pp.106-114
    • /
    • 2020
  • The development of transportation and the expansion of the pet market has become the main causes of the increase in the cross-border migration of non-native species. Moreover, recent sales over the Internet were a factor that has promoted pet trades. While the import of non-native species has been steadily increasing in the Republic of Korea, it is not clear how these imported species are traded and how large the trade is. Considering that most of the non-native species found in the wild are the results of release by humans understanding the present situation of pet trades can identify potential non-native species that can enter the wild. This study surveyed the number of species, frequency, and prices of non-native amphibians and reptiles sold in 25 online pet shops from January 22 to February 10, 2019. The results of the survey showed that a total of 677 species of non-native amphibians and reptiles were sold, and the Squamata group accounted for the largest part of them at 65.4% (443 species). The number of non-native amphibians and reptiles sold in online pet shops in 2019 was 2.1 times larger than the 325 species officially imported in 2015. The non-native amphibians and reptiles sold in most pet shops were Litoria caerulea (21 shops) and Correlophus ciliatus (24 shops). The lowest price for non-native amphibians and reptiles was 3,000 won, and the highest price was 100 million won for Rhacodactylus leachianus of Squamata. Among the non-native amphibians and reptiles sold in online pet shops, 11 species were found in the wild and were sold at relatively low prices. We confirmed that Mauremys reevesii, an endangered species class II and natural monument no. 453, and American bullfrogs (albino), an ecosystem disturbing species, were being sold in online pet shops. Moreover, 21.6% of the 677 non-native amphibians and reptiles sold in online pet shops were species designated as CITES. The results of this study can be the important reference data for understanding the status of non-native amphibians and reptiles that are imported and sold in Korea and evaluating and predicting the potential for them to enter the wild.

COATED PARTICLE FUEL FOR HIGH TEMPERATURE GAS COOLED REACTORS

  • Verfondern, Karl;Nabielek, Heinz;Kendall, James M.
    • Nuclear Engineering and Technology
    • /
    • v.39 no.5
    • /
    • pp.603-616
    • /
    • 2007
  • Roy Huddle, having invented the coated particle in Harwell 1957, stated in the early 1970s that we know now everything about particles and coatings and should be going over to deal with other problems. This was on the occasion of the Dragon fuel performance information meeting London 1973: How wrong a genius be! It took until 1978 that really good particles were made in Germany, then during the Japanese HTTR production in the 1990s and finally the Chinese 2000-2001 campaign for HTR-10. Here, we present a review of history and present status. Today, good fuel is measured by different standards from the seventies: where $9*10^{-4}$ initial free heavy metal fraction was typical for early AVR carbide fuel and $3*10^{-4}$ initial free heavy metal fraction was acceptable for oxide fuel in THTR, we insist on values more than an order of magnitude below this value today. Half a percent of particle failure at the end-of-irradiation, another ancient standard, is not even acceptable today, even for the most severe accidents. While legislation and licensing has not changed, one of the reasons we insist on these improvements is the preference for passive systems rather than active controls of earlier times. After renewed HTGR interest, we are reporting about the start of new or reactivated coated particle work in several parts of the world, considering the aspects of designs/ traditional and new materials, manufacturing technologies/ quality control quality assurance, irradiation and accident performance, modeling and performance predictions, and fuel cycle aspects and spent fuel treatment. In very general terms, the coated particle should be strong, reliable, retentive, and affordable. These properties have to be quantified and will be eventually optimized for a specific application system. Results obtained so far indicate that the same particle can be used for steam cycle applications with $700-750^{\circ}C$ helium coolant gas exit, for gas turbine applications at $850-900^{\circ}C$ and for process heat/hydrogen generation applications with $950^{\circ}C$ outlet temperatures. There is a clear set of standards for modem high quality fuel in terms of low levels of heavy metal contamination, manufacture-induced particle defects during fuel body and fuel element making, irradiation/accident induced particle failures and limits on fission product release from intact particles. While gas-cooled reactor design is still open-ended with blocks for the prismatic and spherical fuel elements for the pebble-bed design, there is near worldwide agreement on high quality fuel: a $500{\mu}m$ diameter $UO_2$ kernel of 10% enrichment is surrounded by a $100{\mu}m$ thick sacrificial buffer layer to be followed by a dense inner pyrocarbon layer, a high quality silicon carbide layer of $35{\mu}m$ thickness and theoretical density and another outer pyrocarbon layer. Good performance has been demonstrated both under operational and under accident conditions, i.e. to 10% FIMA and maximum $1600^{\circ}C$ afterwards. And it is the wide-ranging demonstration experience that makes this particle superior. Recommendations are made for further work: 1. Generation of data for presently manufactured materials, e.g. SiC strength and strength distribution, PyC creep and shrinkage and many more material data sets. 2. Renewed start of irradiation and accident testing of modem coated particle fuel. 3. Analysis of existing and newly created data with a view to demonstrate satisfactory performance at burnups beyond 10% FIMA and complete fission product retention even in accidents that go beyond $1600^{\circ}C$ for a short period of time. This work should proceed at both national and international level.