• Title/Summary/Keyword: formulations

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Bioequivalence of Kerora Intramuscular Injections to Tarasyn Intramuscular Injections (Ketorolac Tromethamine 30 mg) (타라신 근주(케토롤락트로메타민 30 mg)에 대한 케로라 근주의 생물학적 동등성)

  • Chung, Youn-Bok;Lee, Jun-Seup;Han, Kun
    • Journal of Pharmaceutical Investigation
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    • v.29 no.1
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    • pp.67-72
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    • 1999
  • A bioequivalence study of the $Kerola^{\circledR}$ intramuscular injections (Dongkwang Pharmaceutical Co., Korea) to the $Tarasyn^{\circledR}$ intramuscular injections (Roche Co., Korea), formulations of ketorolac tromethamine (KTR), was conducted. Sixteen healthy Korean male subjects were received each formulation at the dose of 30 mg as KTR in a $2{\times}2$ crossover study. There was an one-week washout period between the doses. Plasma concentrations of KTR were monitored by a HPLC method. AUC was calculated by the linear trapezoidal method. $C_{max}$ and $T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The differences between the formulations in these parameters were all far less than 20% (i.e., 3.65, 2.59 and 4.35% for AUC, $C_{max}$ and $T_{max}$ respectively). Minimum detectable differences (%) at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were 12.87, 13.44, 20.62%, for AUC, $C_{max}$ and $T_{max}$, respectively. The 90% confidence intervals for these parameters were also within 20%. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the two formulations of KTR are bioequivalent.

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The Clinical Study on Preference of TongBiEum and GunYoEum (통비음(通痺飮)과 건요음(健腰飮)의 선호도에 대한 임상연구)

  • Lee, Kyung-min;Seo, Jung-chul;Han, Sang-won;Leem, Sung-chul;Jeong, Tae-young;Ha, Il-do;Byun, Sung-Hee
    • Journal of Acupuncture Research
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    • v.21 no.1
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    • pp.189-201
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    • 2004
  • Objective: In oriental medicine, development of new formulations has been demanded. But, there are few reports about the improvement of formulations of herbal medicine in Korea. Nowadays soft Ex has been exploited and used comparing with retort pouch. This study was designed to study on preference on TongBiEum(通痺飮)/GunYoEum(健腰飮) and to investigate which OMD(oriental medical doctor) and non-OMD prefer soft Ex or retort pouch. Methods: As pilot study we administerd TongBiEum(通痺飮) once to 30 persons who serviced Gumi Oriental Medical hospital, Daegu Haany University from April 1, 2003 to April 10, 2003. And then we administerd GunYoEum(健腰飮) once to final test group(73 persons) who serviced Daegu, Gumi, Pohang Oriental Medical hospital, Daegu Haany University from April 20, 2003 to May 10, 2003. We made up questionaires about feeling during and after taking medicine, convenience and preference ect. Results: Convenience and preference of soft Ex is significantly different between OMD and non-OMD and in age bracket, but there is no significance between men and women group. Portable state of soft Ex is very convenient, dose of soft Ex is a little amount, color of soft Ex is regular in OMD & non-OMD, men & Women and an age bracket. Conclusions: From above study it was revealed that preference of herbal medicine formulations was significantly different between OMD and non-OMD. So development of new herbal medicine formulations is needed for consumers such as non-OMD.

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Herbicidal efficacy of various formulations and application timings of imazosulfuron+fentrazamide mixtures in rice (벼 재배에서 imazosulfuron+fentrazamide 합제의 제형 및 처리시기에 따른 제초활성)

  • Kang, Kwang Sik;Won, Ok Jae;Park, Su Hyuk;Eom, Min Yong;Hwang, Ki Seon;Suh, Su Jeong;Pyon, Jong Yeong;Park, Kee Woong
    • Korean Journal of Agricultural Science
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    • v.41 no.1
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    • pp.17-22
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    • 2014
  • This study was conducted to evaluate the efficacy of formulations and application timings of imazosulfuron+fentrazamide in rice field. Weeding efficacy of imazosulfuron+fentrazamide SC (75+300 g a.i./ha) was more than 95% except Bidens tripartita. The efficacy of this formulation was not related to its formulations but was highly related to application timing. Herbicide application before 5 days after transplanting was best timing to get a maximum weed control. Systemic application before and after transplanting was much higher than single application for weed control. Second leaf stage of Echinochloa spp. and sulfonylurea resistant Monochoria vaginalis was controled over 90% in the imazosulfuron+fentrazamide SC (75+300 g a.i./ha). Based on these data, imazosulfuron+fentrazamide can be applied to provide effective weed control especially in the field infested with herbicide resistant M. vaginalis.

Growth Response of Kentucky Bluegrass and Creeping Bentgrass by Foliar Spray with Chitosan Formulation and Seaweed Extracts during Fall Season (키토산 제형과 해조추출물의 엽면살포가 가을철 Kentucky Bluegrass와 Creeping Bentgrass의 생육 반응)

  • Chang, Tae-Hyun;Yoon, Jeong-Ho
    • Asian Journal of Turfgrass Science
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    • v.25 no.2
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    • pp.195-201
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    • 2011
  • The seaweed (Ascophyllum nodosum) extracts and chitosan formulations were sprayed on species of creeping bentrgass (Agrostis palustris Huds) cultivar "Penn A1" and species of Kentucky bluegrass (Poa pratensis L.) mixed cultivars (Midnight 33%, Moonlight 33%, Prosperity 33%) during fall season in sod farm. Turf color, chlorophyll contents and NDVI (Normalized Difference Vegetation Index) to affect turf qualities were investigated. There were detected significantly difference on chlorophyll contents and DNVI with seaweed extracts and chitosan formulations treatments. The contents of chlorophyll and NDVI on species of Kentucky bluegrass mixed cultivars and species of creeping bentgrass cultivar "Penn A1" were significantly increased by foliar spray with chitosan formulations and seaweed extracts. There was not a significantly difference on leaf color in two species within cultivars. These results suggested that chitosan formulations and seaweed extracts may help for turfgrass managements in the golf course during fall season.

Studies on Composites Using Wood and Nonwood Fibers - Effects of Polypropylene Fiber Length and Process Variables - (목질(木質)과 비목질계(非木質系) 섬유(纖維)를 활용한 복합재(複合材) 연구(硏究) - 폴리프로필렌의 섬유장(纖維長)과 공정변수(工程變數)의 영향(影響)을 중심(中心)으로 -)

  • Lee, Phil-Woo
    • Journal of the Korean Wood Science and Technology
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    • v.25 no.2
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    • pp.33-44
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    • 1997
  • This study was executed to examine the effects of polypropylene fiber length and process variables of the composites made from wood fiber and nonwood fiber mixed formulations. As a nonwood fiber the polypropylene with 3 denier thickness of tow condition was selected and cut into each length of 0.5, 1.0, 1.5, 2.0 and 2.5cm to mix with wood fiber. And also western hemlock wood fiber for medium density fiberboard was prepared. First, to decide an adequate polypropylene mixing fiber length, the composites of 1.0g/$cm^3$ density were made from 10% polypropylene fiber by each of five lengths and 90% western hemlock fiber mixed formulations. Thereafter as the experiments of process variable, the composites applied with adequate polypropylene fiber length(1.5cm) were made from 4 density levels (0.6, 0.8, 1.0, 1.2g/$cm^3$). 3 mixed formulations of wood fiber to polypropylene fiber(95 : 5, 90 : 10, 85 : 15), and 3 mat moisture contents(5, 10, 20%). According to the results and discussions it was concluded as follows ; The physical and mechanical properties were shown improved tendency. as polypropylene fiber length was increased in the range from 0.5 to 1.5cm, but shown decreasing tendency from 2.0 to 2.5 cm. Accordingly, it was shown that polypropylene fiber length is limited to 1.5cm or less length in mixing wood fiber and polypropylene fiber by turbulent air mixing process. As the densities of wood fiber-polypropylene fiber composites were increased, the physical and mechanical properties were clearly improved. Also they were shown significantly increasement statistically between densities respectively. In the mixed formulations, physical and mechanical properties were shown only slightly improvement, as they changed from 95 : 5 to 85 : 15 in wood fiber to polypropylene fiber. Despite of increasement of mat moisture content, mechanical properties were not improved significantly but physical properties were improved somewhat in wood fiber-polypropylene fiber composites.

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HF-IFF: Applying TF-IDF to Measure Symptom-Medicinal Herb Relevancy and Visualize Medicinal Herb Characteristics - Studying Formulations in Cheongkangeuigam - (HF-IFF: TF-IDF를 응용한 병증-본초 연관성(relevancy) 측정과 본초 특성의 시각화 -청강의감 방제를 대상으로-)

  • Oh, Junho
    • The Korea Journal of Herbology
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    • v.30 no.3
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    • pp.63-68
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    • 2015
  • Objectives : We applied the term weighting method used in the field of data search to quantify relevancy between symptoms and medicinal herbs, and, based on this, we aim to introduce a method of visualizing the characteristics of medicinal herbs. Methods : We proposed HF-IFF, an adaptation of TF-IDF, which is a term weighting measurement method adapted in the field of data search. Using this method, we deduced relevancy between symptoms and medicinal herbs In Cheongkangeuigam that was published in 1984 by organizing the medical theory of Cheongkang, Kim Younghoon, and visualized this as a graph in order to compare the characteristics of medicinal herbs used for different symptoms. Results : HF-IFF is the product of HF and IFF, where HF is the frequency of the relevant medicinal herb for a set of symptoms, and IFF is the inverse of the number of formulations (FF) containing that herb. A total of 251 types of medicinal herb are used in Cheongkangeuigam, and 1538 formulations are classified according to 67 types of symptom. The overall mean for HF-IFF was 0.491, with a maximum of 4.566 and a minimum of 0.013. Conclusions : In spite of several limitations, we were able to use HF-IFF to measure relevancy between symptoms and medicinal herbs, with formulations as an intermediate. We were able to use the quantified results to visually express the characteristics of the herbs used for symptoms by bubble chart and word-cloud from HF-IFF.

Bioequivalence of Ramiprin® tablet to Tritace Protect® tablet (Ramipril 10 mg) (트리테이스프로텍트 ®정(라미프릴 10mg)에 대한 라미프린 ®정의 생물학적동등성)

  • Oh, Soo-Yeon;Cho, Jong-Tae;Kim, Hyung-Gun;Kim, Yoon-Gyoon
    • Journal of Pharmaceutical Investigation
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    • v.38 no.1
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    • pp.73-78
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    • 2008
  • To evaluate the bioequivalence of two ramipril formulations, a standard 2-way randomized cross-over study was conducted in twenty-six healthy male Korean volunteers. A single oral dose of 10 mg of test formulation $Ramiprin^{(R)}$ (tablet) or reference formulation Tritace $Protect^{(R)}$ (tablet) was administered with one-week washout period. Plasma concentrations of ramipril were assayed over a period of 12 hr with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The values of area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$ were $77.45{\pm}44.78\;and\;78.96{\pm}45.64$ for test, and $70.30{\pm}42.27\;and\;71.99{\pm}43.55ng\;hr/mL$ for reference formulation, respectively. Similarly, maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $65.61{\pm}19.96ng/mL$ and $2.15{\pm}0.75hr$ for test, and $63.63{\pm}25.50ng/mL$ and $2.16{\pm}0.73hr$ for reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ for the test and the reference, were $0.51{\pm}0.22hr\;and\;0.52{\pm}0.18hr$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log-transformed values of $AUC_t\;and\;C_{max}$ were 1.03 to 1.19 and 0.98 to 1.17, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribed interchangeably.

Simulation of Moving Storm in a Watershed Using A Distributed Model -Model Development- (분포형 모델을 이용한 유역내 이동강우(MOVING STORM)의 유출해석(1) -모델의 개발-)

  • Choe, Gye-Won;Lee, Hui-Seong;An, Sang-Jin
    • Water for future
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    • v.25 no.1
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    • pp.101-110
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    • 1992
  • In this paper for simulating spatially and temporally varied moving storm in a watershed a distributed model was developed. The model is conducted by two major flow simulations which overland flow simulation and channel network flow simulation. Two dimensional continuity equation and momentum equation of kinematic approximation are used in the overland flow simulation. On the other hand, in the channel networks simulation two types of governing equations which are one dimensional continuity and momentum equations between two adjacent sections in a channel, and continuity and energy equations at a channel junction are applied. The finite element formulations were used in the overland flow simulation and the implicit finite difference formulations were used in the channel network simulation. The finite element formulations for the overland flow are analyzed by the Gauss elimination method and the finite difference formulations for the channel network flow are analyzed by the double sweep method having advantages of computational speed and reduced computer storages. Several recurrent coefficient equations for channel network simulation are suggested in the paper.

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Statatistical Analysis of Three Sequence-Three Periods Bioequivalence Study : Application to Bioequivalence Test of Ondansetron Formulations ($3{\times}3$ 라틴 방격법 모델에 따른 생물학적 동등성 시험의 통계 해석 : 온단세트론 제제에 대한 적용 예)

  • Lee, Young-Joo;Lee, Myung-Gull;Chung, Suk-Jae;Lee, Min-Hwa;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.28 no.1
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    • pp.35-42
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    • 1998
  • A $3{\times}3$ Latin square crossover study for the bioequivalence of three ondansetron formulations was conducted. Test products were $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg tablets and reference product was $Zofran^{\circledR}$ tablet. Twenty one healthy Korean male subjects received each formulation at the ondansetron dose of 8 mg and plasma concentrations of ondansetron were monitored by HPLC for over a period of 12 hr after the oral administration. Statistical procedure for bioequivalence evaluation of AUC {e.g., analysis of variance (ANOVA), multiple comparison and confidence intervals} was carried out. There were no significant differences in AUC among the formulations. The confidence intervals for the AUC of $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg were between -0.24 and 15.54% and between -2.41 and 13.36% respectively, within a range that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence. These statistical procedure could be standardized and generally applicable for the assessment of bioequivalence for multiple (more than two) formulations.

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Evaluation of Skin Absorption of Catechin from Topical Formulations Containing Korean Pine Bark Extract (Pinexol®) (국산 소나무껍질추출물(파인엑솔®)을 함유한 제제의 피부흡수 평가)

  • Choi, Joon-Ho;Choi, Min-Koo;Han, Ohan-Taek;Han, Sung-Jeong;Chung, Suk-Jae;Shim, Chang-Koo;Kim, Dae-Duk
    • Journal of Pharmaceutical Investigation
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    • v.37 no.6
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    • pp.359-364
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    • 2007
  • Pine bark extract is well-known as a very powerful antioxidant, anti-inflammatory, and antibiotic material. French maritime pine bark extract ($Pycnogenol^{(R)}$) of Horphag Research has monopolized the world market over 30 years. Korean red pine bark extract ($Pinexol^{(R)}$) was first manufactured by the patent technology of NutraPharm in Korea in 2006. Feasibility of topical gel and patch formulations of Pinexol was systematically investigated by evaluating the skin absorption of catechin as a reference compound. In vitro hairless mouse skin absorption of catechin from gel formulation was higher than that from patches. However, significant amount of catechin was also deposited inside the skin from patch formulations, which were dependent on the types of pressure sensitive adhesives. Thus, it seems to be feasible to control the topical delivery of Pinexol by using both gel and patch formulations, and be necessary to conduct further systematic investigation.