• 제목/요약/키워드: Formulation.

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Bioequivalence Assessment of Nabumetone Tablets in Healthy Korean Volunteers

  • Park, Moon-Hee;Shin, In-Chul
    • Biomolecules & Therapeutics
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    • 제15권2호
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    • pp.118-122
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    • 2007
  • This study was performed to evaluate the bioequivalency between the Osmetone$^{TM}$ Tablet (Myeongmoon Pharm. Co., Ltd.) as a test formulation and the Relafen$^{TM}$ Tablet (Handok Pharm. Co., Ltd.) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with Ultra-Violet (UV) detector. AUC$_t$, C$_{max}$ and T$_{max}$ were obtained from the time-plasma concentration curves, and log-transformed AUC$_t$ and C$_{max}$ and log-untransformed T$_{max}$ values for two formulations were compared by statistical tests and analysis of variation. AUC$_t$ was determined to be 897.8${\pm}$431.1 ug.hr/ml for the reference formulation and 902.3${\pm}$408.4 ug.hr/ml for the test formulation. The mean values of C$_{max}$ for the reference and test formulations were 24.2${\pm}$8.9 and 24.0${\pm}$9.5 ug/ml, respectively. The AUC$_t$ and C$_{max}$ ratios of the reference Relafen$^{TM}$ Tablet to the test Osmetone$^{TM}$ Tablet were +5.01% and -0.83%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for logtransformed AUC$_t$ and C$_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for AUC$_t$ and C$_{max}$ were located in ranges from log 0.80 to log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The Osmetone$^{TM}$ Tablet as the test formulation was considered to be bioequivalant to the Relafen$^{TM}$ Tablet used as its reference formulation, based on AUC$_t$ and C$_{max}$ values.

Development of W/O/W Multiple Emulsion Formulation Containing Burkholderia gladioli

  • KIM, HWA-JIN;CHO, YOUNG-HEE;BAE, EUN-KYUNG;SHIN, TAEK-SU;CHOI, SUNG-WON;CHOI, KEE-HYUN;PARK, JI-YONG
    • Journal of Microbiology and Biotechnology
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    • 제15권1호
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    • pp.29-34
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    • 2005
  • W/O/W (water-in-oil-in-water) type multiple emulsion was applied to improve the storage stability of an antagonistic microorganism, Burkholderia gladioli. Encapsulation of microorganism into a W/O/W emulsion was conducted by using a two-step emulsification method. W/O/W emulsion was prepared by the incorporation of B. gladioli into rapeseed oil and the addition of polyglycerin polyriconolate (PGPR) and castor oil polyoxyethylene (COG 25) as the primary and secondary emulsifier, respectively. Microcrystalline cellulose was used as an emulsion stabilizer. To evaluate the usefulness of W/O/W emulsion formulation as a microbial pesticide for controlling the bacterial wilt pathogen (Ralstonia solanacearum), the storage stability and antagonistic activity of emulsion formulation were tested in vitro. The storage stability test revealed that the viability of formulated cells in emulsion was higher than that of unformulated cells in culture broth. At $4^{\circ}C$, the viabilities of formulated cells and unformulated cells at the end of 20 weeks decreased to about 2 and 5 log cycles, respectively. At $37^{\circ}C$, the viability of formulated cells decreased to only 2 log cycles at the end of storage. On the other hand, the viable cells in culture broth were not detected after 13 weeks. In activity test, formulated cells in emulsion were more effective in inhibiting the growth of pathogen than unformulated cells in culture broth. Unformulated cells completely lost their antagonistic activity during storage under similar conditions. The W/O/W multiple emulsion formulation was shown to be useful as the novel liquid formulation for biological control.

유화형 소시지 제조시 컴퓨터를 이용한 최소가격배합프로그램의 적용 (Application of a Computerized Least-Cost Formulation in Processing an Emulsion-Type Sausage)

  • 남기창;이무하
    • 한국식품과학회지
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    • 제25권5호
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    • pp.481-486
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    • 1993
  • 본 연구는 유화형 소시지 제조시 전보에서 분석된 원료육의 성분과 기능성 자료를 데이타베이스로 하여, 컴퓨터를 이용한 최소가격배합을 자성하여 그 적용의 실례를 들고 제한조건의 하나로 설정된, 결착지수의 부합도를 실제 제품제조를 통해 검토한 후 적정 결착지수 제한조건을 찾기 위하여 실시하였다. 결착지수 제한조건을 달리하여 최소가격배합비로 제조한 프랑크푸르터소시지의 실측 결착성을 측정한 결과 예측치와 일치하지는 않았으나 비례하여 나타났으며, 일치하지 않은 이유는 결착지수가 모형시스템에 의해서 구해진 관계로 실제 제조공정과 조건이 다른 것으로 사려된다. 또한 조직감 분석대상들을 결착지수와 비교했을 때 소시지의 조직감을 표현하는 바람직한 지표로서 cohesiveness와 함께 hardness를 동시에 고려할 필요가 있었다. 시중 제품의 결착성과 경도를 고려하여 볼 때 본 연구의 결착지수 제한조건은 $0.16{\sim}0.17$로 설정될 수 있었다.

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Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers

  • Kwon Oh-Seung;Kim Hye-Jung;Pyo Hee-Soo;Chung Youn-Bok
    • Biomolecules & Therapeutics
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    • 제14권1호
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    • pp.50-55
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    • 2006
  • The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

다중 패치 쉘 아이소 지오메트릭 해석의 계면 연속성 검토 (Studies of Interface Continuity in Isogeometric Structural Analysis for Multi-patch Shell Components)

  • 하윤도;노정민
    • 한국전산구조공학회논문집
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    • 제31권2호
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    • pp.71-78
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    • 2018
  • 본 연구에서는 NURBS 기반 아이소 지오메트릭 쉘 해석을 위해 다중 패치 해석 모델을 정식화하였다. 기존 연구를 통해 개발된 단일 패치로 구성된 전단 변형을 고려한 쉘 요소에 대해 일반 좌표계에서 기하학적으로 엄밀한 쉘 구조물의 아이소 지오메트릭 해석 모델을 도입하고 매개변수 연속성을 고려하여 다중 패치 모델로 확장하였다. 인접 곡면의 노트 요소가 결합 경계를 통해 조화를 이루는 경우에 대해 0차와 1차 매개변수 연속성 조건을 고려하였으며, 두 패치 간 마스터-슬레이브 관계를 정립하여 종속된 한 곡면의 자유도를 상대 곡면의 자유도로 표시하여 모델 크기를 줄이면서 두 곡면을 결합하였다. 다중 패치 쉘 예제에 대해 0차와 1차 연속성 조건을 각각 적용하여 구조해석을 수행하여 1차 연속성 조건의 주요한 특성들을 확인하였다. 또한 각 연속성 조건에 대한 해의 수렴 특성을 검토하였으며 결합 경계에서의 두 패치의 연속성을 확인하였다.

Optimization Study on the Formulation of Roxithromycin Dispersible Tablet Using Experimental Design

  • Weon, Kwon-Yeon;Lee, Kyung-Tae;Sunseo, Sung-Hoon
    • Archives of Pharmacal Research
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    • 제23권5호
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    • pp.507-512
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    • 2000
  • This study set out to improve the physical and pharmaceutical characteristics of the present formulation using an appropriate experimental design. The work described here concerns the formulation of the dispersible tablet applying direct compression method containing roxithromycin in the form of coated granules. In this study $2^3$ factorial design was used as screening test model and Central Composite Design (CCC) associated with response surface methodology was used as optimization study model to develop and to optimize the proper formulation of roxithromycin dispersible tablet. The three independent variables investigated were functional excipients like binder (X1), disintegrant (X2) and lubricant (X3). The effects of these variables were investigated on the following responses: hardness (Y1), friability (Y2) and disintegration time (Y3) of tablet. Three replicates at the center levels of the each design were used to independently calculate the experimental error and to detect any curvature in the response surface. This enabled the best formulations to be selected objectively. The effect order of each term to all response variable was X3> X2> Xl> X1*X2> X2*X2> X2*X3> X3*X3> Xl*X3> Xl*Xl and model equations on each response variables were generated. Optimized compositions of formula were accordingly computed using those model equations and confirmed by following demonstration study. As a result, this study has demonstrated the efficiency and effectiveness of using a systematic formulation optimization process to develop the tablet formulation of roxithromycin dispersible tablet with limited experiment.

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Isolation and Identification of Burkholderia pyrrocinia CH-67 to Control Tomato Leaf Mold and Damping-off on Crisphead Lettuce and Tomato

  • Lee, Kwang-Youll;Kong, Hyun-Gi;Choi, Ki-Hyuck;Lee, Seon-Woo;Moon, Byung-Ju
    • The Plant Pathology Journal
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    • 제27권1호
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    • pp.59-67
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    • 2011
  • A bacterial strain CH-67 which exhibits antagonism towards several plant pathogenic fungi such as Botrytis cinerea, Fulvia fulva, Rhizoctonia solani, Sclerotinia sclerotiorum, Colletotrichum sp. and Phytophthora sp. was isolated from forest soil by a chitin-baiting method. This strain was identified as Burkholderia cepacia complex (Bcc) and belonging to genomovar IX (Burkholderia pyrrocinia) by colony morphology, biochemical traits and molecular method like 16S rRNA and recA gene analysis. This strain was used to develop a bio-fungicide for the control of tomato leaf mold caused by Fulvia fulva. Various formulations of B. pyrrocinia CH-67 were prepared using fermentation cultures of the bacterium in rice oil medium. The result of pot experiments led to selection of the wettable powder formulation CH67-C containing modified starch as the best formulation for the control of tomato leaf mold. CH67-C, at 100-fold dilution, showed a control value of 85% against tomato leaf mold. Its disease control efficacy was not significantly different from that of the chemical fungicide triflumidazole. B. pyrrocinia CH-67 was also effective in controlling damping-off caused by Rhizoctonia solani PY-1 in crisphead lettuce and tomato plants. CH67-C formulation was recognized as a cell-free formulation since B. pyrrocinia CH-67 was all lethal during formulation process. This study provides an effective biocontrol formulation of biofungicide using B. pyrrocinia CH-67 to control tomato leaf mold and damping-off crisphead lettuce and tomato.

타이어 접지문제의 유한요소 응력해석 (Finite Element Analysis of the Tire Contact Problem)

  • 한영훈;김용희;허훈;곽윤근
    • 대한기계학회논문집
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    • 제13권5호
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    • pp.820-830
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    • 1989
  • 본 논문에서는 타이어의 각 부분의 물성치 계산을 위한 식을 유한요소법에 적용할 수 있도록 제안하였다. 이 식은 강철 코드의 굽힙효과를 고려 하였으며, 특히 각 요소에서 전단변형이 일어나는 동안의 굽힘효과를 고려하였다. 유한요소 공식화는 가상일의 원리에 의하여 평형 방정식으로부터 유도하였고, Updated refer- ence coordinate에 대해 증분해석을 적용하여 Updated Lagrangian공식화를 하였다. 그리고 차량하중에 의하여 타이어가 노면에 접지될때의 응력상태를 게산할 수 있도록 접촉문제 공식화를 유한요소 공식화에 첨가 하였다.

Lateral torsional buckling of steel I-beams: Effect of initial geometric imperfection

  • Bas, Selcuk
    • Steel and Composite Structures
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    • 제30권5호
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    • pp.483-492
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    • 2019
  • In the current study, the influence of the initial lateral (sweep) shape and the cross-sectional twist imperfection on the lateral torsional buckling (LTB) response of doubly-symmetric steel I-beams was investigated. The material imperfection (residual stress) was not considered. For this objective, standard European IPN 300 beam with different unbraced span was numerically analyzed for three imperfection cases: (i) no sweep and no twist (perfect); (ii) three different shapes of global sweep (half-sine, full-sine and full-parabola between the end supports); and (iii) the combination of three different sweeps with initial sinusoidal twist along the beam. The first comparison was done between the results of numerical analyses (FEM) and both a theoretical solution and the code lateral torsional buckling formulations (EC3 and AISC-LRFD). These results with no imperfection effects were then separately compared with three different shapes of global sweep and the presence of initial twist in these sweep shapes. Besides, the effects of the shapes of initial global sweep and the inclusion of sinusoidal twist on the critical buckling load of the beams were investigated to unveil which parameter was considerably effective on LTB response. The most compatible outcomes for the perfect beams was obtained from the AISC-LRFD formulation; however, the EC-3 formulation estimated the $P_{cr}$ load conservatively. The high difference from the EC-3 formulation was predicted to directly originate from the initial imperfection reduction factor and high safety factor in its formulation. Due to no consideration of geometric imperfection in the AISC-LFRD code solution and the theoretical formulation, the need to develop a practical imperfection reduction factor for AISC-LRFD and theoretical formulation was underlined. Initial imperfections were obtained to be more influential on the buckling load, as the unbraced length of a beam approached to the elastic limit unbraced length ($L_r$). Mode-compatible initial imperfection shapes should be taken into account in the design and analysis stages of the I-beam to properly estimate the geometric imperfection influence on the $P_{cr}$ load. Sweep and sweep-twist imperfections led to 10% and 15% decrease in the $P_{cr}$ load, respectively, thus; well-estimated sweep and twist imperfections should considered in the LTB of doubly-symmetric steel I-beams.

Preparation and evaluation of proliposomes formulation for enhancing the oral bioavailability of ginsenosides

  • Duy-Thuc Nguyen;Min-Hwan Kim;Min-Jun Baek;Nae-Won Kang;Dae-Duk Kim
    • Journal of Ginseng Research
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    • 제48권4호
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    • pp.417-424
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    • 2024
  • Background: This research main objective was to evaluate a proliposomes (PLs) formulation for the enhancement of oral bioavailability of ginsenosides, using ginsenoside Rg3 (Rg3) as a marker. Methods: A novel PLs formulation was prepared using a modified evaporation-on-matrix method. Soy phosphatidylcholine, Rg3-enriched extract, poloxamer 188 (Lutrol® F 68) and sorbitol were mixed and dissolved using a aqueous ethanolic solution, followed by the removal of ethanol and lyophilization. The characterization of Rg3-PLs formulations was performed by powder X-ray diffractometry (PXRD), transmission electron microscopy (TEM) and in vitro release. The enhancement of oral bioavailability was investigated and analyzed by noncompartmental parameters after oral administration of the formulations. Results: PXRD of Rg3-PLs indicated that Rg3 was transformed from crystalline into its amorphous form during the preparation process. The Rg3-encapsulated liposomes with vesicular-shaped morphology were generated after the reconstitution by gentle hand-shaking in water; they had a mean diameter of approximately 350 nm, a negative zeta potential (- 28.6 mV) and a high entrapment efficiency (97.3%). The results of the in vitro release study exhibited that significantly more amount of Rg3 was released from the PLs formulation in comparison with that from the suspension of Rg3-enriched extract (control group). The pharmacokinetic parameters after oral administration of PLs formulation in rats showed an approximately 11.8-fold increase in the bioavailability of Rg3, compared to that of the control group. Conclusion: The developed PLs formulation could be a favorable delivery system to improve the oral bioavailability of ginsenosides, including Rg3.