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.
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
/
v.15
no.1
/
pp.29-34
/
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.
A computeized least-cost formulation program was applied to process emulsion-type sausages. The input data in formulation were utilized with the database which had been established in the previous study. The formulation results may provide Korean meat processors with actual examples. Meat-grade system made these examples more useful. The results of manufacturing test were as follows. The actual cohesiveness from manufactured sausages didn't correspond to the predicted values, but increased as the predicted values increased. These gabs caused by the different processing conditions between the model system and the actual processing. Hardness as well as cohesiveness could be used as the desirable index of a sausage texture. Comparing the cohesiveness and hardness of commercial frankfurters with those of test sausages, bind value constraint of $0.16{\sim}0.17$ in this test formula can be utilized for an actual formulation.
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.
Journal of the Computational Structural Engineering Institute of Korea
/
v.31
no.2
/
pp.71-78
/
2018
This paper presents the assembling of multiple patches based on the single patch isogeometric formulation for the shear deformable shell element given in the previous study. The geometrically exact shell formulation has been accomplished with the shell theory based formulation and the generalized curvilinear coordinate system directly derived from the given NURBS geometry. For the knot elements matching across adjacent surfaces, the zero-th and first parametric continuity conditions are considered and the corresponding coupling constraints are implemented by a master-slave formulation between adjacent patches. The constraints are then enforced by a substitution method for condensation of the slave variables, thereby reducing the model size. Through numerical investigations, the important features of the first parametric continuity condition are confirmed. The performance of the multi-patch shell models is also examined comparing the rate of convergence of response coefficients for the zero and first order continuity conditions and continuity in coupling boundary between two patches is confirmed.
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.
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.
Transactions of the Korean Society of Mechanical Engineers
/
v.13
no.5
/
pp.820-830
/
1989
The tire inflation and contact problem has been solved by a finite element method. The finite element formulation is derived from the equilibrium equations by the principle of virtual work in the form of an updated Lagrangian formulation for incremental analysis. Then, a contact formulation is added to the finite element formulation to calculate stress state of tire in contact with flat rigid road under the load due to the self-weight of a vehicle. In the finite element analysis, equations of effective material properties are introduced to analyze a plane strain model of the shell-like tire by considering the bending effect of reinforced steel cords. The proposed equations of effective material properties produced stress concentration around the edge of belt layers, which does not appear when other well-known equations of material properties are adopted. The result from the above algorithm demonstrates the validity of the formulation and the proposed equations for the effective elastic constants. The result fully interprets the cause of separation between belt layers by showing the stress concentration.
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.
Duy-Thuc Nguyen;Min-Hwan Kim;Min-Jun Baek;Nae-Won Kang;Dae-Duk Kim
Journal of Ginseng Research
/
v.48
no.4
/
pp.417-424
/
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.
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