• Advances in Traditional Medicine
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• v.7 no.5
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• pp.466-476
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• 2008

We have developed the tablet formulation of Triticum aestivum (wheatgrass) and investigated clinically, its effects in patients suffering from b-thalassemia (major) at K. T. Children Hospital, Civil Hospital, Rajkot. The tablets (wheatgrass powder 250 mg.) were given 3 times in a day for 9 months. Blood samples were collected at the start, after 6 months and 9 months and analyzed for various biochemical and hematological parameters. Treatment with wheatgrass formulation for 9 months produced significant decrease in hemoglobin, total RBC, eosinophil and reticulocyte counts. The mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC) were significantly increased was significantly increased. The serum ferritin was also significantly decreased. There was no influence on serum magnesium, serum iron and Thiobarbituric acid reacting substances (TBARS). Our data indicate that treatment with wheatgrass on patients with $\beta$-thalassemia (major) may have beneficial effects in the form of a decrease in ineffective erythropoiesis, stimulation of hemoglobin synthesis in RBC, decrease in iron load and decrease in eosinophil count.

• Journal of Microbiology and Biotechnology
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• v.12 no.5
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• pp.740-745
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• 2002

The current study was conducted to identify the differences in the rheological properties of Chlorella sp. powder cultured in a fermentor and in a pond-like environment. Cells. cultured in the same media were harvested and spray dried. The biomass yield from the fermentor culture was 4.7% (dry basis), while that from the pond was 4.3% (dry basis). Measurements of the loose bulk density, tapping test, Hausner's ratio, and compressibility test all revealed differences between the rheological properties of the Chlorella sp. from the two cultivation systems. Although both the fermentor and pond cultured Chlorella sp. showed the same angle of repose, the mean size of the cells was 2.26 $\mu\textrm{m}$ and 2.89 $\mu\textrm{m}$, respectively. The weight of the Chlorella sp. tablets cultured in the fermentor and pond was 0.663 g/tablet and 0.593 g/tablet, respectively, while the friability of the tablets was 21% and 41%, respectively. Observation by Transmission Electron Microscope (TEM) showed that the cell wall of the Chlorella sp. cultured in the fermentor was thinner and more spherical than that cultured in the pond, thereby providing the main characteristic rheological properties of the powder.

• Biomolecules & Therapeutics
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• v.10 no.3
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• pp.180-185
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• 2002

The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang Triamcinolone$\textregistered$ vs. Wyeth Korea Ledercoat$\textregistered$) was assessed in healthy male volunteers after oral administration of 16mg triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0\longrightarrowlast}$, $AUC_{0\longrightarrowinf}$ and $T_{1/2, \beta} were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to Korea Food and Drug Administration Guideline. The analysis of variance did not show any significant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang triamcinlone$\textregistered$ tablet is bioequivalent to the Wyeth Korea Ledercoat$\textregistered$ tablet.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2002.07a
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• pp.206-206
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• 2002

The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$) was assesed in healthy male Korean volunteers after oral administration of 16 mh triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0{\longrightarrow}last}$. $AUC_{0{\longrightarrow}imf}$, and $T_{1/2,\beta}$ were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to the United State or Korea Food and Drug Administration Guidelines. The analysis of variance did not show any signigicant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ tablet is bioequivalent to the $\textrm{Ledercoat}^{(R)}$ tablet produced by Wyeth Korea.

• Journal of Pharmaceutical Investigation
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• v.28 no.4
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• pp.267-274
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• 1998

Biphenyl dimethyl dicarboxylate (DDB) has been used for the treatment of acute and chronic hepatitis. However, its poor solubility in water, $2.5\;{\mu}g/ml$, caused low bioavailability of the drug after its oral administration. In order to increase the dissolution of DDB in gastrointestinal tracts, consequently to increase the bioavailability of the drug, DDB tablet was prepared with solid dispersion of DDB with poloxamer 338 or 407 using a direct compression method. To improve the flowability of the solid dispersion, Aerosil was used as an adsorbent. The effect of formulation variables (poloxamer and Aerosil contents) on the dissolution rate of DDB from tablets was investigated using an analysis of variance. The dissolution rate of DDB from tablets was evaluated with KP II (paddle) method. The dissolution patterns of the drug from the tablet prepared with poloxamer 407 were affected significantly by the contents of poloxamers and Aerosil over the range employed, but those of the drug from the tablet prepared with poloxamer 338 were not. The optimum formulation of the DDB tablet, showed the same dissolution pattern as that of the reference, was obtained after polynomial equations of drug dissolution profiles for each formula were fitted to contour plots. The optimum formulation ratios of DDB:poloxamer 407:Aerosil were 1:2.5:2.5 and 1:5:5.

• YAKHAK HOEJI
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• v.41 no.5
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• pp.595-601
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• 1997

The optimal synthesis condition based on the yield of thiamine mononitrate has been attained according to Box-wilson experimental design. The optimal condition was as follows : Molar concentration ratio of $SB1{\cdot}HCL=0.6839$, quantity of $NH_4NO_3=50.09g$, agitation velocity=51.6rpm, reaction temperature=22.8$^{\circ}C$. The stabilities of three kinds of thiamine monosalts(thiamine monoiodide, -monobromide, -monorhodanate) were investigated in sterile solution, compressed tablet and multivitamin capsule, respectively. Assay data are given to show that thiamine monosalts are not significantly higher than that of thiamine mononitrate in sterile solutions and the addition of an acidic stabilizer is unnecessary. The solutions were clear and free of precipitate and didn't discolored after storage at room temperature and 40$^{\circ}C$ for 6 months. The tablets and capsules were assayed initially and at predetermined intervals during storage at room temperature and 40$^{\circ}C$ for 6 months. Thiamine monorhodanate was found to be more stable than other thiamine monosalts in these compressed tablets containing other vitamin of the B complex and the data indicate that thiamine monosalts was similar to that of thiamine mononitrate in the multivitamine capsules.

• Archives of Pharmacal Research
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• v.17 no.2
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• pp.80-86
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• 1994

The bioavailability of digoxin generic tablets manufactures in Korea (formulations A & B) wwere compared to a standard (formulation C; Lanoxin brand digoxin, Burroughs Wellcome, USA) in 12 healthy Korean male volunteers (mean age 31.4 years) in a single dose, randomized, complete block crossover study. Using a latin square design, each of the subjects was randomized to the order number and allocated to each of the three treatments of 0.5mg oral digoxin. Digoxin conc4ntrations in serum and urine samples collected for 48 hours after dosing were measured by fluoprescence polarization immunoassy and radioimmunoassy, respectively. Treatments were compared by using nonlinear least squares regession analysis to evaluate the following pharmacokinetic parameters : maximum serum concentation $(C_{max})$; time of maximum serum concentation $(T_{max})$; area under the serum concentration-time curve $AUC_{0-12}$, $C_{max}$\;and\;(AUC_{0-12})$; and cummulative urinary excretion for 0-48 hours $(CLE_{0-48}.\;Mean\;AUC_{0-12},\;C_{max},\;and\;CUE_{0-48}$ values for formulations B and C were significantly different from formulation A (P<0.001), but not significantly diffeerent form each other. Basede on $AUL_{0-12}\;and\;CUE_{0-48}$ respectively, the relative availability of formulation B was 87.5% and 89.6% and the relative availability of formultation A was 43% and 35% when compared to formulation C(the standard).

• Bulletin of the Korean Chemical Society
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• v.35 no.2
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• pp.557-561
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• 2014

The aim of the present study was to improve dosing of lacosamide, a functionalized amino acid used as an antiepileptic agent, from twice daily to once daily for the convenience of patients. A sustained-release lacosamide tablet was developed and dissolution testing was employed to determine in vitro release behavior using water or buffer solutions at pH 1.2, 4.0, or 6.8. Lacosamide was released for 12 h from the sustainedrelease (SR) tablet, as compared to complete release within 1 h from an immediate-release $Vimpat^{(R)}$ tablet. Each formulation (100 mg) was orally administered to six beagle dogs and six mini-pigs under fasted conditions, and pharmacokinetic parameters such as the area under the concentration time curve ($AUC_t$), the maximum plasma concentration ($C_{max}$), and the time at which this occurred ($T_{max}$) were calculated. These results showed similar values for $AUC_t$, $C_{max}$, and $T_{max}$ following oral administration of immediate-release ($Vimpat^{(R)}$) and SR lacosamide tablets.

• Journal of the Korean Chemical Society
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• v.55 no.4
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• pp.620-625
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• 2011

A simple, rapid potentiometric back titration of Isoniazid (INH) in the presence of Rifampicin (RIF) in tablets and syrups is described. The method is based on the oxidation of INH by a known excess of copper (II) ion and the back titration of unreacted copper (II) ion potentiometrically with ascorbic acid using a lab-made Copper Based Mercury Film Electrode (CBMFE). The titration conditions have been optimized for the determination of 1.0-10.0 mg of INH in pure and dosage forms. The precision and accuracy of the method have been assessed by the application of lack-of-fit test and other statistical methods. Interference was not caused by RIF and other excipients present in dosage forms. Application of the method for INH assay in tablets and syrups was validated by comparison of the results of proposed method with that of the British Pharmacopoeia (BP) method using F- and t- statistical tests of significance.

• Journal of Pharmaceutical Investigation
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• v.27 no.3
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• pp.207-212
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• 1997

The bioequivalence of two nabumetone tablets was evaluated in 16 normal male volunteers $(age\;21{\sim}30\;yrs)$ following oral administration. Test product was 'Nacton tablet' made by Jin Yang Pharmaceutical Co. and reference product was 'Unimeton tablet' made by Dong Kwang Pharmaceutical Co.. After one tablet containing 500 mg of nabumetone was administered, blood was taken at predetermined time intervals and the concentration of 6-methoxy-2-naphthylacetic acid, active metabolite of nabumetone, in plasma was determined with an HPLC method using fluorescence detector. AUC, $C_{max}$ and $T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max}$ and $T_{max}$ between two products were 3.66%, 6.87% and 1.85%, respectively. The powers$(1-{\beta})$ for AUC, $C_{max}$ and $T_{max}$ were 91.4%, 88.9% and 81.1%, respectively. Detectable differences$({\Delta})$ and confidence intervals were all less than 20%. All of these parameters met the criteria of FDA for bioequivalence, indicating that "Nacton tablet" is bioequivalent to 'Unimeton tablet'.