• Journal of Life Science
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• v.25 no.9
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• pp.1036-1042
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• 2015

By using effective sanitizers, early block for transmission of pathogens is the effective way to prevent epidermic outbreaks. Here we developed a chlorine oxide bubbling type of sanitizing tablets and evaluated the disinfectant and sanitization effects. The sanitizers showed 99.999% of sanitization effect for Escherichia coli ATCC 10536 and Staphylococcus aureus ATCC 6538 strains for 5 min±10 sec on 20±1℃ in clean condition by dilution-neutralization method. It reduced more than 5 log₁₀ cfu/ml of a legal permission standard of colony reduction. When a few used socks and underwear soaked for one hour in the 0.1% of the sanitizing tablets, no microorganisms were grown on CHROMagar plates. However, on CHROMagar plates of the no sanitizing tablets treated control, about 6.5×10⁴ cfu/ml of Staphylococcus sp., Klebsiella sp. and Enterococus sp. were grown. Furthermore, the sanitizing tablets killed approximately 1.5x10⁸ cfu/ml of E. coli BL21 in 5 minutes. Therefore, we concluded that the chlorine based bubbling type of sanitizing tablets satisfied the legal standard for the regulation of food and drug safety for disinfectants and sanitizers to pathogens and daily supplies.

• Archives of Pharmacal Research
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• v.19 no.4
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• pp.297-301
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• 1996

Plasma profile of niflumic acid following oral administration of talniflumate tablets (Somalgen) was compared to that of niflumic acid tablets in man. Plasma niflumic acid was assayed by HPLC method. Plasma niflumic acid profile from the tainiflumate tablets was similar to that from the niflumic acid tablets resulting in no differences in $AUC, C_max, t_max$ and MRT. It demonstrates that talniflumate is a prodrug of niflumic acid, and undergoes extensive first-pass biotransformation to niflumic acid. However, plasma niflumic acid concentration at 30 min after tainiflumate dosing was significantly (p<0.05) higher than that of niflumic acid dosing. The more potent analgesic activity of talniflumate than niflumic acid might be related to this higher plasma drug concentration at the earlier phase. Considering that tainiflumate is less irritant to gastrointestinal mucosa than niflumic acid, talniflumate seems to be advantageous over niflumic acid in terms of activity and side effects.

• Biomolecules & Therapeutics
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• v.11 no.2
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• pp.145-150
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• 2003

The bioequivalence of two tablet formulations of 12.72mg domperidone maleate (Sinil "$Perinal^{\circledR}$" tablets vs. Janssen Korea "Motilium-$M^{\circledR}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at spccified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\rightarrow}48},\; C_{max},\;T_{max}$ and $t_{1/2}$ were determined from plasma concentration-time profile of two formulations. Any significant statistical differences were not observed between these two formulations. On the evaluation of bioequivalence according to Korea Food and Drug Administration Guideline, 90％ confidence limits after logmithmic transformation fell within the acceptable range (log 0.8∼log 1.25). Based on these data, it can be concluded that two domperidone maleate tablets showed comparable pharmacokinetic profiles, which means that the Sinil "$Perinal^{\circledR}$" tablet is bioequivalent to the Janssen Korea ""Motilium-M$^{\circledR}$".

• Journal of Pharmaceutical Investigation
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• v.22 no.4
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• pp.281-287
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• 1992

Omeprazole (OMZ) is very unstable in acidic solution, which selectively inhibit the release of the gastric juice in the gastric mucosa, In order to stabilize (OMZ) in oral solid dosage form, the enteric-coated microcapsules and compression-coated OMZ tablets containing lysine or arginine as stabilizer were prepared and their dissolution and stability test were performed. The haif life of OMZ microcapsules containing arginine was 194 days at $30^{\circ}C$ and OMZ was completely released in 60 min. The half-lives of enteric coated and non-coated compression-coated OMZ tablets with lysine were 292 and 95 days at $30^{\circ}C$, respectively. The half-lives of enteric coated and non-coated compression-coated tablets with arginine were 1752 and 293 days at $30^{\circ}C$, respectively, and OMZ were released completely in 20 min in the 2nd fluid of K.P.VI. Consequently, the enteric-coated compression-coated OMZ tablets with arginine as stabilizer provided a good formulation for oral solid dosage form.

• Journal of Pharmaceutical Investigation
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• v.21 no.3
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• pp.171-177
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• 1991

A reverse-phase, ion-pair high performance liquid chromatographic (HPLC) method for the simultaneous quantative determination of pyridostigmine and its hydrolytic product, 3-hydroxy-N-methylpyridinium (HMP), is descrihed, The assay of pyridostigmine and HMP was linear in the range of amount from 24 to 60 mg/tablet and from 2.4 to 12.0 mg/tablet, respectively, with coefficient of variation (C.V.) of 0.05-0.12% (n=7) and 0.25-0.52% (n=5), respectively, and applicable conveniently even in the case of the mixture of pyridostigmine and HMP. Meanwhile, the conventional UV method gave inaccurate results for the aged pyridostigmine tablets. In the extraction of pyridostigmine from tablets prior to be assayed by HPLC, methanol was found to be more effective than ethanol or distilled water. Multiple extraction (four times) with methanol resulted in the full recovery of pyridostigmine, whereas ethanol gave 95% recovery even after four times extraction. Based on these results. the present method would be very useful for the accurate determination of pyridostigmine in the aged pyridostigmine tablets.

• YAKHAK HOEJI
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• v.44 no.6
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• pp.528-533
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• 2000

This study was to develop an effective itraconazole liquid preparation which exhibits an enhanced bioavailability. The solubility of itraconazole was increased (72-fold) in itraconazole liquid preparation as compared with itraconazole powder. The dissolution rate of itraconazole was higher for itraconazole liquid preparation filled into a hard gelatin capsule with 90% release within 20 min as compared to 55% for $Sporanox^{\circledR}$capsules. The oral absorption of itraconazole liquid preparation and $Sporanox^{\circledR}$tablets were studied in the rat. The area under the concentration-time curve $(AUC_{0-24hr})$ of itraconazole liquid preparation ($90.25\;{\pm}\;8.36\;{\mu}g{\cdot}hr/ml$) increased by 6.2 times compared to that of Sporanox tablets ($14.58\;{\pm}\;1.26\;{\mu}g{\cdot}hr/ml$) after oral administration of itraconazole 15 mg/rat each. $C_{max}$ also increased to $6.87\;{\pm}\;1.15\;{\mu}g/ml$ after administration of liquid preparation $1.58\;{\pm}\;0.16\;{\mu}g/ml$ of $Sporanox^{\circledR}$tablets. These results indicate that in vivo bioavailability of itraconazole liquid preparation was significantly enhanced as compared with $Sporanox^{\circledR}$tablets.

• Archives of Pharmacal Research
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• v.13 no.2
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• pp.180-186
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• 1990

A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidine for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-timecurves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum ploasma concentration at the first peak ($C_{max1}$) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline;i. e., statistical power (1-$\beta$)was calculated to be over 0.8 under the condition of $\alpha$ = 5% and $\Delta$(minimum detectable difference) = 20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of $\pm$ 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak ($C_{max2}$), and the time to reach the first ($T_{max1}$) and second verify the bioequivalence of $c_{max2}$ , $T_{max1}$ and $T_{max2}$ between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.

• YAKHAK HOEJI
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• v.60 no.2
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• pp.73-77
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• 2016

Alginic acid and carboxymethyl cellulose sodium are dietary fibers from plants. They have a swelling property and delay the gastric emptying time, thereby resulting in feeling satiated after oral administration, which may eventually contribute to loss of body weight. The goal of this study was to compare swelling property of three commercial matrix tablets based on alginic acid and carboxymethyl cellulose sodium. When the swelling was determined by the Korean Ministry of Food and Drug Safety (MFDS) guideline, the tablet prepared by direct compression method with highly viscous swelling agent showed the highest swelling in acidic conditions. Water uptake of these tablets was rapid and completed within 30 min. Moreover, when the pH was changed from 2.5 to 6.8 buffer, the water uptake was not significantly changed in all tablets.

• Journal of Pharmaceutical Investigation
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• v.27 no.2
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• pp.133-137
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• 1997

Buccal absorption test of omeprazole in human was performed to determine the permeability of the drug molecule through oral mucous membrane. Oral mucosal adhesive tablets of omeprazole were prepared by compressing the omeprazole with a mixture of sodium alginate and hydroxypropylmethyl cellulose (HPMC) as bioadhesive polymers, magnesium oxide (MgO) as a stabilizer and sodium carboxymethyl cellulose (Na CMC) or cros-carmellose sodium (Ac-Di-Sol) as disintegrants. The bioadhesive force, stability in saliva and release characteristics of the tablets were evaluated. Omeprazole was absorbed about 23% in 15 min through human buccal mucous membrane. Furthermore, omeprazole was stable in saliva for more than 8 hrs when MgO was added to the tablet as the amount of 2.5 fold of omeprazole. The release rate of omeprazole was increased with increasing the amount of sodium alginate in the tablet. From these results, it is suggested that tablets composed of [omeprazole/HPMC/sodium alginate/MgO/Ac-Di-Sol and/or Na CMC (20/6/24/50/10) (mg/tablet)] are potential candidate for buccal drug delivery system.

• The Korean Journal of Pharmacology
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• v.13 no.1 s.21
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• pp.1-6
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• 1977

The physicochemical equivalencies of drugs are not usually correlate to the generic equivalencies of drugs and the generic equivalencies of drugs produced by different manufacturers or different formulations are being called in question frequently. The bioabailability of two formulations of oxytetracycline and erythromycin stearate were performed in healthy human volunteers. At the same time, the disintegration testes were performed with randomly sampled materials in question. For the biological evaluation of new oxytetracycline formulation; tablet(250mg), two-way cross over study in 10 healthy young volunteers was performed using oxytetracycline capsule (250mg) as reference, Erythromycin stearate (250mg) tablets and capsules produced by different manufacturers were compared in a two-way cross over study in 12 subjects with same manner of oxytetracyclines. oxytetracycline tablets showed somewhat slow disintegration rate, but appeared not statistical differences in serum concentrations from the reference, up to six hours after ingestion. Erythromycin stearate capsules disintegrated more rapidly than enteric coated tablets. Serum concentrations of capsules were more variable and markedly lower (P<.005 after 2hrs) than the enteric coated tablets. Rapid disintegration of capsules may result in destruction of active chemicals owing to the interaction with gastric acid and the above factor may contribute mainly to the low serum level after ingestion of capsules.