• Korean Journal of Clinical Pharmacy
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• v.3 no.1
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• pp.79-88
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• 1993

Bioequivalence(BE) test of commercially available sustained release tablets of diltiazem hydrochloride(DTZ) was performed to give some guidelines to BE test in korea in case of which drugs with low oral bioavaiiability(BA) due to substantial first-pass hepatic loss form pharmacologically active metabolites. In such cases, the pharmacologic activity after oral administration is greater than anticipated from BA data, based on chemical assay of drug alone. Therefore, this paper explores the use and meaning of area under the plasma concentration-time(AUC) data of parent and its metabolites to access BA if sustained release tablets. Normal healthy male volunteers(n=14) were randomly divided into 2 groups, and sustained release reference$(Herbesser^{(R)})$ and test$(Herben^{(R)})$ tablets of DTZ-30mg were given orally by balanced two-period cross-over dosing schedule. The plasma concentration of DTZ and and its active metabolite, desacetyldiitiazem(DAD), were determined by high performance liquid chromatography, and, $AUC_{DTZ},\;AUC_{DAD},\;AUC_{DTZ+DAD},\;C_{max}\;and\;T_{max}$ obtained. Analysis of varlance(ANOVA) showed that $AUC_{DTZ}\;and\;C_{max}$ passed the standard $(\alpha=0.05,\;1-\beta\geq0.8,\;\Delta\leq0.2)$ of BE test of korea, but $AUC_{DAD}$ was not satisfied from the standpoint of power. On the other hand, $AUC_{DTZ\midDAD}$ may be more avaliable than $AUC_{DAD}$ from the standpoint of statistics and pharmacologic equivalence.

• Korean Journal of Clinical Pharmacy
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• v.10 no.1
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• pp.25-29
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• 2000

Bioequivalence of cisapride-containing $Cisaplus^{(R)}$ tablets (Daewoong Co.) to reference $Prepulsid^{(R)}$ tablets (Janssen Co.) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered orally at a cisapride dose of 10 mg in a $2\times2$ crossover design. There was a 1-week washout period between the treatments. Blood samples were taken at predetermined time intervals for 48 hr and the plasma cisapride concentrations were determined by an HPLC with UV detector. The area under the plasma drug concentration-time curve (AUC) was caltulated from time zero to the last sampling time by a linear trapezoidal method. The maximum observed plasma drug concentration ($C_{max}$) and the time to $C_{max}\;(T_{max})$ were estimated directly from the drug concentration-time data. Analysis of variance (ANOVA) showed that the apparent differences for AUC, $C_{max}\;and\;T_{max}$ were $-7.52\%,\;-8.91\%\;and\;-15.55\%$, respectively. The minimum detectable differences for AUC, $C_{max}\;and\;T_{max}$ between formulations were $14.52\%,\;11.57\%\;and\;28.00\%$ respectively, at $\alpha=0.05\;and\;1-\beta=0.8\;levels.\;The\;90\%$ confidence intervals for AUC, $C_{max}\;and\;T_{max}\;were\;-16.00\sim0.97\%,\;-15.67\sim-2.15\%\;and\;-31.88\%\sim0.84\%$, respectively. These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cisapride are bioequivalent.

• YAKHAK HOEJI
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• v.56 no.4
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• pp.211-216
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• 2012

Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

• YAKHAK HOEJI
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• v.55 no.5
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• pp.419-425
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• 2011

To secure the good quality of pharmaceutical products, dissolution specifications for Octylonium bromide tablets and Pinaverium bromide tablets are needed to be established, which are enrolled in KPC (Korea Pharmaceutical Codex) with having no appropriate specifications. For establishing dissolution specifications, a number of experiments based on the "Guideline of Dissolution Testing for Solide Oral Dosage Forms" were performed. The results of this study will be used for revising KPC and it is expected to contribute to the incessant production of quality ensured drugs.

• Journal of the Korean Society of Visualization
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• v.19 no.3
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• pp.84-91
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• 2021

Effervescent tablets generate gas bubbles when chemical reaction occurs between water and tablets. Most of previous studies have been focused on pharmaceutical characteristics of tablets. However, for their applications in disinfectants, cleaners, and pesticides, physical characteristics of bubbles released from the effervescent tablets when they are in water are important. In this study, we experimentally investigated the characteristics of microbubbles generated by an effervescent tablet made of sodium bicarbonate and tartaric acid using PDPA and high-speed camera. Microbubbles were generated using different weights of effervescent tablet as well as in different water temperature. The experimental study shows increase in reaction time, bubble concentration and rise velocity as the weight of effervescent tablet increases from 1 to 20 g. The decrease in average bubble diameter was observed when the temperature of water increased from 25 to 45 ℃. Further, reaction time varies inversely with increase in water temperature, while bubble rise velocity is directly proportional to increase in water temperature. Effervescent table continuously generates the bubble with approximately constant diameter (235 ㎛) in the water. However, bubble concentration and bubble rise velocity decreased over time.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.23
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• pp.10445-10449
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• 2015

Objective: To observe treatment effects and safety of fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain. Methods: Patients confirmed pathologically with cancer and complicated with moderate to severe pain, were divided into control and experimental groups. Oxycodone prolonged-release tablets, with or without fluvoxamine, were administrated to all study patients until pain relief. Degree of pain relief, dose of oxycodone prolonged-release tablets, side effects and quality of life were compared before and after treatment. Results: In total, 120 patients were recruited. No statistically significant difference was detected regarding age, gender, types of cancer, KPS between two groups of patients (P>0.05). Baseline pain score of patients with moderate pain in treatment and control group was $4.9{\pm}0.8$ and $5.1{\pm}0.8$, respectively; and decreased to $1.8{\pm}1.1$ and $1.2{\pm}1.1$ after treatment, respectively. Pain intensity was significantly reduced in the treatment group (P=0.028). Average daily consumption of oxycodone prolonged-release tablets was ($54.0{\pm}19.6$) mg and ($44.7{\pm}18.7$) mg respectively, which is lower in treatment grpup than in control group, but the difference was not statistically significant (P=0.065). Baseline pain score of patients with severe pain in treatment and control groups were $8.3{\pm}1.1$ and $8.3{\pm}1.1$, respectively; and pain intensity after treatment decreased to $2.9{\pm}1.0$ and $2.3{\pm}1.0$. Pain intensity was significantly reduced in the treatment group, with statistical significance (P=0.026). Average daily consumption of oxycodone prolonged-release tablets was ($132.0{\pm}42.2$) mg and ($110.7{\pm}33.9$) mg, respectively, which is lower in treatment group than in control group, and the difference was statistically significant (P=0.035). In terms of quality of life, patients in treatment group had better performance status, daily activity, mood, and sleep than that in control group (P < 0.05). Patients in two groups had similar side effects, eg., constipation, nausea/vomiting, lethargy, dizziness, itchy skin, dysuria, and ataxia. Lower incidence of nausea/vomiting, lethargy, was obtained from patients in treatment than in control group, while significant low constipation was observed in treatment than in control group (35.0% vs 49.2%, P=0.026). Conclusion: Fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain, and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects, and improved quality of life.

• Journal of the Korean Society of Food Culture
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• v.30 no.2
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• pp.158-169
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• 2015

Tean Mado Shipwreck No. 3 is presumed to have been shipwrecked between 1260 and 1268. It departed from a Southern costal area of Yeosu in Jeonnam Province to Ganghwa Island, its final destination at which the temporal regime of Koryo Dynasty was located. In the shipwreck, a total of 35 wooden tablets were found, and forwarding places, senders, receivers, descriptions, and quantities of freight were written on the wooden tablets. The names of receivers included Kim Jun, who was influential in the late Musin Era of the Koryo Dynasty, and key institutions such as Junmin and Sambyulcho of the Musin force. Twenty wooden tables had lists of food items such as barley, abalone, salted-fermented abalone, mussel, dried mussel, salted fermented mussel, dried shark meat, fish oil, pheasant, and dried dog meat. The food items in the late 13th century were systematically examined using scientifically determined food organic remains and records of wooden tablets among the marine relics of Mado Shipwreck No. 3.

• Analytical Science and Technology
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• v.30 no.3
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• pp.154-158
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• 2017

The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

• Korean Journal of Plant Resources
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• v.21 no.1
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• pp.103-109
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• 2008

Nelumbo nucifera root(NNR) is used to clear summerheat(暑熱), bear Yang(陽) upwards and stop bleeding as mentioned in traditional Korean medicine. Also, it has been known that NNR is effective for lowering blood pressure and hyperlipidemia. The rhizome is considered to be nutritive, demulcent, diuretic and cholagogue and is used to treat piles, dyspepsia and diarrhea. An increasingly growing market for nutraceuticals and functional foods has triggered the study on natural sources for nutraceuticals, health foods and functional foods. But rhizome was inconvenient to formulate liquid dosage form(extract) by way of hot water because of its limited storage. Also the majority of the consumers have a complaint against the dosage. The purpose of this study was to develop the functional materials from NNR without side effects. We formulated the solid dosage form viz tablet and granule from the lotus root. Sensory evaluation was performed in terms of smell, taste, color and overall of lotus root and all colored forms(brown, dark brown, light green and yellow) of tablet and granule to evaluate the acceptability of the formulated tablets and granules. In sensory evaluation, among the formulated tablets and granules, light green granules obtained best score overall and yellow tablets showed the overall improved acceptability. In conclusion, lotus rhizome could be recommended as functional food. Further studies to clarify bioactive functions of Nelumbo nucifera in experimental animal model on atopic dermatitis are in progress.

• Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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• 2001.06a
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• pp.4113-4113
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• 2001

This study developed effective assay method of pharmaceutical quality control was developed by near-infrared spectroscopy (NIRS). The calibration equation model of assay was developed by 2nd deriviative PLS(Partial Least Squares) regression method with NIRS over the wavelength range from 1100 to 1400nm using diazepam tablets (2mg, 5mg). Although diazepam tablets are made by 5-different manufacture, they have similar formulation. When the correlation was compared with values by NIRS and HPLC, the R-2s and standard error of calibration (SEC) for 2mg were 0.9300 and 0.98%, the R-2s and SEC for 5mg were 0.9165 and 0.63%. The validation of the calibration equation model yield that the R-2s and standard error of prediction (SEP) for 2mg were 0.9611 and 0.995%, the R-2s and SEP for 5mg were 0.9114 and 0.842%. The method was validated on assay method for diazepam tablets by the calibration equation.