• YAKHAK HOEJI
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• v.36 no.3
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• pp.212-219
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• 1992

Although oral route is the most convenient route for drug administration, the short and variable transit of drug through GI tract restricts the sustained drug absorption after oral administration. Thus, for sustained absorption of drugs, it is desirable to prolong the GI transit time by retaining the dosage forms in the stomach. In this study, the enzyme-digestible swelling hydrogel was synthesized by heating the mixed solution of N-vinyl-2-pyrrolidone[monomer], acrylated albumin[crosslinking agent] and proxyphylline[drug] at $65^{\circ}C$ for 10 hours in the cylindrical test tube. The resultant hydrogel tablet (diameter; 0.77 cm, thickness; 0.47 cm) was designed to swell in the gastric fluid after oral administration to such a size that passing through the pylorus could be inhibited during the drug release. After releasing drug, the hydrogel was expected to be degraded by pepsin, an enzyme in the stomach, and eventually solubilized. Actually, the hydrogel synthesized in the study swelled to a size larger than the diameter of the pylorus ($1.3{\pm}0.7$ cm) and slowly digested in the presence of pepsin. Drug release from the hydrogel was prolonged up to about 12 hours. The swelling kinetics was dependent on albumin acrylation time, drug content and gel thickness. Particularly the gel thickness was the most important factor that influences on drug release. By adjusting these factors, the albumin-crosslinked hydrogel was expected to be retained in the stomach for up to 60 hours and used as a potential platform of drugs for long-term GI absorption.

• Korean Journal of Biological Psychiatry
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• v.3 no.2
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• pp.149-155
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• 1996

Doctors who treat pregnant women ore usually cautious in writing their prescription for the drugs. The problem of which psychotropic medications ore sale during pregnancy seems to remain unsolved for many years. Although the rate of absorption is reduced due to a reduced rate of gastric emptying, the extent of absorption of drug is generally unchanged during pregnancy. Plasma volume and total body water increase during pregnancy. There is suggestion that drug metabolizing activity may be increased in pregnancy. Since the pregnancy increase the glomerular filtration rate significantly, drugs mainly eliminated by renal excretion will be cleared more quickly. Factors contributing to the potential teratogenecity of a drug include the type of compound, dose and duration of use, developmental stage of fetus at the time of exposure, and the effect of the drug on fetal pharmacokinetics. All major classes of psychotropic agents should be assumed to diffuse readily across the placenta to the fetus and to be present in some quantity in the breast milk. To decide when and how to start the drug treatment depends on an assessment of the risks related both with and without drug treatment of psychiatric disorders.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.20 no.2
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• pp.128-137
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• 2010

This review summarizes gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions. Gender differences in pharmacokinetics are categorized by four major factors: absorption/bioavailability, distribution, metabolism, and elimination. There are sex-based differences in gastric emptying time, gastric alcohol dehydrogenase activity, apparent volume of distribution, ${\alpha}1$-acid glycoprotein level, phase I (CYP) and phase II metabolizing enzymes, glomerular filtration rate, and drug transporters. This review also reports gender differences in pharmacokinetics and pharmacodynamics of cardiovascular agents, central nervous system acting agents and antiviral agents. In addition, it has been reported that females experience more adverse reactions such as coughing, tachycardia, nausea, vomiting, rash, hypersensitivity, hepatotoxicity, and metabolic disorder after taking cardiovascular, central nervous system acting and antiviral agents. Therefore, in order to provide optimal drug dosage regimens both in male and female, gender differences in pharmacokinetics, pharmacodynamics, and adverse drug reactions must be considered.

• The Journal of Pediatrics of Korean Medicine
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• v.33 no.4
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• pp.1-25
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• 2019

Objectives The purpose of this study is to analyze the trends of Chinese clinical research in the last 5 years of Chinese herbal medicine treatment for anorexia in children, and to find ways to utilize the diagnostic criteria and herbal medicine treatment for children who have anorexia in Korea. Methods The authors searched literatures using China National Knowledge Infrastructure published from January 1, 2015 to June 18, 2019. Selected literatures were collected in order of recent publication year. And then, demographic data, duration of illness, intervention, treatment period, outcome, and adverse events were analyzed. In addition, the diagnostic criteria for anorexia in children are categorized and presented in chart. Results A total of 50 papers were included in the analysis of this study. In the selected studies, the most commonly used diagnostic criteria for anorexia in children were ${\ll}$Zhu Futang Practice of Pediatrics${\gg}$ in Western medicine and ${\ll}$Diagnostic and therapeutic criteria for TCM syndromes${\gg}$ in traditional Chinese medicine. As a result, in all the studies reporting total efficacy, the total effective rate of the treatment group treated with herbal medicine was significantly higher than that of the control group. Also, appetite recovery rate and weight gain were significantly higher, gastric emptying time and appetite recovery time were significantly shorter in the treatment group. Conclusions Herbal medicine treatment can help improve anorexia in children. In Korea, diagnostic criteria for anorexia in children should be established. In addition, criteria should be established to evaluate the effectiveness of herbal medicine treatment.

• YAKHAK HOEJI
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• v.37 no.5
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• pp.511-519
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• 1993

The short and variabke transit of drug throught GI tracj and the inter-and intra-subject variations of the transit restrict the sustained drug absorption after oral adminstration. These restrictions may be solved by retaining the dosage forms in the stomach. Then the dosage form will act as a platform which releases the drug slowly and makes the GI absorption occur for a long time. In this study, as the platforms, PVP hydrogels were synthesized by chemical and y-irradiation method in the cylindrical test tube. The chemical method means the synthesis of the hydrogel by heating the mixed solution of N-vinyl-2-pyrrolidone [monomer], acrylated albumin [crosslinking agent], 2, 2'-agobis(2-methylpropionitrile) [initiator] and proxyphylline [drug] at $65^{\circ}C$ for 5 hr. The $\gamma$-irradiation method means the synthesis of the hydrogel by irradiation with $^{60}$ Co $\gamma$-ray of the mixed solution of the monomer, acrylated albumin, and flurbiprofen [drug] at room temperature with total 0.2 Mrad for 3 hr. Our intention is to design the hydrogel tablet (diameter : 1.20 cm, thickness : 0.60 cm) which swells in the gastric fluid after oral administration to such a size that passing through the pylorus could be inhibited during the period of drug release. After releasing drug, the hydrogel should be degraded by the enzymeatic digestion in the stomach, or by hydrolysis and eventually solubilized. Thus, in votro tests were performed to examine the factors that affect swelling and drug release from the PVP hydrogels. Experimental results show that the hydrogels swell to a size larger than the diameter of the pylorus(l.3$\pm$0.7 cm) and the hydrogel prepared by the chemical method is digested by pepsin. But the hydrogel prepared by the $\gamma$-irradiation method was not digested by the pepsin and just collapsed with time. Thus, the swelling of the hydrogel synthesized by $\gamma$-irradiation was independent albumin acrylation time and pepsin concentration. But drug content and radiation dose affected the swelling and drug release kinetics of the hydrogel. Drug release from the hydrigels was prolonged up to about 24 hr. Therefore, it was concluded that by adjusting these factors, the albumin-crosslinked PVP hydrogel synthesized by $\gamma$-irradiation method is expected to be retained in the stomach for up to 60hr and be a potential platform of drugs for long-term GI absorption.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.82-88
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• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• YAKHAK HOEJI
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• v.50 no.6
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• pp.386-392
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• 2006

Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.

• Journal of Haehwa Medicine
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• v.18 no.1
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• pp.19-28
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• 2009

Objectives: This study was conducted to help clinical studies for treating Functional Dyspepsia with acupuncture. We inspected tendency of studies of acupuncture treatment for functional dyspepsia and analyzed the assessing instrument for it by scrutinizing Pubmed recent publications. Materials and Methods: We inspected 8 theses and scrutinized their objectives, periods, participants, materials and methods, the instrument of assessment for the studies, and criteria and symptom score for questionaire, results and JADAD score. Results: 1. Most studies were published by oriental doctors except one which was published by an American doctor. More and more studies are being published in America and written in English recently. So it is considered that western doctors think that the acupuncture treatment is useful as unorthodox medicine for functional dyspepsia. 2. Among the 4 clinical studies, 2 studies were RCT and 1 study was not RCT and 1 study with vagueness. All 4 clinical studies were not double-blinded because they were about comparison between acupuncture treatment and medicine. 3. ST36, PC6, CV12, BL21 were chiefly used, and auricular point, ST40, SP6 were also used. Manual acupuncture were used in 2 studies, and low frequency pulse and electroacupuncture were used in other studies respectively. 4. 4 clinical studies used 0~3 points symptom score as the instrument of assessment. Additional assessments were on gastric emptying time, EGG and plasma level of motilin. All thesis were not verified of validity and reliability. 5. Among the 4 reviewed thesis, 2 theses were about acupuncture as one of the various treatment of functional dyspepsia, and the other 2 theses were about efficacy of acupuncture treatment. And the result generally showed effectivity of acupuncture treatment. Conclusion: Acupuncture treatment for functional dyspepsia is considered useful as in unorthodox medicine by western doctors, and it is necessary to provide objective instrument for assessing acupuncture treatment for functional dyspepsia.