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정재희,최한곤,박선주,유제만,윤성준 ( Jae Hee Jung,Han Gon Choi,Sun Joo Park,Jei Man Ryu,Sung June Yoon ) 한국약제학회 1997 Journal of Pharmaceutical Investigation Vol.27 No.2
N/A 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, magnesiun 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) (㎎/tablet)] are potential candidate for buccal drug delivery system.
아세트아미노펜 액상좌제의 물리화학적 특성에 미치는 첨가제의 영향
최한곤(Han Gon Choi),정재희(Jae Hee Jung),유제만(Jei Man Ryu),이미경(Mi Kyung Lee),김인숙(In Sook Kim),이범진(Beom Jin Lee),김종국(Chong Kook Kim) 대한약학회 1998 약학회지 Vol.42 No.3
To optimize the formulation of acetaminophen liquid suppository, the effect of additives on the physicochemical properties of liquid suppository base was investigated. The physicochemical properties of P 407/P 188 (15/15%) (abbreviated in 15/15) and P 407/P l88 (15/20%) (abbreviated in 15/20) were measured after the addition of following additives; 2.5% acetaminophen as an active ingredient, vehicle components (5% ethanol, 5% propylene glycol, 5% glycerin), preservatives (0.1% sodium benzoate, 0,1% methylparahydroxybenzoate, 0.1% propylparahydroxybenzoate) and 1% of sodium chloride as an ionic strength controlling agent. Poloxamer gel was prepared with three different buffer solutions (pH 1.2, 4.0 and 6.8) and the physicochemical properties, gelation temperature, gel strength and bioadhesive force, were determined. In the results, the effect of additives on the physicochemical properties was dependent on their bonding capacities including hydrogen bonding and cross-linking bonding. Because the hydrogen-bonding capacities of acetaminophen, ethanol and propylene glycol were smaller than that of poloxamer, the binding force of poloxamer gel became weak by their putting in between poloxamer gel. Therefore, the gelation temperature (15/15, 35.7oC vs 37.0, 39.4 38.2oC; 15/20, 29.2oC vs 31.2, 32.0, 30.3 oC) increased, and gel strength (15/15, 4.03 see vs 2.72, 2.08, 3.12sec; 15/20, 300g vs 50, 50, 200g) and bioadhesive force (15/15, 6.8 X 102 dyne/cm2 vs 3.2, 6.0, 6.0 X 102 dyne/cm2; 15/20, 97.3 X 102 dyne/cm vs 11.1, 89.5, 92.0 X 102 dyne/cm2) decreased. Furthermore, the binding force of poloxamer gel became strong due to the hydrogen-bonding capacities of glycerin and the cross-liking bonding of sodium salt. Then, the gelation temperature (15/15, 35.0, 32.1oC; 15/20, 26.0, 21.0oC) decreased, and gel strength (15/15, 6.51 see, 300g; 15/20, 500, 650g) and bioadhesive force (15/15, 7.2, 81.6 X 102 dyne/cm2; 15/20, 112.3, 309.2 X 102 dyne/cm2) increased. The effect of pH on the physicochemical properties of poloxamer gel was dependent on the ingredients with which the buffer solutions were prepared. Poloxamer gels prepared with pH 1.2 and 4.0 buffer solutions had the increasing gelation temperature (15/15, 37.5, 38.1oC; 15/20, 33.1, 34.0oC) and the decreasing gel strength (15/15, 2.98, 3.81sec; 15/20, 200, 200g) and bioadhesive force (15/15, 7.0 X 102dyne/cm2; 15/20, 74.0-88.1 X 102dyne/cm2) owing to HCl. Poloxamer gel prepared with pH 6.8 buffer solutions had the decreasing gelation temperature (15/15, 27.2oC; 15/20, 22.3oC) and the increasing gel strength (15/15, 400g; 15/20, 550g) and bioadhesive force (15/15, 207.0 X 102dyne/cm2; 15/20, 215.0 X 102dyne/cm2) due to the cross-linking bonding of NaH2PO4 and K2HPO4.
문은이(Eun Yi Moon),이진(Jin Lee),이원용(Won Yong Lee),최청하(Chung Ha Choi),이덕근(Dug Keun Lee),유제만(Jei Man Ryu),정용호(Yong Ho Chung),윤성준(Sung June Yoon),박경배(Kyung Bae Park) 한국응용약물학회 1997 Biomolecules & Therapeutics(구 응용약물학회지) Vol.5 No.3
DW-166HC (^(166)Holmium (^(166)Ho)-Chitosan complex) is a new radiopharmaceutic anticancer agent with a broad anti-tumorigenic spectrum, especially against human hepatic cancer. DW-166HC was evaluated for the appearance of micronucleus in polychromatic erythrocytes (PCEs) of mouse bone marrow cells after subcutaneous arid intravenous single administration. Bone marrow cells were prepared at 24 hr and 48 hr after DW-166HC-I (^(165)Ho-Chitosan complex : cold compound) administration and at 24 hr, 72 hr and 2 weeks after DW-166HC (^(166)Ho-Chitosan complex : hot compound) administration. The results showed there was no statistically significant increase of the numbers of PCEs with micronucleus in all DW-166HC-I administered groups compared with a negative control group but there was statistically significant increase of the numbers of PCEs with micronucleus at 24 hr arid 72 hr in all DW-166HC administered groups, which was recovered after 2 weeks from the drug administration. The results also showed the ratio of normochromatic erythrocytes (NCEs) to PCEs of all DW-166HC-I administered groups was not significantly different from that of a negative controi group but there was significant difference of this ratio at 24hr and 72 hr in all DW-166HC administered groups compared with that of negative group, which was also recovered after two weeks from the drug administration. These results suggested that DW-166HC-I may not cause any chromosomal damage but DW-166HC has in vivo mutagenic potential because of its radioactivity.
윤광희(Kwang Hee Yun),박진영(Jin Young Park),박선주(Sun Joo Park),조은희(Eun Hee Cho),유제만(Jei Man Ryu),김경식(Kyung Sik Kim),정석재(Suk Jae Chung),이민화(Min Hwa Lee),심창구(Chang Koo Shim) 한국응용약물학회 1999 Biomolecules & Therapeutics(구 응용약물학회지) Vol.7 No.1
A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2 x 2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentrationtime curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. C_(max)(maximum plasma drug concentration) and T_(max)(time to reach C_(max)) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, C_(max) and T_(max) between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, C_(max) and T_(max), respectively). Minimum detectable differences(%) at α=0.05 and 1-β=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, C_(max) and T_(max) respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9∼16.4, -13.2∼0.1 and -7.8∼11.4% for AUC, C_(max) and T_(max) respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.
문은이(Eun Yi Moon),최청하(Chung Ha Choi),성승규(Seung Kyoo Seong),이진(Jin Lee),유제만(Jei Man Ryu),이문선(Moon Sun Lee),정상헌(Sang Hun Jung),정용호(Yong Ho Chung),이덕근(Dug Keun Lee),윤성준(Sung June Yoon) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.4
DW2282, (S)-(+)-4-phenyl-1-[N-(4-aminobenzoyl)-indolin-5-sulfonyl]-4,5-dihydro-2-imidazolone hydrochloride, is a novel anticancer agent thought to have an unique mechanism of action on the inhibition of tumor growth. In this study, we estimated in vivo antitumor activities and pharmacokinetics of DW2282 depending on various vehicles. The inhibition rate of tumor growth was increased by 50, 100 and 200 mg/kg of DW2282 in a dose-dependent manner. When DW2282 dissolved in 4 sorts of vehicles was orally single dosed to rats at 50 mg/kg, Cmax of DW2282 in 0.5% CMC.Na was a half as high as those in PG, PG+CP and PG+CP+DW. When DW2282 was orally administered to mice for 5 days, antitumor activity of 130 mg/kg suspended in 0.5% CMC.Na was as effective as that of 65 mg/kg dissolved in the rest of vehicles. Taken together, it is thought that antitumor activities of DW2282 are resulted from the absorption extent of it and related to the vehicle used.
테르페나딘-β-시클로덱스트린 포접화합물의 제조방법 및 물리화학적 특성
최한곤,유제만,윤성준 한국약제학회 1997 Journal of Pharmaceutical Investigation Vol.27 No.3
Terfenadine, antihistaminic drug, is poorly soluble in water. The purpose of this study is to investigate the possibility of using terfenadine-β-cyclodextrin inclusion compound, instead of terfenadine, as the active substance of solid dosage form by improving the solubility, dissolution and anti-histaminic activity of terfenadine. The solubility and binding characteristics of terfenadine-β-cyclodextrin complex in pH 1.2∼6.8 were investigated. Furthermore, the preparing method of terfenadine-β-cyclodextrin inclusion compound was setting up and its physico-chemical characteristics such as DSC curve, solubility, dissolution and anti-histaminic activity were investigated. In conclusion, the solubility of terfenadine was increasing by β-cyclodextrin and with the decreasing pH. Terfenadine-β-cyclodextrin inclusion compound, whose yield is almost 100%, was prepared by neutralization method. This inclusion compound was 200-times as soluble as terfenadine in pH 1.2-6.8. In addition, it had the faster dissolution and anti-histaminic activity than terfenadine. Therefore. it is used to the active substance of solid dosage form such as tablet and capsule in stead of terfenadine.