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한국약제학회> 약제학회지

약제학회지

Journal of Pharmaceutical Investigation

  • : 한국약제학회
  • : 의약학분야  >  약품제제
  • : KCI등재
  • : SCOPUS
  • : 연속간행물
  • : 격월
  • : 2093-5552
  • :
  • : Journal of Korean Pharmaceutical Sciences(~2010)→약제학회지(2010~)

수록정보
수록범위 : 1권1호(1971)~41권5호(2011) |수록논문 수 : 1,610
약제학회지
41권5호(2011년 10월) 수록논문
최근 권호 논문
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KCI등재 SCOPUS

1Review : Multi-Layered Matrix Tablets with Various Tablet Designs and Release Profiles

저자 : ( Du Hyung Choi ) , ( Seong Hoon Jeong )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 263-272 (10 pages)

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Tablet dosage forms have been preferred over other formulations for the oral drug administration due to their low manufacturing costs and ease of administrations, especially controlled-release applications. Controlled-release tablets are oral dosage forms from which the active pharmaceutical ingredient (API) is released over an intended or extended period of time upon ingestion. This may allow a decrease in the dosing frequency and a reduction in peak plasma concentrations and hence improves patient compliance while reducing the risk of undesirable side effects. Conventional single-layered matrix tablets have been extensively utilized to deliver APIs into the body. However, these conventional single-layered matrix tablets present suboptimal delivery properties, such as non-linear drug delivery profiles which may cause higher side effects. Recently, a multi-layered technology has been developed to overcome or eliminate the limitations of the single-layered tablet with more flexibility. This technology can give a good opportunity in formulating new products and help pharmaceutical companies enhancing their life cycle management. In this review, a brief overview on the multi-layered tablets is given focusing on the various tablet designs, manufacturing issues and drug release profiles.

KCI등재 SCOPUS

2Original Articles : Pharmacokinetic Interaction between Warfarin and Efonidipine in Rats

저자 : ( Dong Hyun Choi ) , ( Jun Shik Choi )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 273-278 (6 pages)

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The aim of this study was to investigate the effect of efonidipine on the pharmacokinetics of warfarin after oral and intravenous administration of warfarin in rats. Warfarin was administered orally (0.2 mg/kg) or intravenously (0.05 mg/kg) without or with oral administration of efonidipine (1 or 3 mg/kg) in rats. The effect of efonidipine on the cytochrome P450 (CYP) 3A4 activity was also evaluated. Efonidipine inhibited CYP3A4 enzyme activity with 50% inhibition concentration (IC50) of 0.08 μM. Compared to those in the oral control group (warfarin without efonidipine), the area under the plasma concentration-time curve (AUC) of warfarin was significantly greater (1 mg/kg, P<0.05; 3 mg/kg, P<0.01) by 25.9-59.0%, and the peak plasma concentration (Cmax) was significantly higher (3 mg/kg, P<0.05) by 26.2% after oral administration of warfarin with efonidipine, respectively. The total body clearance of warfarin was significantly (3 mg/kg, P<0.05) decreased by efonidifine. Consequently, the relative bioavailability of warfarin was increased by 1.26- to 1.59-fold and the absolute bioavailability of warfarin with efonidipine was significantly greater by 59.7-75.4 % compared to that in the control group (47.4%). In contrast, efonidipine had no effect on any pharmacokinetic parameters of warfarin given intravenously. Therefore, the enhanced oral bioavailability of warfarin may be due to inhibition of CYP 3A4-mediated metabolism in the intestine and/or liver and to reduction of total body celarance rather than renal elimination, resulting in reducing first-pass metabolism by efonidipine.

KCI등재 SCOPUS

3Original Articles : Dexamethasone Release from Glutaraldehyde Cross-Linked Chitosan Microspheres: In Vitro/In Vivo Studies and Non-Clinical Parameters Response in Rat Arthritic Model

저자 : ( Magharla Dasaratha Dhanaraju ) , ( Sheela Elizabeth ) , ( Ganesan Poovi )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 279-288 (10 pages)

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The Dexamethasone (DEX) loaded chitosan microspheres were prepared by thermal denaturation and chemical cross-linking method using a dierent concentration of glutaraldehyde as chemical cross-linking agent. The prepared microspheres were evaluated for the percentage of Drug Loading (DL), Encapsulation Efficiency (EE) and surface morphology by Scanning Electron Microscopy (SEM). DL and EE were found to be maximum range of 10.0 to 10.79 % and 58.19 to 64.73 % respectively. The SEM Photographs of the resultant microspheres exhibited fairly smooth surfaces and predominantly spherical in appearance. In addition, Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) shown that there was no interaction between the drug and polymer. In vitro and in vivo release studies revealed that the release of dexamethasone was sustained and extended up to 63 days and effectively controlled by the extent of cross-linking agent. Non-clinical parameters such as paw volume, hematological parameters like Erythrocyte Sedimentation Rate (ESR), Paced Cell Volume (PCV), Total Leucocytes Count (TLC), Hemoglobin (Hb), Differential Cell Count (DCC) were investigated in Fruend``s Complete Adjuvant (FCA) induced arthritic rats. Radiology and histopathological studies were also performed in order to evaluate the therapeutic efficacy of the DEX-loaded microspheres in extenuating the rat arthritic model.

KCI등재 SCOPUS

4Original Articles : Pharmacokinetic Analysis of Montelukast in Healthy Korean Volunteers by High Performance Liquid Chromatography-Tandem Mass Spectrometry

저자 : ( Min Ho Jo ) , ( Mi Sun Park ) , ( Ji Hyung Seo ) , ( Wang Seob Shim ) , ( Sung

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 289-294 (6 pages)

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A rapid and specific high performance liquid chromatography-tandem mass (LC/MS/MS) method for the analysis of montelukast in human plasma has been developed and validated. After cold acetonitrile-induced precipitation of the plasma samples, montelukast and glipizide (internal standard, IS) were eluted on a reverse-phase C18 column by isocratic mobile phase consisted of 10 mM ammonium formate buffer (adjusted to pH 3.5 with formic acid) and acetonitrile (3:97, v/v). Acquisition was performed with multiple reaction monitoring (MRM) mode by monitoring the transitions: m/z 587.2→ 423.2 for montelukast and m/z 446.0→321.2 for IS. Ranges of concentration for calibration curves (10-1000 ng/mL) showed correlation coefficients (r2) were better than 0.9948. Precision of intra- and inter-day ranged from 3.70 to 11.68% and from 3.04 to 12.95%, accuracy of intra-day and inter-day ranged from 93.34 to 102.75% and from 100.79 to 107.63%, respectively. The described method provides a fast and sensitive analytical tool for determining montelukast levels in plasma, and was successfully applied to a pharmacokinetic study in 16 healthy human subjects after oral administration of 10mg tablet formulation of montelukast sodium under fasting conditions.

KCI등재 SCOPUS

5Original Articles : Preparation and Characterization of Tributyrin Sub-micron Emulsion as Carrier for Paclitaxel

저자 : ( Xiang Fei ) , ( Wen Ting Xu ) , ( Yuan Yue ) , ( Mi Kyung Lee )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 295-300 (6 pages)

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Paclitaxel is a well known anticancer agent and has been a pharmaceutical challenge because of its extremely poor water-solubility and susceptibility to the p-glycoprotein (p-gp)-mediated efflux in multi-drug resistant (MDR) cancer cells. Tributyrin (TB), a triglyceride with relatively short fatty acid chains, was chosen as solubilizing vehicle for paclitaxel based on the solubility study (26.6 mg/mL). Tributyrin (10%) o/w emulsion containing paclitaxel (5%), egg phosphatidylcholine (5%) and pegylated phospholipid (0.5%) was prepared by high pressure homogenization to obtain submicron- sized emulsion. The mean particle size of the resultant TB emulsion was 395.5 nm. Paclitaxel in TB emulsion showed higher anticancer activity against human breast cancer cell line, MCF-7, than free form delivered in DMSO solution. On the other hand, its anticancer activity was significantly reduced in MCF-7/ADR, a MDR variant cancer cell line of MCF- 7, and recovered by the presence of verapamil, suggesting of the susceptibility to the p-gp mediated efflux even though paclitaxel was encapsulated into emulsion. The TB emulsion showed great potential as a promising vehicle for water-insoluble anticancer agent, paclitaxel.

KCI등재 SCOPUS

6Original Articles : Effects of Kaempferol, an Antioxidant, on the Bioavailability and Pharmacokinetics of Nimodipine in Rats

저자 : ( Ji Won Park ) , ( Jin Seok Choi ) , ( Jun Shik Choi )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 301-307 (7 pages)

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The aim of this study was to investigate the effects of kaempferol on the pharmacokinetics of nimodipine in rats. Nimodipine and kaempferol interact with cytochrome P450 (CYP) enzymes and P-glycoprotein (P-gp), and the increase in the use of health supplements may result in kaempferol being taken concomitantly with nimodipine as a combination therapy to treat orprevent cardiovascular disease. The effect of kaempferol on P-gp and CYP3A4 activity was evaluated and Pharmacokinetic parameters of nimodipine were determined in rats after an oral (12 mg/kg) and intravenous (3 mg/kg) administration of nimodipine to rats in the presence and absence of kaempferol (0.5, 2.5, and 10 mg/kg). Kaempferol inhibited CYP3A4 enzyme activity in a concentration-dependent manner with 50% inhibition concentration (IC50) of 17.1 μM. In addition, kaempferol significantly enhanced the cellular accumulation of rhodamine-123 in MCF-7/ ADR cells overexpressing P-gp. Compared to the oral control group, the area under the plasma concentration-time curve (AUC0-∞) and the peak plasma concentration (Cmax) of nimodipine significantly increased, respectively. Consequently, the absolute bioavailability of nimodipine in the presence of kaempferol (2.5 and 10 mg/kg) was 29.1-33.3%, which was significantly enhanced compared to the oral control group (22.3%). Moreover, the relative bioavailability of nimodipine was 1.30- to 1.49-fold greater than that of the control group. The pharmacokinetics of intravenous nimodipine was not affected by kaempferol in contrast to those of oral nimodipine. Kaempferol significantly enhanced the oral bioavailability of nimodipine, which might be mainly due to inhibition of the CYP3A4-mediated metabolism of nimodipine in the small intestine and /or in the liver and to inhibition of the P-gp efflux transporter in the small intestine by kaempferol. The increase in oral bioavailability of nimodipine in the presence of kaempferol should be taken into consideration of potential drug interactions between nimodipine and kaempferol.

KCI등재 SCOPUS

7Note : Bioequivalence Assessment of Acephyll(R) Capsule to Surfolase(R) Capsule (Acebrophylline HCl 100 mg) by Liquid Chromatography Tandem Mass Spectrometry

저자 : ( Kyung Don Nam ) , ( Ji Hyung Seo ) , ( Sung Vin Yim ) , ( Kyung Tae Lee )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 309-315 (7 pages)

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A sensitive and specific liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/ MS) was developed for the analysis of ambroxol (active moiety of acebrophylline). After acetonitrile precipitation of proteins from plasma samples, ambroxol and the domperidone (internal standard, IS) were eluted on a C18 column. The isocratic mobile phase was consisted of 10 mM ammonium acetate and methanol (10 : 90, v/v), with flow rate at 0.2 mL/min. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z 379.2→264.0 and the m/z 426.2→175.1 transitions for ambroxol and the IS, respectively. Twenty four healthy Korean male subjects received two capsules (100 mg × 2) of either the test or the reference formulation of acebrophylline HCl in a 2 × 2 crossover study, this was followed by a 1week washout period between either formulation. AUC0-t (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 (e.g., log 0.8964 - log 0.9910 for AUC0-t log 0.8690 - log 1.0750 for Cmax). The major parameters, AUC0-t and Cmax met the criteria of Korea Food and Drug Administration for bioequivalence indicating that Acephyll(R) capsule (test) is bioequivalent to Surfolase(R) capsule (reference).

KCI등재 SCOPUS

8Note : Bioequivalence of Traline Tablet to Zoloft(R) Tablet (Sertraline HCI 50 mg)

저자 : ( Hyun Ah Kang ) , ( Hea Young Cho ) , ( Yong Bok Lee )

발행기관 : 한국약제학회 간행물 : 약제학회지 41권 5호 발행 연도 : 2011 페이지 : pp. 317-322 (6 pages)

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Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessive-compulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft(R) tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, 23.50± 1.74 years in age and 64.09±7.10 kg in body weight, were divided into two groups and a randomized 2 × 2 crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and un-transformed Tmax. The results showed that the differences between two formulations based on the reference drug, Zoloft(R) tablet, were 0.04, 3.26 and -1.29% for AUCt, Cmax, and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft(R) tablet.

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