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생체시료 중 실로스타졸의 분석조건 설정 및 실로스타졸 제제의 생물학적동등성
신택환,우혜승,전현주,박혜숙,최영욱 중앙대학교 약학연구소 2001 약학 논총 Vol.15 No.-
Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platelet cyclic AMP phosphodiesterase. A fast short-step and simple method for determining of cilostazol in human plasms has been developed and validated. The procedure was linear in the range from 0.05 to 2ug/ml for cilostazol. The intraday and interday validation for coefficient of variance (CV, %) and relative error (RE) were less than ±15%. Based on this analysis method, the bioequivalence of two cilostazol tablets, Pletaal^TM and Stazol^TM was evaluated according to the guidlines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 64.6±5.9kg in body weight and 23.2±1.5 yr in age, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 50mg of cilostazol were orally administered, blood samples were taken at the predetermined time intervals. The concentrations of cilostazol in plasma were determined by liquid-liquid extraction method using HPLC with UV detector. Pharmacokinetic parameters such as AUC, C_max and T_max were calculated and ANOVA was employed for the statistical analysis of the parameters. The results were revealed that the differences in AUC, C_max and T_max between two tablets were 7.903%, 1.100% and 10.654%, respectively. The power (1-β) for AUC and C_max were above than 80%. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8, and 90% confidence intervals for AUC and C_max were all less than ±20. All of the above mentioned parameters met the criteria of KFDA guidlines for bioequivalence, indicating that Stazol^TM tablet is bioequivalent to Pletaal^TM tablet.
친수성 폴리머 제피를 이용한 말레인산암로디핀 정제의 안정성 개선
최인식,신택환,최성업,이재휘,최영욱 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
New formulations of amlodipine maleate tablet have been investigated to enhance the stability of the drug against light and humidity. Three kinds of amlodipine maleate tablets were prepared. One is prepared by previously known formulation (formulation C), the others were by new formulations using hydrophilic polymer (Opadry?) coated granules (formulations A and B). Amlodipine maleate powder was coated with Opadry? to produce the coated granules and it was mixed with other excipients to produce the tabletting mass of new formulations A and B. Dissolution rate of newly formulated tablets was over 80% within 10 minutes in 0.01 M HC1 medium, and its dissolution pattern was similar to that of Norvasc? tablet. After 6 months storage under accelerated conditions, residual drug contents of tested formulations (A and B) were not significantly different from formulation C, ranging from 96.2 to 100.4%. Meanwhile, dissolution amount of formulation C was significantly reduced compared to that of formulation A (p<0.05), showing formulation A was more stable than unprotected formulation C at the accelerated conditions. Results of appearance, hardness and disintegration remained unchanged during stability study. In conclusion, it showed that the new formulations had enhanced the stability characteristics and hydrophilic coating technique was an alternative and promising method to improve the stability of amlodipine maleate tablet.
혈장 중 트리플루살의 분석조건설정 및 트리플루살 제제의 생물학적 동등성
우혜승,신택환,전호성,최성업,이상길,조성완,최영욱 중앙대학교 약학연구소 2000 약학 논총 Vol.14 No.-
Triflusal is an inhibitor of platelet aggregation structurally related to the salicylate group. Triflusal and its active metabolite 2-hydroxy-4-trifluoromethyl benzoic acid (HTB) have platelet antiaggregant effect. A fast short-step and simple method for determining of triflusal in human plasma has been developed and validated. The procedure was linear in the range from 0.1 to 5 ug/ml for triflusal. The intraday and interday validation for coefficient of variance (CV, %) and relative error (RE) were less than ±15%. Based on this analysis method, the bioequivalence of two triflusal capsules, Disgren^TM and Tris^TM was evaluated according to the guidlines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 66.25±6.82kg in body weight and 23.25±1.48 in age, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 300mg of triflusal was orally administered, blood samples were taken at the predetermined time intervals and the concentrations of triflusal in plasma were determined by protein precipitation method using HPLC with UV detector. Pharmacokinetic parameters such as AUC, C_max and T_max were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in AUC, C_max and T_max between two capsules were 2.58%, -0.74% and 17.09%, respectively. The power (1-β) for AUC and C_max were above than 80%. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 and 90% confidence intervals for AUC and C_max were all less than ±20. All of the above mentioned parameters met the criteria of KFDA guidlines for bioequivalence, indicating that Tris^TM capsule is bioequivalent to Disgren^TM capsules.