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PREDICTIVE PHARMACOKINETICS OF TRAMADOL HYDROCHLORIDE FLOATING TABLETS

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单位: [1]China Japan Friendship Hosp, Beijing 100029, Peoples R China [2]Beijing Hosp Tradit Chinese Med, Shunyi Branch, Beijing 101300, Peoples R China [3]Beijing Univ Chinese Med, Beijing 100029, Peoples R China [4]Capital Med Univ, Beijing Friendship Hosp, Beijing 100050, Peoples R China [5]Beijng Pinggu Hosp Tradit Chinese Med, Beijing 101200, Peoples R China [6]Beijing Univ Chinese Med, Dongzhimen Hosp, Beijing 100700, Peoples R China
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关键词: dissolution convolution pharmacokinetics tramadol

摘要:
The purpose of this study was to propose the effectiveness of convolution approach to predict pharmacokinetics of tramadol hydrochloride floating tablets, prepared by using various ratios of carbopol, HPMC K100M, and Hibiscus rosa Sinensis as excipient. The in vitro dissolution test was conducted using paddle method in 900 mL of HCl buffer with pH 1.2 to simulate the gastric condition. The stirring speed of paddles was set at 70 rpm. Temperature of dissolution medium was adjusted at 37 +/- 5 degrees C. At predetermined time points, 5 mL of dissolution samples were taken with a replacement of same volume using fresh medium. The obtained samples were analyzed at 271 nm using UV visible spectrophotometer. The values of predicted pharmacokinetic parameters like C-max (maximum blood drug level), T-max (time required to attain maximum blood drug level), and AUC (area under blood drug concentration curve) ranged between 80.8 +/- 3.2-119.6 +/- 4.7 ng/mL, 11.4 +/- 0.2-12.2 +/- 0.2 h, and 1430.5 +/- 209.5-1970.6 +/- 287.4 ng.h/mL, respectively. This certainly is a desired feature required at the formulation development step, where the formulator requires the development of a formulation using desired in vivo features on the basis of only accessible in vitro data. It can be concluded from the results that convolution method is a practical method for the prediction of drug concentration in blood and for quality control.

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出版当年[2015]版:
大类 | 4 区 医学
小类 | 4 区 药学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 药学
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出版当年[2014]版:
Q4 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q4 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2014版] 出版当年五年平均[2010-2014] 出版前一年[2013版] 出版后一年[2015版]

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第一作者单位: [1]China Japan Friendship Hosp, Beijing 100029, Peoples R China
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