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首页> 外文期刊>Journal of the American Pharmacists Association: JAPhA >Omeprazole absorption from a compounded transdermal formulation in healthy volunteers.
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Omeprazole absorption from a compounded transdermal formulation in healthy volunteers.

机译：奥美拉唑在健康志愿者中从复合透皮制剂中吸收。

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OBJECTIVE: To evaluate the plasma concentration versus time profile of omeprazole following the administration of a compounded transdermal gel formulation in healthy volunteers. DESIGN: Single-dose transdermal pharmacokinetic (PK) study including a comparison with historical data from an oral PK study. SETTING: Academic clinical research center. PARTICIPANTS: Eight healthy volunteers between 18 and 50 years of age. INTERVENTIONS: Omeprazole gel 40 mg (0.8 mL) was applied to the ventral surface of the forearm covering an area of 7 x 15 cm without an occlusive dressing. Blood samples were collected just before application and then at 1, 2, 3, 4, 6, and 8 hours. Plasma concentrations of omeprazole were determined using a validated liquid chromatography tandem mass spectrometry method. MAIN OUTCOME MEASURES: PK parameters (maximal plasma concentration [C(max)], the time of C(max), [T(max)], the area under the omeprazole concentration versus time curve from 0 to 8 hours, the elimination rate constant, and the half-life of the elimination phase) following transdermal administration, compared with historical controls who had received an oral omeprazole 40 mg dose during a previous study. RESULTS: Of the eight volunteers, five had undetectable plasma omeprazole concentrations throughout the 8-hour study, precluding a complete PK analysis. For the three volunteers with detectable plasma omeprazole concentrations, the values ranged from 0.204 to 0.552 ng/mL. Including values of 0 for the patients with undetectable levels, the mean (+/- SD) C(max) was 0.153 +/- 0.241 ng/mL, and the T(max) in patients with detectable levels occurred at approximately 6 hours. The plasma concentrations following transdermal administration were approximately 1,000-fold lower than those observed with oral dosing. CONCLUSION: Transdermal absorption from a single dose of the omeprazole gel formulation used in this study was poor. This transdermal gel formulation is clearly not bioequivalent to the oral capsule.
机译：目的：评估在健康志愿者中服用复合透皮凝胶制剂后奥美拉唑的血药浓度与时间的关系。设计：单剂量透皮药代动力学（PK）研究，包括与口服PK研究的历史数据进行比较。单位：学术临床研究中心。参与者：8位18至50岁的健康志愿者。干预措施：将40毫克奥美拉唑凝胶（0.8毫升）涂在前臂的腹侧表面，覆盖面积7 x 15厘米，而无闭塞敷料。在应用之前，然后在1、2、3、4、6和8小时收集血液样本。奥美拉唑的血浆浓度使用经过验证的液相色谱串联质谱法测定。主要观察指标：PK参数（最大血浆浓度[C（max）]，C（max）的时间，[T（max）]，奥美拉唑浓度下的面积与时间的关系曲线（从0到8小时），消除率与在先前研究中接受口服奥美拉唑40 mg剂量的历史对照相比，经皮给药后的平均水平和清除期的半衰期）。结果：在八名志愿者中，有五名在整个8小时研究中均检测不到血浆奥美拉唑浓度，这排除了完整的PK分析。对于血浆奥美拉唑浓度可检测的三名志愿者，其值的范围为0.204至0.552 ng / mL。包括未检测到水平的患者的0值，平均（+/- SD）C（max）为0.153 +/- 0.241 ng / mL，可检测到水平的患者的T（max）发生在大约6小时。透皮给药后的血浆浓度比口服给药时观察到的血浆浓度低约1,000倍。结论：本研究使用的单剂量奥美拉唑凝胶制剂的透皮吸收差。这种透皮凝胶制剂显然与口服胶囊没有生物等效性。

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