背景获专利的 remote controlled 囊(RCC ) 最近被开发了在允许对的评价的人的内脏提供 noninvasive 药交货给选择地点地区性胃肠(官方补给) 在正常生理的环境下面的药吸收。这研究的目的是用 RCC 和监视的一个磁性的标记( MMM )在官方补给的道在这药的地点特定的交货以后调查 aminophylline 吸收的率和程度 technique.Methods 这研究在 12 个健康男题目被进行,在里面一三处理,使随机化,有7天的冲刷的转线路举止。合格题目通过一个口头的政府收到了 150 mg aminophylline 剂量,或经由 remote controlled 囊,送到小肠或上升冒号。MMM 被采用监视 RCC 的官方补给的运输,并且无线电频率信号被用来在目标地点激活囊。血样品在常规间隔被获得直到 24 小时柱子剂量 / 激活。血浆 theophylline 集中被一个 TDx 系统分析器测量。有 aminophylline 的口头的 dosing 线路的 PK 侧面的比较在交货以后被执行到小肠和 colon.Results RCC 很好在志愿者被容忍。小肠和上升冒号的吝啬的囊激活时间是 2.07 个小时和 6.08 小时柱子剂量。 Aminophylline 与胃相比从小肠有类似的吸收侧面,与在曲线( AUC_t )下面的一个区域92%的比率对胃,而是从上升冒号的更低的吸收侧面,与47.2%的 AUC_t 比率对 stomach.Conclusions RCC 和 MMM 技术提议的业主在 noninvasive 下面在人在药的肠的吸收上获得数据的机会调节。Aminophylline 很快并且高效地从小肠被吸收。当尽管有效吸收从上升冒号被观察,结肠的吸收被差的水条件限制时。这为修改版本的明确的表达以及其他的剂量形式的合理开发提供一个机会。
Background A patented remote controlled capsule (RCC) has recently been developed to provide noninvasive drug delivery to selected sites in the human gut that allows assessment of regional gastrointestinal (GI) drug absorption under a normal physiological environment. The objective of this study was to investigate the rate and extent of aminophylline absorption after site-specific delivery of the drug in the GI tract using RCC and a magnetic marker monitoring (MMM) technique. Methods This study was conducted in twelve healthy male subjects, in a three-treatment, randomized, crossover manner with a 7-day washout. Eligible subjects received a 150 mg aminophylline dose through an oral administration, or via a remote controlled capsule, delivered to the small bowel or ascending colon. MMM was employed to monitor the GI transit of the RCC, and the radio-frequency signal was used to activate capsules at target sites. Blood samples were obtained at regular intervals until 24 hours post dose/activation. Plasma theophylline concentrations were measured by a TDx~ System Analyzer. A comparison of the PK profile with the oral dosing route of aminophylline was performed after delivery to the small bowel and colon. Results The RCC was well tolerated in volunteers. The mean capsule activation time for the small bowel and ascending colon was 2.07 hours and 6.08 hours post dose. Aminophylline had similar absorption profiles from the small bowel compared with the stomach, with an area under the curve (AUCt) ratio of 92% vs. the stomach, but a lower absorption profile from the ascending colon, with an AUCt ratio of 47.2% vs. the stomach. Conclusions The proprietary of the RCC and MMM technique offer the opportunity to obtain data on the intestinal absorption of a drug in humans under noninvasive conditions. Aminophylline is rapidly and efficiently absorbed from the small bowel. While colonic absorption was limited by the poor water condition although effective absorption was observed from the ascending colon. This p