Abstract：
PURPOSE:A novel infusion system (PatchPump®) has been developed using an electrochemical actuator and a semi-flexible container to deliver liquid formulations through an infusion set. In vitro studies characterized pump performance, and clinical studies evaluated functionality and pharmacokinetic (PK) performance in humans. METHODS:Total delivered volume and flow rate accuracy were determined in vitro by real-time gravimetric analysis. Functionality was evaluated in vivo using prototype devices delivering saline for 18 h in a clinical study enrolling 10 healthy volunteers. A second clinical study examined the PK of delivering treprostinil at an average dose of 2.3 ng/kg/min to 5 healthy volunteers for 18 h. RESULTS:Relative to a design target of 0.042 mL/hr, the average flow rate of 23 PatchPumps operating for 48 continuous hours was 0.043 ± 0.007 mL/hr as tested in vitro. In vivo functionality was confirmed by complete infusion of saline for the entire duration with only mild and transient adverse effects. PK results with an infusion rate of 0.045 mL/hr of treprostinil resulted in mean Css of 297 pg/mL and T1/2 of 4.44 h, comparable to prior studies using conventional infusion pumps. CONCLUSIONS:The results of these studies demonstrate a successful proof-of-concept for the PatchPump technology.
journal_name
Pharm Resjournal_title
Pharmaceutical researchauthors
Shaked A,Tenenbaum-Koren E,Atsmon J,Noymer Pdoi
10.1007/s11095-015-1765-4subject
Has Abstractpub_date
2016-01-01 00:00:00pages
83-91issue
1eissn
0724-8741issn
1573-904Xpii
10.1007/s11095-015-1765-4journal_volume
33pub_type
杂志文章abstract：PURPOSE:The main goal of this research was to assess the mechanical properties of APIs' polymorphic forms at the single-crystal level (piroxicam, famotidine, nifedipine, olanzapine) in order to predict their bulk deformational attributes, which are critical for some pharmaceutical technology processes. METHODS:The mec...
journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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doi：10.1007/s11095-014-1393-4
更新日期：2014-11-01 00:00:00
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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doi：10.1023/a:1021437306990
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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journal_title：Pharmaceutical research
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更新日期：2009-05-01 00:00:00
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journal_title：Pharmaceutical research
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更新日期：1993-08-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章,评审
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更新日期：2018-11-05 00:00:00
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journal_title：Pharmaceutical research
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更新日期：2003-06-01 00:00:00
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更新日期：2013-11-01 00:00:00
abstract：PURPOSE:Models to predict membrane-water partition coefficients (Kp) as a function of drug structure, membrane composition, and solution properties would be useful. This study explores the partitioning of dexamethasone (Dex) and its ionizable 21-phosphate (Dex-P) in liposomes varying in acyl chain length, physical stat...
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更新日期：2013-12-01 00:00:00
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pub_type： 杂志文章
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更新日期：2008-03-01 00:00:00
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更新日期：2016-05-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 临床试验,杂志文章
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更新日期：1996-06-01 00:00:00
abstract：PURPOSE:The objective of this study was to evaluate the in vivo consequences of glycyl-glutamate coadministration on gabapentin oral absorption. METHODS:Rats were administered gabapentin (10 mg/kg plus radiotracer) by gastric gavage, in the absence and presence of dipeptides, and by intravenous administration. Serial ...
journal_title：Pharmaceutical research
pub_type： 杂志文章
doi：10.1007/s11095-007-9272-x
更新日期：2007-08-01 00:00:00
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journal_title：Pharmaceutical research
pub_type： 杂志文章
doi：10.1023/a:1015973425708
更新日期：1988-08-01 00:00:00
