Abstract
Successful drug delivery using implantable pumps may be found in over 12,500 published articles. Their versatility in delivering continuous infusion, intermittent or complex infusion protocols acutely or chronically has made them ubiquitous in drug discovery and basic research. The recent availability of iPRECIO®, a programmable, refillable, and implantable infusion pump has made it possible to carry out quantitative pharmacology (PKPD) in single animals. When combined with specialized catheters, specific administration sites have been selected. When combined with radiotelemetry, the physiologic gold standard, more sensitive and powerful means of detecting drug induced therapeutic, and/or adverse effects has been possible. Numerous application examples are cited from iPRECIO® use in Japan, United States, and Europe with iPRECIO® as an enabling drug delivery device where the refillable and programmability functionality were key benefits. The ability to start/stop drug delivery and to have control periods prior dosing made it possible to have equivalent effects at a much lower dose than previously studied. Five different iPRECIO® applications are described in detail with references to the original work where the implantable, refillable, and programmable benefits are demonstrated with their different end-points.
Highlights
Following a landmark report in 1990 that stated 40% of compounds failed clinical trials because of pharmacokinetics (PK), the pharmaceutical industry responded by integrating drug metabolism and pharmacokinetic (DMPK) scientists earlier in the drug discovery process with good success (Korfmacher, 2009)
OVERALL DISCUSSIONS AND CONCLUSION The “fail early; fail economically” model seems to be a continuing trend for Big Pharma. It requires the front loading of drug discovery with safety and efficacy studies to select and prioritize the most promising agents from the abundance of new molecular entities (NME) to enter the preclinical development stage
Even innovative drug delivery systems primarily used with approved drugs, have been used in the preclinical environment for difficult to deliver
Summary
Following a landmark report in 1990 that stated 40% of compounds failed clinical trials because of pharmacokinetics (PK), the pharmaceutical industry responded by integrating drug metabolism and pharmacokinetic (DMPK) scientists earlier in the drug discovery process with good success (Korfmacher, 2009). Over 12,500 published studies demonstrate that implantable pumps reliably deliver a wide range of test agents (vehicles and active compounds) Anonymous (2011a) These implantable pumps are passive devices which deliver a continuous infusion flow based on the model of the pump and osmotic pressures. (Yamato et al, 2010) The effect of agent/drug on animal activity compared to its baseline could be analyzed without the effect of handling and anesthesia These types of applications use only the most basic capabilities of the pump; start, stop, duration, infusion flow-rate, and the possibility to refill/exchange agents without additional surgery. More sophisticated and advanced infusion protocols have been evaluated by using the programmable nature of the iPRECIO® pumps (Abe et al, 2009) where dose response of Ang II was
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