Drug Delivery: Enabling Technology for Drug Discovery and Development. iPRECIO® Micro Infusion Pump: Programmable, Refillable, and Implantable

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.

[1]  M. Zaretskaia,et al.  Stress-free microinjections in conscious rats , 2011, Journal of Neuroscience Methods.

[2]  Martin Wehling,et al.  Assessing the translatability of drug projects: what needs to be scored to predict success? , 2009, Nature Reviews Drug Discovery.

[3]  S. Gad,et al.  Nonclinical Vehicle Use in Studies by Multiple Routes in Multiple Species , 2006, International journal of toxicology.

[4]  Chikara Abe,et al.  A novel type of implantable and programmable infusion pump for small laboratory animals. , 2009, Journal of pharmacological and toxicological methods.

[5]  T. Abribat,et al.  The rise and rise of drug delivery , 2005, Nature Reviews Drug Discovery.

[6]  Walter A. Korfmacher,et al.  Advances in the integration of drug metabolism into the lead optimization paradigm. , 2009, Mini reviews in medicinal chemistry.

[7]  John Higgins,et al.  Strategies for bringing drug delivery tools into discovery. , 2011, International journal of pharmaceutics.

[8]  Seshadri Neervannan,et al.  Preclinical formulations for discovery and toxicology: physicochemical challenges , 2006, Expert opinion on drug metabolism & toxicology.

[9]  R. Strickley Solubilizing Excipients in Oral and Injectable Formulations , 2004, Pharmaceutical Research.

[10]  Johan Gabrielsson,et al.  Optimising in vivo pharmacology studies--Practical PKPD considerations. , 2010, Journal of pharmacological and toxicological methods.

[11]  Katsuya Harada,et al.  Chronic treatment with olanzapine via a novel infusion pump induces adiposity in male rats. , 2011, Life sciences.

[12]  Chikara Abe,et al.  Vestibular-mediated increase in central serotonin plays an important role in hypergravity-induced hypophagia in rats. , 2010, Journal of applied physiology.

[13]  Johan Gabrielsson,et al.  Pharmacokinetic-pharmacodynamic reasoning in drug discovery and early development. , 2009, Future medicinal chemistry.

[14]  V. Pillay,et al.  Drug delivery technologies for chronotherapeutic applications , 2009, Pharmaceutical development and technology.

[15]  T. Kenakin Statistics and Experimental Design , 2019, A Pharmacology Primer.

[16]  D. K. Walker,et al.  The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development. , 2004, British journal of clinical pharmacology.

[17]  Richard A. Greenberg,et al.  Statistics and Experimental Design , 1970, The Yale Journal of Biology and Medicine.

[18]  Ping Li,et al.  Developing early formulations: practice and perspective. , 2007, International journal of pharmaceutics.

[19]  R. Strickley Formulation in Drug Discovery , 2008 .

[20]  Jochen Maas,et al.  An integrated early formulation strategy--from hit evaluation to preclinical candidate profiling. , 2007, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[21]  I. Inglis,et al.  Refining procedures for the administration of substances , 2001, Laboratory animals.

[22]  E. Kwong,et al.  Strategies at the interface of drug discovery and development: early optimization of the solid state phase and preclinical toxicology formulation for potential drug candidates. , 2010, Journal of medicinal chemistry.

[23]  M. Wehling,et al.  The translatability of animal models for clinical development: biomarkers and disease models. , 2010, Current opinion in pharmacology.

[24]  Brian Samas,et al.  An intravenous formulation decision tree for discovery compound formulation development. , 2003, International journal of pharmaceutics.

[25]  D. Gustafson,et al.  Optimizing preclinical study design in oncology research. , 2011, Chemico-biological interactions.