CFD RESEARCH CORPORATION — Department of Health and Human Services SBIR Phase I: FDA

Description

DESCRIPTION provided by applicant Delivery of therapeutic drugs via the dermal route is a promising alternative to oral or parenteral delivery routes Dermal drug delivery systems DS offer unique advantages which include controlled release over longer durations for steady absorption into the systemic circulation reduced systemic toxicity significant reduction in first pass effects and gastrointestinal irritation The market potential of DS was valued at $ B in and is projected to reach $ B by suggesting significant investment by pharma companies in dermal drug research In response to this trend a robust simulation tool that can help predict the safety and effectiveness of new pharmaceuticals bioequivalence of generics intended for transdermal delivery will be indispensable to pharma industry to accelerate development for regulatory approval towards market launch Towards this goal we propose to develop a toolkit for andquot Computational Pharmacotherapy of Dermally Administered Compoundsandquot abbreviated CPDAC The multiscale toolkit will integrate a holistic model of dermal absorption and transport and whole body physiology based pharmacokinetics PBPK for predicting pharmacokinetics PK and pharmacodynamics PD of drugs in a unified framework The tool will be designed in a modular parametric form to accommodate subject specific physiology user defined fidelities of specific skin layers D D embedded microvasculature and tool compound formulations and different dermal delivery routes In Phase I we will predict the PK of multiple drugs for Gen delivery routes transdermal patch gel and spray and validate with literature data In Phase II we plan to extend the scope of the toolkit to include Gen field assisted transdermal systems and Gen intradermal delivery We will also develop and demonstrate intelligent algorithms to correlate the PK PD outcomes to predict the human safety and effectiveness of novel compounds tested in vitro PUBLIC HEALTH RELEVANCE Delivery of therapeutic drugs via the dermal route is a promising alternative to oral or parenteral delivery routes Dermal drug delivery systems DS offer unique advantages which include controlled release over longer durations for steady absorption into the systemic circulation reduced systemic toxicity significant reduction in first pass effects and gastrointestinal irritation The market potential of DS was valued at $ B in and is projected to reach $ B by suggesting significant investment by pharma companies in dermal drug research In response to this trend a robust simulation tool that can help predict the safety and effectiveness of new pharmaceuticals bioequivalence of generics intended for transdermal delivery will be indispensable to pharma industry to accelerate development for regulatory approval towards market launch