Summary

Description

The goal of this proposed program through Phase III is to build a space-worthy Drug Stability Analyzer that can determine the extent of drug degradation. It will be able to monitor the drug active pharmaceutical ingredient (API) and its degradation product concentrations as a function of time, as well as determine if a drug is suitable for use. This will be accomplished by designing and building a rugged, small, low mass, low power, easy to use analyzer that can identify and quantify API and degradation products with little or no sample handling in 1 minute. Feasibility was successfully demonstrated during Phase I by measuring acetaminophen, azithromycin, epinephrine, lidocaine, and their degradation products in mixtures and during reaction with a 1-4% limit of detection. The API's were also successfully measured in commercial products. During the Phase II program a prototype Drug Stability Analyzer, suitable for space deployment will be built and used to measure the degradants of all the ISS medical kit drugs (>100) with an accuracy goal of 2% and a precision goal of 1% within 1 minute. The Drug Stability Analyzer will be transitioned from a TRL 3 to a 7 (ground tested).