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).
More »The proposed Drug Stability Analyzer is specifically being designed to monitor degradation of pharmaceutical drugs that are used by astronauts, so that drug types, formulations, and packaging can be improved, and supplies can be selected to match mission length. It will also have the capability of determining if a drug is suitable at the time of use (effective and safe).
Approximately 3000 medication errors occur each year due mostly to administering incorrect drugs or doses. Pharmacies are considered the last line of defense and to minimize such errors the Drug Compounding Safety Bill will soon become law. The Drug Stability Analyzer will have great value to pharmacies with its ability to confirm drug identity and dosage in 10 seconds as it is given to the customer. The analyzer will also have great value in its ability to identify counterfeit (fake) drugs. According to the World Health Organization, ~10% of all drugs sold worldwide are counterfeit (largely through the internet), and have resulted in 200,000 deaths per year. Many of the drugs sold in the US are manufactured oversees, and in recent years the standard supply chains have also been compromised.
Organizations Performing Work | Role | Type | Location |
---|---|---|---|
Real-Time Analyzers, Inc. | Lead Organization | Industry | Middletown, Connecticut |
Ames Research Center (ARC) | Supporting Organization | NASA Center | Moffett Field, California |