SBIR Phase II: Development of Polymer Gel-Based Indicators to Monitor the Exposure of Shipments of Pharmaceuticals to Harmful Temperatures

The broader impact/commercial potential of this Small Business Innovation Research Phase (SBIR) II project is to help detect whether pharmaceuticals about to be administered to patients have been damaged during shipment or storage by exposure to very cold temperatures close to or below the freezing temperature of water. Many pharmaceuticals, especially vaccines, lose their potency if exposed to near-freezing conditions. In light of tightening regulations with respect to the temperature-controlled storage and distribution of pharmaceuticals and changing distribution models (increase in direct-to-patient shipments), there is a critical need to demonstrate with greater reliability and in a cost-effective manner whether pharmaceuticals lose their potency due to exposure to harmful temperatures. The result of this SBIR II project will be an indicator that will provide workers along the pharmaceutical supply chain information about whether a pharmaceutical encountered harmful temperatures and the duration of such an encounter. Both harmful temperature and duration of exposure are critical pieces of data required to determine whether a pharmaceutical has been compromised. Technologies do exist that indicate whether an exposure to a harmful temperature has occurred, however, the indication of time of exposure is muddled and difficult to discern. The proposed research in this Phase II SBIR program, if successful, will offer a reliable alternative to costly electronic devices. The benefits of this device include preventing damaged product from reaching patients, helping companies remain in compliance with regulations in a cost-effective manner and reducing pharmaceutical waste. This Small Business Innovation Research Phase II project aims to develop Time Temperature Indicators (TTIs) that reliably indicate exposure of pharmaceutical shipments to harmful cold temperatures near the freezing point of water. This technology will be the first chemical-based technology capable of indicating the duration of such exposures. If a harmful exposure occurs, the combination of time and temperature data provided by these indicators can be used by the shipper to evaluate whether a pharmaceutical was truly compromised. As a result, pharmaceuticals that have been truly compromised are discarded and not administered to the patient. The patented indicators utilize a specially formulated polymer hydrogel that undergoes a volume transition from a swollen to a collapsed state upon cooling. The kinetics and the temperature dependence of the transition are highly tunable. The objectives of this Phase II project include refining formulations and synthesis methods to prepare polymer gels with highly reliable swollen-shrunken transitions. These gels will then be incorporated into specially designed housings to obtain TTI prototypes. Simple manual-driven machines will be designed to prepare the TTI prototypes. The performance of these TTIs will be validated: the company will demonstrate that these TTIs meet a minimum quality requirement. Thereafter the project will test the stability of the TTIs by measuring performance after accelerated storage and the proposed TTI prototypes will be subjected to standard transit tests. As the reliability of these indicators is a key product attribute, this project will identify the synthesis and process steps that introduce variability and address them accordingly.