Development and validation of a compact on-person storage device (SMHeartCard) for emergency access to acetylsalicylic acid and nitroglycerin.

BACKGROUND

Guidelines recommend that patients with coronary artery disease (CAD) carry and immediately use acetylsalicylic acid (ASA) and sublingually administered nitroglycerin at the onset of chest pain; however, compliance with these recommendations is poor. We designed and tested a compact on-person storage device for these medications.

METHODS

We designed an airtight, light-proof and chemically inert holder to carry four 81-mg ASA tablets and three 0.3-mg Nitrostat (nitroglycerin, Pfizer) tablets. After establishing the temperatures ranges in wallets and pockets, we tested nitroglycerin dissolution and release of the stored Nitrostat tablets across a range of relevant temperatures and a variety of tablet enclosure systems.

RESULTS

Microcalorimeter thermal conduction studies as well as dissolution and release testing showed that nitroglycerin tablets were stable at temperatures ranging from -20°C to 60°C for 1 week. In testing up to 24 weeks, 0.3-mg Nitrostat tablets enclosed completely in polytetrafluoroethylene (PTFE) performed similarly to those stored in the manufacturer's borosilicate glass packaging across a wide range of temperatures relevant to on-person carriage. Real-world on-person testing for 24 weeks confirmed these results. Non-PTFE enclosures performed poorly.

INTERPRETATION: The PTFE enclosure with a PTFE-coated cap liner maintained long-term performance of 0.3-mg Nitrostat tablets under laboratory and real-world conditions. This storage device is now commercially available as the SMHeartCard to improve compliance and provide immediate access to emergency cardiac medications.