SMART® MEDICATION ADHERENCE FORMULATION, METHOD, DEVICE AND SYSTEM FOR TOPICAL, VAGINAL OR RECTAL ROUTES OF ADMINISTRATION

摘要

Novel compositions, methods, systems and devices are disclosed which contain markers for definitive medication adherence monitoring for Active Pharmaceutical Ingredients (APIs) delivered topically, vaginally or rectally. This invention is useful in a wide range of contexts, including, but not limited to, clinical trial settings, home use settings, or other settings, where it is necessary to definitively confirm that a given patient has taken or been administered a given medication at the correct time and in the correct dosage via a topical, vaginal or rectal route of delivery. Specific formulations of markers are disclosed for inclusion in compositions for Active Pharmaceutical Ingredient (API) delivery, including but not limited to delivery of microbicidally active compounds such that on topical, vaginal or rectal delivery, said AEM is detected in the breath or an Exhaled Drug Emplacement Marker, EDEM, which is a metabolite of the AEM, is detected in the breath.