Injectable oxytocin has been recommended by the World Health Organization for routine use in prevention and treatment of Postpartum hemorrhage (PPH). However, safely delivering an injection requires a trained provider and sterile equipment, ideally in a health facility setting. Additionally, delivering a lifesaving dose of oxytocin is further complicated by the poor stability of oxytocin - it is inactivated if exposed to high ambient temperatures. We propose to address both challenges by developing heat-stable oxytocin in a fast-dissolving tablet format for sublingual (under tongue) administration. Sublingual tissue is highly permeable and rich in blood supply; it is capable of producing rapid onset of action in blood, which is ideal for the short delivery period required for oxytocin. We will conduct pharmaceutical studies to develop heat-stable oxytocin and conduct preclinical (bioequivalence and bioavailability) studies in pigs to confirm feasibility of the sublingual route (in comparison to standard intramuscular administration). We will confirm heat stability of oxytocin in this format by conducting an elevated temperature stability study. The use of a fast-dissolving tablet format is intuitive and allows for safe, straightforward administration of oxytocin by patient and caregiver. Heat-stable oxytocin in a fast-dissolving tablet format for sublingual administration will significantly reduce maternal deaths from PPH.
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