Sublingual oxytocin in a fast-dissolving tablet: human pharmacokinetic study of a novel, needle-free, temperature-stable treatment for prevention of postpartum hemorrhage

Organization Location: 
Seattle, WA, USA

Postpartum hemorrhage (PPH) continues to be a major cause of maternal mortality globally, especially in low-resource settings where most women lack access to quality, assisted delivery by skilled birth attendants and are at high risk for suffering PPH. PPH can be effectively prevented by the intramuscular delivery of oxytocin (WHO’s preferred drug of choice for PPH prevention) but issues with oxytocin stability and the administration route have limited its availability in low-resource settings. To address the challenges of stability (i.e., the refrigeration requirement) and safety (during administration) of injectable oxytocin, we have developed a heat-stable oxytocin fast-dissolving tablet (FDT) for sublingual administration. Under this project, we propose to test the effectiveness of this simple, needle-free approach to prevention of PPH by conducting a human pharmacokinetic study in South Africa. We anticipate that the successful outcome of the human pharmacokinetic study will help to draw investment from governmental and nongovernmental sources for conducting additional clinical trials and regulatory filing in South Africa. This innovative presentation in the form of an FDT will simplify the administration of oxytocin, while the added benefit of heat-stability in this format has the potential to overcome current cold-chain limitations, allowing for widespread use outside of clinical settings.

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