Phase I Clinical Evaluation of Inhaled Oxytocin

Monash University
Organization Location: 
Clayton, Austrailia

This project will involve the development of a novel aerosol delivery system for oxytocin that can be inhaled by patients from a simple, disposable device immediately after childbirth for the management of postpartum hemorrhage (PPH). This approach will address several of the current roadblocks to healthy pregnancies by (a) providing a more stable formulation of oxytocin that does not require cold-chain storage, and (b) removing the need for highly trained health workers for administration. This innovation will bring an effective, affordable solution to communities that lack quality health services. With this product we aim to increase access to oxytocin in resource-poor settings and improve the management of PPH and subsequent maternal health outcomes. A recent study reported that if oxytocin was available for active management of PPH in all facility and non-facility births it would be possible to prevent 41m cases of PPH and save 2m lives over a 10-year period. The creative aspect of this idea is the recognition that a specialist particle engineering approach can be employed to formulate oxytocin as a heat-stable, dry powder for inhalation. This potentially provides a product that will be as effective as an intramuscular (IM) injection, but that is better suited to use in resource-poor settings. As such, the approval of such a product would dramatically increase access to the current gold standard therapy for the management of PPH.

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