Oxytocin is the gold standard therapy for the prevention and treatment for PPH, but currently exists only as an injection product that requires refrigerated supply and storage to maintain quality and skilled healthcare workers for safe administration. As a consequence, in resource-poor settings, where cold chain infrastructure is lacking or unreliable and the availability of skilled birth attendants limited, many women do not have access to this essential life-saving medicine.
Monash Institute of Pharmaceutical Sciences, in partnership with Janssen Pharmaceutica N.V. (a part of the Janssen Pharmaceutical Companies of Johnson & Johnson) and GlaxoSmithKline (GSK), is developing a novel, simple to use, inhaled form of oxytocin for the prevention of PPH in low and middle income countries.
Our objective is to greatly improve access to this essential medicine by designing and developing an effective inhaled oxytocin with the following attributes:
- Heat stable, requiring no refrigeration
- Non-invasive with no need for syringes, needles or other consumables
- Simple to use
Oxytocin injection must be supplied and stored at 2-8C to ensure that the quality of the product is maintained and degradation of the oxytocin does not occur. In poorly resourced settings, cold chain infrastructure to protect heat-sensitive medicines is sometimes lacking or unreliable. The result is the quality of oxytocin at the point of use can be compromised:
- In Ghana, a survey of oxytocin injection quality in four districts found 74% of ampoules (n=46) contained less than the specified concentration of oxytocin (Stanton et al. 2012)
- The Monash team and partners collected ampoules (n=256) from 15 facilities in five provinces within the Democratic Republic of Congo and 80% were shown to contain less than 90% of the required content (Lambert et al. 2018)
- The United States Pharmacopoeia-Promoting Quality of Medicines program conducted a post-marketing surveillance study in Nigeria and discovered 74% of oxytocin ampoules (n=159) failed the assay specification (Anyakora et al. 2018)
- A systematic review of studies assessing oxytocin injection quality by Torloni et al. found that 57.5% of ampoules in Africa and 22.3% of ampoules in Asia contained lower than specified concentrations of oxytocin (2016)
The inhaled oxytocin product aims to provide a product that reliably delivers the required dose of oxytocin to prevent PPH independent of storage conditions. Our powder technology shows significantly enhanced stability compared to the injection product.