Sylvester Olusoji1, Mark Parry1, Alain Regard2
1Intertek Melbourn, Saxon Way, Melbourn, SG8 6DN, UK
2Nemera la Verpillière, 63 Avenue Tony Garnier, 69007 Lyon, France
Summary
This study explored the development of a nasal spray for the delivery of Semaglutide using the Nemera® UniSpray device, with the aim to assess suitability of nasal sprays for delivery of biological molecules traditionally delivered by the injectable route. Semaglutide is a GLP-1 receptor agonist used in the treatment of type 2 diabetes and obesity available most commonly in the form of an injection (Ozempic®, Wegovy®) but is also formulated as an oral tablet (RYBELSUS®). In this research, a basic Semaglutide nasal drug product was developed and characterised to assess its suitability for nasal use. Initially, a formulation composed of Semaglutide in a phosphate buffer was prepared and assessed for various attributes typical to nasal drug delivery such as pH, osmolality, single content actuation (SAC) droplet size distribution (DSD) and plume geometry. These results demonstrated acceptable feasibility for nasal delivery, and further refinement of the formulation was then explored. additional formulations were then produced introducing nasal delivery enhancing excipients such as viscosity enhancers, surfactants, and mucoadhesive compounds to explore the potential performance. From these results, several fit-for-purpose formulations that achieved the desired nasal characteristics were identified while showing good compatibility with both the drug and device.
Gary.Olusoji