Thomas Moody1, Mark Parry1, Josh Rigby1, Abbey Grahame1, Justyna Kinga Powroznik1, Renz Rabe1 & Jamie Clayton2
1 Intertek Melbourn, Saxon Way, Melbourn SG8 6DN, UK
2 Copley Scientific Limited, Colwick Quays Business Park, Road No. 2, Nottingham, NG4 2JY, UK
Summary
Analytical testing of pMDI products presents challenges in ensuring the Shake, Hold, and Fire stages are performed correctly and consistently throughout. This study presents data looking at the impact of different shake profiles and the use of automation for emitted dose testing of a Symbicort drug product. Symbicort contains two active ingredients, budesonide (BD) and formoterol fumarate (FF). While the BD is present in solution, the FF is present as a suspension; this allows parallel examination of the impact on both solution and suspension formulations.
Two shake profiles were investigated, with stark pronounced differences in performance observed for the FF component that suggest potential over-shaking issues with Shake A, such as creaming or foaming of the suspended material. BD was not significantly impacted by the different shake profiles nor the use of automation, while the FF component highlights performance improvements when automation is applied, and where shake parameters are better suited to the product.
Automation in pMDI testing is not widely established however this study highlights it as an effective tool for minimising human factors during testing. It is important to remember that a human will still need to use the device to administer medication, and the handling process should be achievable and robust. The potential use of automation for shake development and benchmarking for user training in manual shaking is also discussed.