Assessing the adaptability of bench scale dry powder technology for filling of an pMDI can with a high fill weight API
Sheryl Johnson1, James Murray1, Johnathan Carr1, Marco Laackmann2, Daniel-Jakub Wilhelm2, Tony Clark3, Cristino Ruano3.
1Koura Global, Pool lane, Ince, Cheshire, CH2 4NU, UK
2Harro Höfliger, Helmholzstraße 4, 71573 Allmersbach i.T., Germany
3Pharmatec solutions ltd, Timberly, Gyfelia, Wrexham. LL13 0YH, UK
Due to the present tightening of environmental legislations governing medical propellants, there is more emphasis than ever on understanding the manufacturing steps required in handling of low global warming potential (GWP) propellants. This paper explores one such approach that aims to mitigate safety concerns at the formulation manufacturing stage, brought about by the flammability of the novel propellants. By first proving the adaptability of dry powder filling equipment in filling pMDI cans at the bench scale, the ability to separate the drug dosing and propellant filling stages can be assessed. The use of such technology to dispense a high fill weight API, resulted in data that met precision limits outlined (±10%). Optimised trial dosages all fell within 6% of the target weight with low RSD values of 1.7-2.1%. The next step is to determine if formulations manufactured using this technique are of equivalent in-vitro performance to those made using traditional bench filling techniques.
Bench scale dry powder filling equipment can be effortlessly adapted to dispense Salbutamol Sulphate for pMDI formulations with accurate and precise results. This could help to adapt how the industry approaches pMDI filling at manufacturing scale, particularly for low global warming potential (GWP) propellants and goes some way to mitigate the risks associated with flammability.