Performance testing of a new fluid-applied fluorocarbon-bonded release coating system for inhalation hardware

P A Jinks

The creation of pressurised Metered Dose Inhaler (pMDI) product systems exhibiting consistent dosing within product tests for dosing uniformity remains the holy grail of the pMDI designer, yet undesirable deposition of active pharmaceutical ingredient/s (API/s) from suspension based formulations to system hardware continues to challenge this aim.  Although canisters featuring non-stick coatings are available which mitigate the deposition that may occur to the walls of canisters, valve deposition remains an unsolved issue. The focus of this paper is the demonstration of the performance benefits arising from the use of a new fluid-applied fluorocarbon-bonded (FAFB) coating system, to both canisters and to valve components. When applied to both stainless steel and aluminium canisters, the coating was shown to perform as well as a PTFE-lacquered canister in a rapid screening test for deposition. The coating was then applied to metal valve components and product performance was characterised in terms of through life dose uniformity. The coating produced a marked reduction in measured valve deposition which resulted in a step change improvement in dose uniformity. It is anticipated that release coatings will become increasingly used on valve components as the performance benefits that arise from the use of easily applied high performance coatings such as the one described, become more generally recognised.

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