David A. Lewis1, Rob. D. Johnson1, Daniel I. Lewis1, Jacqueline Green2
1Oz-UK Limited, Chippenham, Wiltshire, UK
2Presspart Mfg Ltd, Blackburn, UK
Summary
Selection of a suitable canister during Pressurised Metered Dose Inhaler (MDI) product development is of primary importance. Canister material and surface treatment has a direct influence upon drug chemical stability and formulation physical stability. Adhesion of drug(s) to a canister’s surface during a product’s shelf-life or canister’s use-life will affect drug delivery performance metrics including content uniformity of the delivered and therapeutic dose.
This study evaluates the drug delivery performance and chemical stability of a Fluticasone Propionate suspension within HFA 134a in various canister types: Fluorocarbon Polymerised (FCP) Plasma treated, Anodised, Fluorinated Ethylene Propylene (FEP) coated, Stainless Steel, and Aluminium. The drug delivery performance was observed before and after 3-months storage of the MDIs at 40°C and 75%RH. At the 3-month time point, no significant difference was observed between the performance of plasma treated canisters and FEP coated canisters (p>0.05); both of which out-performed non-surface treated canisters. When compared to Flixotide (FPD = 44.1 ± 4.7µg) data collected during this study, no significant difference (p>0.05) was observed after 3-months valve-up storage at 40°C and 75%RH in the FPD ≤5µm for plasma treated canisters (FPD = 40.4 ± 0.8µg) and FEP coated canisters (42.2 ± 1.6). However, significant difference (p<0.05) was observed for the uncoated plain aluminium canister following storage (FPD = 33.5 ± 1.1µg).
Key Message
A Fluticasone Propionate suspension within HFA 134a was evaluated in various canister types for drug delivery performance and residual drug total can content. No significant difference was observed in the performance of plasma treated canisters and FEP coated canisters (p>0.05); both of which out-performed non-coated canisters.