David A. Lewis1, Rob. D. Johnson1, Daniel I. Lewis1, Jacqueline Green2
1Oz-UK Limited, Chippenham, Wiltshire, UK
2Presspart Mfg Ltd, Blackburn, UK
Summary
Drug delivery performance and chemical stability has been evaluated for an ethanol-based budesonide solution HFA 134a MDI formulation packaged within five alternative canister types. The chemical stability of the budesonide was observed to be directly dependent upon canister choice.
Following 3-months valve-up storage at 40°C/75%RH, surface treated canisters (plasma, anodised and FEP) were observed to have a budesonide residual of 97.3 ± 0.5%, 97.5 ± 1.3% and 97.6 ± 0.6% respectively. However, under the same conditions the drug residual for the same formulation packaged in non-surface treated stainless steel and aluminium canisters was much lower; 65.5 ± 0.3% and 88.6 ± 0.6% respectively.
With regards to drug delivery performance, when packaged in Plasma treated canisters, no significant difference (p>0.05) was observed in budesonide drug delivery metrics (delivered dose, fine particle dose and MMAD) before and after 3-months valve-up storage at 40°C/75%RH.
The data presented in this study highlights the importance of selecting a suitable canister type during formulation and product development. With regards to the budesonide formulation evaluated in this study, surface treated canisters (plasma, anodised and FEP) outperformed plain stainless steel and plain aluminium canisters.
Key Message
A solution Metered Dose Inhaler (MDI) budesonide formulation has been evaluated in five alternative canister types. The chemical stability of the budesonide is observed to be directly dependent upon canister choice.