Investigating Storage Options for Pressurized Metered Dose Inhalers

Selecting an appropriate closure system for a pressurized metered dose inhaler is critical for the maintenance of product integrity and safety, over an extended period.

This paper describes a study of the performance of 12 different valve configurations with a fluticasone propionate/salmeterol xinafoate formulation. Via a Design of Experiments study, accelerated testing was carried out by subjecting the samples to extreme stress (50oC/75%RH) over a period of two weeks. A comparison with data generated over a period of 3 months under more benign storage conditions indicates that the shorter testing protocol provides useful, relevant data. It could therefore be used to efficiently inform valve configuration choice in the early stages of product development, to screen more options in a short timeframe and accelerate progress.