Uniformity of delivered dose for pressurised metered dose inhalers

Jim Clay and Andy Cooper from 3M investigate pMDI uniformity of delivered dose method development using an automated dose collection apparatus

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The methodology for uniformity of delivered dose (UoDD) or dose content uniformity (DCU) is a Critical Quality Attribute (CQA) of Orally Inhaled and Nasal Drug Products (OINDP).

The UoDD and DCU methodology is sensitive to user-operation variability associated with the shaking and actuation process of pressurised metered dose inhalers (pMDIs).

The analytical method therefore requires control of these parameters for the priming, dose collection and waste actuations.

During the development of the analytical methodology, the priming and dose collection actuations are typically performed by an analyst, with automation being used only for the waste actuations that are performed between the stages of container life where the dose collection actuations are performed.

The aim of this study is to understand if automation can be extended to the dose collection actuations, using the Vertus from Novi Systems Ltd, and also the priming actuations.

Download to full paper here.

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