One of the four Critical Quality Attributes (CQAs) that determine the safety, quality and efficacy of orally inhaled and nasal drug products (OINDPs), delivered dose is the total amount of drug emitted from the drug device that is available to the user, when the device is actuated correctly. The uniformity of the delivered dose, or DDU, must be ensured within and between devices. DDU is measured by firing the test device into a sampling apparatus which contains a filter. The active drug caught on the filter is then dissolved in solvent and analysed using High Pressure Liquid Chromatography (HPLC). Depending on the type of OINDP under test, different apparatus set-ups are required.
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