Continuous presentation: Metered dose unit of presentation
Examples: various inhalers, nasal sprays, some cutaneous sprays/foams
The unit of presentation is the actuation, the “single operation of a metered-dose pump, valve or other equivalent dosing mechanism” [EDQM].
Strength is expressed as “per one unit of presentation” and the presentation strength and the concentration are exactly the same.
Example 1: A single inhaler containing a total of 200 actuations worth of salbutamol, 100 micrograms per actuation, packaged in a box
Manufactured dose form | Solution for aerosolisation | |
Unit of presentation | Actuation | |
[Pack size] | 200 actuations in the inhaler | |
Precise active ingredient | salbutamol sulphate | |
Basis of strength substance | salbutamol | |
Presentation strength (logical) | 100 mcg per 1 unit of presentation | |
Presentation strength | 100 mcg per 1 actuation | UCUM: 100 mcg per 1 each |
Concentration strength | The concentration of salbutamol sulphate in the inhalant solution inside the inhaler container is probably known to the regulatory agency but is not deemed clinically significant. |
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