Continuous presentation: Metered dose unit of presentation

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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