Continuous presentation: bounded by container; liquid dose forms
Examples: parenteral solutions, unit dose nebuliser solutions
The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term.
Presentation strength is expressed as "per the amount of liquid bounded by the unit of presentation" but concentration strength is per mL (and therefore is often different).
Example 1: A pack of 10 ampoules each containing 20mL of metoclopramide hydrochloride for solution for injection
Manufactured dose form | Solution for injection | |
Unit of presentation | Ampoule | The ampoule "bounds" the liquid |
[Pack size] | 10 ampoules in the box | |
Precise active ingredient | metoclopramide hydrochloride | |
Basis of strength substance | metoclopramide hydrochloride | |
Presentation strength (logical) | 100 mg per volume contained in the unit of presentation | The amount of the dose form bounded in the unit of presentation |
Presentation strength | 100 mg per 20 mL | |
Concentration strength | 5 mg per 1 mL |
Example 2: A pack of 20 UDVs each containing 2mL of ipratropium bromide for solution for nebulisation
Manufactured dose form | Solution for nebulisation | |
Unit of presentation | Unit dose vial | The vial "bounds" the liquid |
[Pack size] | 5 vials in a sleeve, 4 sleeves in the box | |
Precise active ingredient | ipratropium bromide | |
Basis of strength substance | ipratropium bromide | |
Presentation strength (logical) | 500 mcg per volume contained in the unit of presentation | The amount of the dose form bounded in the unit of presentation |
Presentation strength | 500 mcg per 2 mL | |
Concentration strength | 250 mcg per 1 mL |
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