Continuous presentation: bounded by container; liquid dose forms

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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