Continuous presentation: bounded by container; liquid/semi-solid dose forms; concentration strength

Examples: bulk parenteral solutions, insulins, patches

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. However, although presentation strength is expressed as "per one unit of presentation", the clinically relevant strength is the concentration strength, as almost all are used in individually calculated and variable amounts. Note that the unit of presentation is likely to be useful in description of the medicinal product concept at some level; insulin presented in a multi-dose vial will be used/administered differently from insulin presented in a cartridge for use within a "pen device".

Example: A pack of 5 cartridges each containing 1.5mL soluble human insulin 100 units/mL solution for injection

Manufactured dose form	Solution for injection
Unit of presentation	Cartridge	The vial "bounds" the liquid
[Pack size]	5 cartridges in a sleeve,1 sleeve in the box
Precise active ingredient	insulin soluble human
Basis of strength substance	insulin soluble human
Presentation strength (logical)	150 units per volume contained in the unit of presentation	The amount of the dose form bounded in the unit of presentation
Presentation strength	150 units per 1.5 mL	Not a clinically safe expression of strength
Concentration strength	100 units per 1 mL

Example: Box of 10 bags of Sodium chloride 0.9% solution for infusion 500mL

Manufactured dose form	Solution for injection
Unit of presentation	Bag	The bag "bounds" the liquid
[Pack size]	1 bag in a sterile pouch,10 pouches in the box
Precise active ingredient	sodium chloride
Basis of strength substance	sodium chloride
Presentation strength (logical)	450 mg per volume contained in the unit of presentation	The amount of the dose form bounded in the unit of presentation
Presentation strength	450 mg per 500 mL	Not a clinically safe expression of strength
Concentration strength	9 mg per 1 mL	Synonym: 0.9% w/v

Example: A pack of 30 sachets each containing a transdermal patch delivering 4.6mg per 24 hours of rivastigmine

Manufactured dose form	Transdermal patch
Unit of presentation	Patch	The patch "bounds" the dose form that delivers the medication
[Pack size]	1 patch in sachet, 30 sachets in the box
Precise active ingredient	rivastigmine
Basis of strength substance	rivastigmine
Presentation strength (logical)	9 g per volume contained in the unit of presentation	The amount of the dose form bounded in the unit of presentation
Presentation strength	9 g per (5cm) patch	Not a clinically safe expression of strength
Concentration strength	4.6 mg per 24 hours	This is a "rate" strength

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