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

Manufactured dose formSolution for injection
Unit of presentationCartridgeThe vial "bounds" the liquid
[Pack size]5 cartridges in a sleeve,1 sleeve in the box
Precise active ingredientinsulin soluble human
Basis of strength substanceinsulin soluble human
Presentation strength (logical)150 units per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength150 units per 1.5 mLNot a clinically safe expression of strength
Concentration strength100 units per 1 mL


Example 2: A box of 10 bags of Sodium chloride 0.9% solution for infusion 500mL

Manufactured dose formSolution for injection
Unit of presentationBagThe bag "bounds" the liquid
[Pack size]1 bag in a sterile pouch,10 pouches in the box
Precise active ingredientsodium chloride
Basis of strength substancesodium chloride
Presentation strength (logical)450 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength450 mg per 500 mLNot a clinically safe expression of strength
Concentration strength9 mg per 1 mLSynonym: 0.9% w/v


Example 3: A pack of 30 sachets each containing a transdermal patch delivering 4.6mg per 24 hours of rivastigmine



Manufactured dose formTransdermal patch
Unit of presentationPatchThe patch "bounds" the dose form that delivers the medication
[Pack size]1 patch in sachet, 30 sachets in the box
Precise active ingredientrivastigmine
Basis of strength substancerivastigmine
Presentation strength (logical)9 g per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength9 g per (5cm) patchNot a clinically safe expression of strength
Concentration strength4.6 mg per 24 hoursThis is a "rate" strength



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