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 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 2: A 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 3: 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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