Examples: vials, ampoules, sachets, containing solid dose forms such as powders or granules which may or may not be dissolved before administration
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.
Strength is expressed as "per one unit of presentation" and the presentation strength and the concentration are exactly the same.
Example 1: A pack of 10 vials each containing 2g cefotaxime powder for solution for injection
Manufactured dose form | Powder for solution for injection | |
Unit of presentation | vial | The vial "bounds" the 2g of the dose form |
[Pack size] | 10 vials in the carton | |
Precise active ingredient | cefotaxime sodium | |
Basis of strength substance | cefotaxime | |
Presentation strength (logical) | 2 g per 1 unit of presentation | |
Presentation strength | 2 g [per 1 vial] | UCUM: 2 g per 1 each |
Concentration strength | The concentration of cefotaxime in the powder inside the vial is known to the regulatory agency but is not deemed clinically significant. |
Example 2: A pack of 50 sachets containing 4g of colestyramine powder for oral solution
Manufactured dose form | Powder for oral suspension | |
Unit of presentation | Sachet | The sachet "bounds" the 4g of the dose form |
[Pack size] | 50 sachets in the box | |
Precise active ingredient | colestyramine | |
Basis of strength substance | colestyramine | |
Presentation strength (logical) | 4 g per 1 unit of presentation | |
Presentation strength | 4 g per 1 sachet | UCUM: 4 g per 1 each |
Concentration strength | The concentration of colestyramine in the powder inside the sachet is known to the regulatory agency but not deemed clinically significant |
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