Examples: oral solutions, suspensions, emulsions, syrups
This is a variation on the metered dose presentation; the unit of presentation supplied by the manufacturer to provide the “metered dose” is the 5mL spoonful, since this represents “the quantity of product that is administered by filling a single spoon administration device” [EDQM]. Strength is expressed as “per one unit of presentation” (per 5 mL [spoonful]) BUT the presentation strength and the concentration are NOT the same, since these are continuous liquids, so the concentration strength of “per 1 mL” will usually be a different value. Note that explicit representation of the medicine spoon would be as an administration device, and is therefore out of scope of the international Medicinal Product hierarchy. National extensions may wish to represent the inclusion of a medicine spoon (or indeed any other administration device such as an applicator) in the package description (as in IDMP, for example) should the use case(s) require.
Example: A bottle of 125 mL of aciclovir oral suspension 200mg/5mL
Manufactured dose form | Oral suspension | |
Unit of presentation | 5 mL [spoonful] | |
[Pack size] | 125 mL in the bottle | Not usually expressed as 25 spoonfuls! |
Precise active ingredient | aciclovir | |
Basis of strength substance | aciclovir | |
Presentation strength (logical) | 200 mg per 1 unit of presentation | |
Presentation strength | 200 mg per 5 mL | |
Concentration strength | 40 mg per 1 mL |
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