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Gliffy Diagram size 800 displayName Ingredient substance attributes name Ingredient substance attributes pagePin 2
Figure 4146: Ingredient role attributes
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A medicinal product concept has a set of precise active ingredient substance(s), those substance(s) that provides the therapeutic effect of the medicinal product and which are described using the fullest and most specific description of the substance as it is used in the product(s) that the concept represents (as they are presented by the manufacturer in the manufactured dose form, before any dilution or transformation). The precise active ingredient substance may include various modifiers, such as salts, esters and/or polymers (e.g. pegylation); not all substances, even when used as the precise active ingredient substance, have a modification (see axitnitib). This is the attribute role that is used in the definition of the MP (precisely) concept, and in the definition of the CD (precisely).
Examples:
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- haloperidol decanoate
- esomeprazole magnesium dihydrate
- oxybutynin chloride
- paroxetine hydrochloride isopropyl solvate
- dexamethasone sodium phosphate
- sorafenib tosylate
- axitinib
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Figure 4247: Ingredient role chaining
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Figure 4348: Ingredient role chaining example
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Gliffy Diagram macroId 0061e818-746e-490c-b70d-655dbfe4589c displayName IDMP Substance Ingredient role name IDMP Substance Ingredient role pagePin 1
Figure 4449: Ingredient role in ISO 11615 of IDMP
Ingredient role is a specific attribute in ISO 11615 in IDMP, but no vocabulary/value set was specified in the conceptual standard for the ingredient roles. Examples that have been given include "active", "inactive" and "adjuvant". This supports the regulatory listing of all the substances present in a product, with their basic role (therapeutic or otherwise).
The explicit use of ingredient roles in the medicinal product model is compatible with the IDMP conceptual model; however, the relationship of ingredient role to substance strength is still being elucidated in IDMP. Note that the concept of "basis of strength substance", in the very few cases where it is not actually a substance present in the product, is managed by the use of the Reference Substance class in IDMP. See also IDMP Compatibility for Clinical Drug (Clinical Drug (CD)).
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