At least two countries have extracts for potential promotion, and the use case isn’t clear as to how specific the concept needs to be.
Must the part of the plant be specified (root, seed, flower, bark, etc.)?
It is specified in drug/SPC labels.
However, of the 93 extract substances in the international edition, it’s often not specified (neither is it specified in the country’s potential promotions).
Must the extraction method (e.g., alcohol, water, CO2) be specified?
What about the form (powder, dry or soft extract, tincture, etc.)?
I don’t think we should mandate the part of the plant (or other organism) from which the extract originates. It’d might be nice. But often it’s not specified. We could make a good guess - but then your committing the modeller to something they might not align with the registration details. Here’s a snippet from the TGA’s Ingredient List:
It’s not being ambiguous. It’s being less specific - which is what the SNOMED CT hierarchy does.
Consider if somebody has an allergy to a plant - it’s just to some substance in the plant. We’re generally not concerned about what specific part.
But sometimes it is useful, especially when various parts of the same plant are consumed (Coriander/Cilantro)
So allow both.
Extract method - I’ve never encountered this detail. I think you’d need a compelling use case to get this precise beyond a handful of possible exceptions.
Form - Again, I think it should allowed but not mandatory. The available specifics can vary bewteen products, brands and jurisdictions. Sometimes it’s just a mess.
The TGA List (random examples):
Are their simplest we just want to say these “substances with some biological origin of an organism”. But if we know the specific part - that be stated as the parent.
I agree Matt. You can’t mandate that the part of plant, or even whole plant is included in the term or modelling. All we can do is allow it to be stated where it is known and presumably is important. For example 33751211000001102 |Agnus castus fruit extract (substance)|
Eur. also includes Agnus Castus Fruit Dry Extract.
Ph. Eur. 11 ( Agnus Castus Fruit ). The whole, ripe, dried fruit of Vitex agnus-castus . It contains not less than 0.08% of casticin (C19H18 O8 = 374.3), calculated with reference to the dried drug. Protect from light.
USP 2023 ( Chaste Tree ). The dried ripe fruits of Vitex agnus-castus (Verbenaceae). It contains not less than 0.05% of agnuside and not less than 0.08% of casticin, calculated on the dried basis.
So you can have both the dried fruit, and an extract. All within formal pharmacopoeias.
For the extract, again include where known and where it makes a difference.
699003 |Coal tar extract (substance)|
3588311000001108 |Coal tar extract alcoholic (substance)|
The Coal tar extract could be done using a number of solvents as Coal tar is slightly soluble in water; partly soluble in absolute alcohol, in chloroform, in ether, and in volatile oils
Where possible, the part of the plant (whole, leaf, root, etc.) and its form (powder, extract, tincture, etc.) should be mentioned in the description of the substance in order to be as clear as possible. European and international monographs demonstrate this.
Thanks to everyone for their responses. We will create a policy based on these comments that allow a broad description of the substance used in an extract.
