The Count of active ingredient (attribute) relationship has been added to certain single-ingredient valproic acid or sodium valproate clinical drug concepts to prevent incorrect subsumption under multiple-ingredient concepts (such as those containing both sodium valproate and valproic acid). This modeling ensures correct classification, particularly when substances share a base moiety but differ at the modification level.
For example,
765633006 |Product containing precisely sodium valproate 200 milligram/1 each prolonged-release oral tablet (clinical drug)| includes a |Count of active ingredient (attribute)| to prevent it from being inferred as a parent of 1204385002 |Product containing precisely sodium valproate 200 milligram and valproic acid 87 milligram/1 each prolonged-release oral tablet (clinical drug)|.
In addition, when any concept in a sibling set requires the additional |Count of active ingredient| attribute to classify correctly, this attribute should also be added to all sibling concepts for consistency.
When a clinical drug has a BoSS specified in a Summary of Product Characteristics as an anhydrous substance, the PAI is represented as the unmodified substance, i.e., the substance with an unspecified level of hydration.
For example,
1153520006 |Product containing precisely carbidopa anhydrous (as carbidopa) 25 milligram and levodopa 250 milligram/1 each conventional release oral tablet (clinical drug)|
states each tablet "contains 27.0 mg carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa." The BoSS is anhydrous carbidopa, so the PAI is Carbidopa.
1331919008 |Product containing precisely carbidopa anhydrous (as carbidopa) 12.5 milligram and entacapone 200 milligram and levodopa 50 milligram/1 each conventional release oral tablet (clinical drug)|
states, "Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (as 13.5 mg carbidopa monohydrate) and 200 mg of entacapone." The Boss is anhydrous carbidopa, so the PAI is Carbidopa.
Prolonged-release transdermal patch clinical drug concepts modeled previously using concentration strength normalized to per 1 hour will use presentation strength based on the labeled total amount delivered over time (e.g., /16, /24 [usual manufacturer-documented period], /72 hours), in alignment with product SPCs and international editorial policy.
Opioid patches (e.g., fentanyl, buprenorphine) are an exception and must retain the /1 hour expression, consistent with manufacturer documentation and regulatory standards. This reflects patient safety requirements for these strong, controlled substances. These concepts must also be modeled using presentation strength.
Presentation strength is to be used for all prolonged-release transdermal patch concepts.
The |Has unit of presentation (attribute)| with a value of |Patch (unit of presentation)| is added to all prolonged-release transdermal patch concepts.
Units will reflect the duration, strength, and units as specified in the SPC.