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ConceptId

Term

Status

Action / Plan

Discussion

1

840651000

 Conventional release chewable capsule (dose form) Not Referenced

See https://request.ihtsdotools.org/#/requests/preview/766062?fromList=true request from  François Macary 

Hi François,

The existing Pharmaceutical dose form concept and the associated Clinical drug concept modeled using it have been inactivated and replaced because the requested changes for the Basic dose form would alter the meaning of the concepts.

The addition of an additional Administration method will be addressed at a later date; it is a change that needs to be done systematically for all affected concepts and also requires additional testing and perhaps a concept model change.

Kind regards,
Toni

2

421873001

 Conventional release oral cream (dose form) Not Referenced
Looking in browser the inactivation target is 1217290000 |Conventional release oromucosal cream (dose form)|. Can see this was added based on a request from  François Macary referencing EDQM PDF mapping; e-prescribe; e-dispense: https://request.ihtsdotools.org/#/requests/preview/767928?fromList=true
3

783749008

 Conventional release oral ointment (dose form) Not Referenced
Inactivation target is 1217289009 |Conventional release oromucosal ointment (dose form)| that was added based on a request from  François Macary referencing EDQM PDF mapping; e-prescribe; e-dispense: https://request.ihtsdotools.org/#/requests/preview/767927?fromList=true
4

1231841006

 Porous impregnated material for conventional release vapor inhalation (dose form) ReferencedPending

Mapped to EDQM: 50033100    Inhalation vapour, impregnated plug

Historical associations to active concepts:

  • 1269278009 |Porous impregnated material for conventional release pulmonary vapor inhalation (dose form)|
  • 1269279001 |Porous impregnated material for conventional release oromucosal vapor inhalation (dose form)|

Christopher Jarvis Inhalation implies pulmonary, favors replacing by 1269278009 |Porous impregnated material for conventional release pulmonary vapor inhalation (dose form)| EDQM Interested in understanding the product with more detail.

Ian Spiers The source materials defined that there was oromucosal use in nicotine cartridges. Original request from Sweden. https://www.medicines.org.uk/emc/product/4707/smpc#gref "Nicorette 15mg Inhalator: inhalation cartridge for oromucosal use"

Nicola Ingram Request was from Ireland SPC http://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0330-037-010_31072023145601.pdf  page 3 "The patient may find deep drawing or short sucks on the mouthpiece most effective – patients soon find a favoured technique. Nicotine vapour passing through the mouth is absorbed by the buccal mucosa: little reaches the lungs." Problem was that 1231841006 |Porous impregnated material for conventional release vapor inhalation (dose form)| was pulmonary dose form. Inactivation reason for  Porous impregnated material for conventional release vapor inhalation (dose form) may be incorrect (did not add corresponding clinical drug as failed release validation check). 

Julie M. James respiratory track does not include oromucosal.

Guillermo Reynoso why is the inactivation reason Outdated? Maybe an option is to maintain the more general concept and add the new ones as childrenUnder discussion

5

784575004

 Conventional release oral spray (dose form) Not Referenced

Unsure why Toni inactivated but new concept requested by François Macary 1229934008 |Conventional release emulsion for oromucosal spray (dose form)|

https://request.ihtsdotools.org/#/requests/preview/769485?fromList=true

6

784576003

 Prolonged-release intrauterine drug delivery system (dose form) Not Referenced

https://request.ihtsdotools.org/#/requests/preview/769521?fromList=true request from  François Macary 

Hi François,

Due to the types of changes being requested, the existing concept will be inactivated and replaced with a new concept instead of being updated.

Kind regards,
Toni


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