Various names and descriptive terms have been been used to define the MAP delivery system. To ensure clear and effective communication within and between developers and regulatory bodies we, as a community of stakeholders, must establish consensus on appropriate nomenclature and a definition for the dosage form. Whilst we recognise that there is a diverse range of MAP products in development, which are often sub-categorised using terms such as ‘coat and poke’, ‘poke and dissolve’ and ‘poke and release’, the RWG's aim is to define the principal dosage form. Literature review, individual inputs from RWG members and extensive discussions have lead to iterative development of a working draft name and definition for the delivery system.
NOMENCLATURE
What is the most appropriate 'label name' for this dosage form (i.e. the name that we assign to products for regulatory purposes)?
BACKGROUND INFORMATION
Guidance from relevant regulatory bodies was consulted to determine how to constrict a label name for the delivery system. The United Stated Pharmacopoeia (USP) provides guidance on how to structure medicinal product names:
[DRUG] [ROUTE OF ADMINISTRATION] [DOSAGE FORM]
e.g. [drug] [transdermal] [delivery system]
e.g. [drug] [transdermal] [delivery system]
Link to USP nomenclature guidelines:
www.usp.org/sites/default/files/usp/document/about/expert-volunteers/expert-committees/nomenclature-guideline.pdf
The [DRUG] name is dependent on the specific product. The RWG has therefore focused its attention on the [ROUTE OF ADMINISTRATION] and [DOSAGE FORM] components of the name. During development, the [DOSAGE FORM] term was sub-divided into two parts to enable more accurate and effective description.
www.usp.org/sites/default/files/usp/document/about/expert-volunteers/expert-committees/nomenclature-guideline.pdf
The [DRUG] name is dependent on the specific product. The RWG has therefore focused its attention on the [ROUTE OF ADMINISTRATION] and [DOSAGE FORM] components of the name. During development, the [DOSAGE FORM] term was sub-divided into two parts to enable more accurate and effective description.
WORKING DRAFT (for consultation)
Therefore, depending on the clinical application (systemic or local targeting) and territory, the dosage form may be referred to differently e.g. a Transdermal Microneedle Array Patch or Transdermal Microneedle Array Delivery System.
DEFINITION
How do we define and describe this novel delivery system?
BACKGROUND INFORMATION
Published guidance and guidelines from international regulatory agencies provided the RWG with examples of definitions to describe related dosage forms and were used to prompt discussions e.g. transdermal patches (EMA guideline on quality of transdermal patches, 2014; www.ema.europa.eu/en/quality-transdermal-patches), microneedling (Regulatory considerations for Microneedling Devices, FDA draft guidance, 2017; www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-microneedling-devices).
WORKING DRAFT (for consultation)
A definition for microneedle-based products that combine the microneedle device and API, in solid or semi-solid form, in a single entity and are designed for application to the skin.
Page updated 15 September 2023
