Issue link: https://www.e-digitaleditions.com/i/1073928
Inhalation FEBRUARY 2019 9 The consequences of regional labeling requirements for DPIs The practical consequence of different regional approaches for the label claim and labeling of DPI prod- ucts is that products having identical compositions may have di erent label claims (numerical strength/dose on the device/packaging). is potential confusion is fur- ther compounded since compositionally identical prod- ucts may have di erent regional trade/brand names or brand color schemes. A good example is the pre-dispensed, dual blister strip DPI combination product from GSK named Relvar ® Ellipta ® in Europe and Breo™ Ellipta™ in the US, which contains two APIs, namely f lucticasone furoate and vilanterol trifenatate. From the publically available prod- uct information documentation, the loaded (pre-dis- pensed) dose of each API is the same in both the Euro- pean and US versions of the product. However, in terms of the numerical strength/dose on the device label, the US product uses the metered (pre-dispensed) dose, expressed in terms of API moiety, as the product label claim/strength (100/25 µg for uticasone furoate and vilanterol, respectively), whereas in Europe, the delivered dose of the API moiety is used for the product label claim/strength (92/22 µg for fluticasone furoate and vilanterol, respectively). Even though the clinical e - cacy of both products would be expected to be the same, the differing dose/strength labels between these two regional products could easily cause them to be per- as (Drug) Inhalation Powder and provide the strength as the amount per metered dose unit" and "the metered amount of the drug from a DPI is used to denote its strength, not the speci ed target delivered dose." 5 How- ever, in contrast to the EMA quality guideline, the inhalation-relevant chapters in the USP and Ph. Eur. and the 2018 FDA draft guidance do not have a speci c de nition of label claim, and only the USP suggests that the label claim is usually the pre-metered or metered dose of the drug. Such di erent approaches make the development of any uni ed concept of label claim chal- lenging, not only from a labeling perspective, but also, importantly, for the understanding of the dose of DPIs. While it does seem clear that the metered dose or the delivered dose is to be used in the label claim/labeling of DPIs, it is interesting to note that the EMA quality guideline does state that the labeling can be an alter- native to the delivered dose, and gives the example of ne particle mass. 1 Even so, the overwhelming major- ity of marketed DPIs are labeled based on the metered or delivered dose. Generally, at least in Europe, it appears that the expectation for label claim/labeling of DPIs is that of delivered dose. In contrast, in the US, the 2018 US draft guidance states that for DPIs, the labeling should contain the amount per metered dose unit with additional information, such as the target delivered dose, with corresponding speci ed in vitro test conditions, to be contained in the prescrib- ing information of the product. 5 AT T E N D • P R E S E N T • E X H I B I T • S P O N S O R www.rddonline.com/rddeurope2019 RDD Europe is a conference jointly organized by MAY 7 - 10, 2019 Estoril (Lisbon), PORTUGAL