As with standard solid dosage forms, commercial DPIs are typically labeled with a label claim, which, in simple terms, is essentially the strength or dose of the product. For DPIs, however, the understanding of dose is more complex than for standard solid dosage forms because the entire labeled dose never reaches the target region of the patient’s lung; and a medical device plays a pivotal role in the delivery of the API into the body. It is important to remember that label claim, labeling and label can also have subtly different definitions, and therefore interpretations.
Defining the dosage strength for labeling of DPIs: Use, limitations and relevance of in vitro data
This article provides an overview of uniformity of delivered dose testing and labeling, and considers requirements from the USP, Ph. Eur., EMA and FDA.