Carriers for DPIs: formulation and regulatory challenges.

Lactose, in particular alpha-lactose monohydrate, is typically used as ‘the’ carrier in dry powder inhalers. Even though these often tailored materials allow the delivery of medicines to the body in doses that are much lower than by ‘conventional’ solid dosage forms, the use of this excipient in this application is posing characterization and regulatory challenges to both suppliers and users. [ABSTRACT FROM AUTHOR]