Developing Ways to Evaluate in the Laboratory How Inhalation Devices Will Be Used by Patients and Care-Givers: The Need for Clinically Appropriate Testing

摘要

The design of methods in the pharmaceutical compendia for the laboratory-based evaluation of orally inhaled product (OIP) performance is intentionally aimed for simplicity and robustness in order to achieve the high degree of accuracy and precision required for the assurance of product quality in a regulated environment. Consequently, performance of the inhaler when used or even misused by the patient or care-giver has often not been assessed. Indeed, patient-use-based methodology has been developed in a somewhat piecemeal basis when a need has been perceived by the developing organization. There is, therefore, a lack of in-use test standardization across OIP platforms, and often important details have remained undisclosed beyond the sponsoring organization. The advent of international standards, such as ISO 20072:2009, that focus specifically on the OIP development process, together with the need to make these drug delivery devices more patient-friendly as an aid to improving compliance, is necessitating that clinically appropriate test procedures be standardized at the OIP class level. It is also important that their capabilities and limitations are well understood by stakeholders involved in the process. This article outlines how this process might take place, drawing on current examples in which significant advances in methodology have been achieved. Ideally, it is hoped that such procedures, once appropriately validated, might eventually become incorporated into the pharmacopeial literature as a resource for future inhaler developers, regulatory agencies, and clinicians seeking to understand how these devices will perform in use to augment ongoing product quality testing which is adequately served by existing methods.