Inhalation device options for the management of chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms and airflow limitation, resulting from abnormalities in the airway and/or damage to the alveoli. Primary care physicians manage the healthcare of a large proportion of patients with COPD. In addition to determining the most appropriate medication regimen, which usually includes inhaled bronchodilators with or without inhaled corticosteroids, physicians are charged with optimizing inhalation device selection to facilitate effective drug delivery and patient adherence. The large variety of inhalation devices currently available present numerous challenges for physicians that include: (1) gaining knowledge of and proficiency with operating different device classes; (2) identifying the most appropriate inhalation device for the patient; and (3) providing the necessary education and training for patients on device use. This review provides an overview of the inhalation device types currently available in the United States for delivery of COPD medications, including information on their successful operation and respective advantages and disadvantages, factors to consider in matching a device to an individual patient, the need for device training for patients and physicians, and guidance for improving treatment adherence. Finally, the review will discuss established and novel tools and technology that may aid physicians in improving education and promoting better adherence to therapy.

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

This March 2009 Workshop Summary Report was sponsored by Product Quality Research Institute (PQRI) based on a proposal by the Inhalation and Nasal Technology Focus Group (INTFG) of the American Association of Pharmaceutical Scientists (AAPS). Participants from the pharmaceutical industry, academia and regulatory bodies from the United States, Europe, India, and Brazil attended the workshop with the objective of presenting, reviewing, and discussing recommendations for demonstrating bioequivalence (BE) that may be considered in the development of orally inhaled drug products and regulatory guidances for new drug applications (NDAs), abbreviated NDAs (ANDAs), and postapproval changes. The workshop addressed areas related to in vitro approaches to demonstrating BE, biomarker strategies, imaging techniques, in vivo approaches to establishing local delivery equivalence and device design similarity. The workshop presented material that provided a baseline for the current understanding of orally inhaled drug products (OIPs) and identified gaps in knowledge and consensus that, if answered, might allow the design of a robust, streamlined method for the BE assessment of locally acting inhalation drugs. These included the following: (1) cascade impactor (CI) studies are not a good 2 predictor of the pulmonary dose; more detailed studies on in vitro/in vivo correlations (e.g., suitability of CI studies for assessing differences in the regional deposition) are needed; (2) there is a lack of consensus on the appropriate statistical methods for assessing in vitro results; (3) fully validated and standardized imaging methods, while capable of providing information on pulmonary dose and regional deposition, might not be applicable to the BE of inhaled products mainly due to the problems of having access to radiolabeled innovator product; (4) if alternatives to current methods for establishing local delivery BE of OIPs cannot be established, biomarkers (pharmacodynamic or clinical endpoints) with a sufficiently steep dose-response need to be identified and validated for all relevant drug classes; and (5) the utility of pharmacokinetic studies for evaluating "local pulmonary delivery" equivalence deserves more attention. A summary of action items for seminars and working groups to address these topics in the future is also presented.