Aspects of Particle Science and Regulation in Pharmaceutical Inhalation Drug Products

• Published in: Crystal growth & design 2005-11, Vol.5 (6), p.2261-2267
• Main Authors: Nagao, Lee M, Lyapustina, Svetlana, Munos, Melinda K, Capizzi, Mary Devlin
• Format: Article
• Language: English
• Subjects: Cross-disciplinary physics: materials science; rheology; Exact sciences and technology; Materials science; Methods of crystal growth; physics of crystal growth; Physics
• ISSN: 1528-7483; 1528-7505
• DOI: 10.1021/cg050224z

Pharmaceutical orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are used by millions of individuals worldwide to treat symptoms of asthma and chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema). Other applications of these products are being developed including inhalation delivery of insulin and medication to treat pain and the symptoms of cystic fibrosis. Analysis and control of particulate matter are important aspects of the development of these drug products. This includes the development and control of particles of drugs delivered to the patient and the characterization and control of foreign particles that may contaminate the final product. The chemistry and manufacture of these products historically have been strictly regulated by the United States Food and Drug Administration (FDA), with many challenging regulatory requirements applied to analysis and control of particles. This paper provides an overview of some of the main areas of particle analysis in inhalation drug products and the current regulatory challenges pertinent to these areas.