Abstract

Orally inhaled drug products (OIDPs) refer to a drug-device system in which drugs in the form of aerosols, powders, solutions, or suspensions are delivered into the lung via oral inhalation (1). An OIDP usually consists of two components, the drug formulation and an inhaler device which allows the administration of the drug and the deposition of active ingredients in the targeted site within patients. OIDPs show great capability of therapeutic effectiveness to treat pulmonary diseases, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and asthma (2), as well as systemic diseases, such as diabetes (3), schizophrenia (4), and Parkinson’s disease (5). Based on inhalation method, OIDPs are categorized into pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs) and the newly developed soft mist inhalers (SMIs).