Regulatory science for generic dry powder inhalers (DPIs) in the United States (US) has
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …

In silico mechanistic modeling approaches have been designed by various stakeholders
with the goal of supporting development and approval of generic orally inhaled drug …

Accurate knowledge of the delivery of locally acting drug products, such as metered-dose
inhaler (MDI) formulations, to large and small airways is essential to develop reliable in …

Dry powder inhalers (DPIs) are drug–device combination products where the complexity of
the formulation, its interaction with the device, and input from users play important roles in …

The aim of this study was to further evaluate and optimize the Transwell® system for
assessing the dissolution behavior of orally inhaled drug products (OIDPs), using fluticasone …

This study aimed to gain an in-depth understanding of the pulmonary fate of three
experimental fluticasone propionate (FP) dry powder inhaler formulations which differed in …

The composition, morphology and dissolution profile of particles and micro-sized
agglomerates delivered upon inhalation may have a significant impact on the product …

To assess bioequivalence of locally acting suspension-based nasal sprays, the US FDA
currently recommends a weight-of-evidence approach. In addition to in vitro and human …

Background In development of inhaled drugs-and formulations the measured concentration
in the systemic circulation is often used as a surrogate for local dosimetry in the lungs. To …

Almost all current orally inhaled drug products (OIDPs) are for the treatment of respiratory
diseases, and many have been designed using molecular or formulation strategies to retain …