• April 5, 2024

This article describes the development and validation of the Alberta Idealised Nasal Inlet (AINI), illustrating its use within existing test set-ups. It also discusses three experimental studies that demonstrate: 1) the ability of the AINI to capture in vivo deposition behavior for different nasal drug products, 2) use of the AINI to assess and optimize […]

  • April 7, 2023

The Biopharmaceutics Focus Group of the Academy of Pharmaceutical Sciences (APS) of Great Britain presented a workshop on nasal biopharmaceutics at the 2022 Drug Delivery to the Lungs Conference (DDL2022) in December 2022 in Edinburgh, UK. The aim was to bring together the scientific community to discuss challenges in the development of nasally administered therapies. […]

  • June 10, 2022

This article discusses CFD simulations of nasal spray transport and use of CFD modeling to design nasal spray devices and analyze spray delivery performance. In silico testing using CFD, guided with in vitro measurements, is a potentially valuable approach that can reduce time and costs of evaluating nasal spray delivery performance under variable usage conditions […]

  • December 7, 2021

For many years, the nasal route of administration has been used very successfully for the non-invasive delivery of small molecule drugs. The anatomy and physiology of the nasal cavity have been exploited to deliver 1) locally acting medications, to combat ailments such as seasonal and year-round allergies, 2) systemically delivered drugs, via the highly vascularized […]

  • December 1, 2020

The author provides a brief history of nasal delivery devices and their applications then look to potential uses in the future. Article topics include: device platforms, locally acting products, vaccines, systemic nasal drug delivery, patient considerations, regulatory considerations and future opportunities. In addition, the article includes a table listing samples of US FDA-approved nasal products […]

  • June 2, 2020

Now, more than ever, healthcare economics are providing the impetus for innovation and consequently we will see some non-obvious disease states being treated using the nasal route. As we better understand the relationships of particle size, delivered gas, patient anatomy, and inspiratory patterns across patient populations, we expect more optimized pulmonary delivery efficiency, expanding trans-nasal […]

  • May 23, 2019

Evaluation of device/formulation compatibility during early development is key to producing a successful nasal spray product. However, traditional tests (such as shot weight) may provide limited information by focusing mainly on spray pump performance. Further, droplet size distribution testing may fail to provide accurate measurements for certain formulations, such as those based on ethanol. In […]

  • January 28, 2019

The author suggests opportunities exist in treating additional diseases, getting involved with patients, determining aerodynamic particle size distribution, managing oropharyngeal deposition, improving nasal delivery and targeting orally inhaled products with narrow therapeutic indices.

  • May 21, 2018

Establishing bioequivalence based on pharmacokinetic (PK) and clinical endpoint studies is challenging, given systemic drug concentrations may not correlate with local therapeutic response. The United States Food and Drug Administration’s (FDA’s) Generic Drug User Fee Amendments (GDUFA) initiatives support advancing regulatory science to determine equivalence of complex and locally acting topical dosage forms. These activities […]

  • January 25, 2018

Companies are developing mobile applications that enable electronic interactions with the user and hold the promise of improved healthcare outcomes. But these developments bring a new host of regulatory and legal considerations. Companies face a challenge of maximizing their data assets while minimizing their legal and regulatory risks against the backdrop of a complex web […]