There are many disadvantages associated with in vivo animal models and excised nasal mucosa, including ethical considerations and interspecies variability. In vitro nasal anatomical models that are more physiologically representative of the nasal cavity can be of fundamental importance to study nasal drug deposition and predict in vitro–in vivo correlation (IVIVC), a regulatory requirement for […]
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In 2022, an update to the United States Pharmacopeia (USP) General Chapter <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests introduced changes to the sampling procedures for Delivered Dose Uniformity (DDU) testing of nasal spray and nasal aerosol products. These revisions recommend the use of Dosage Unit Sampling Apparatus (DUSA) tubes […]
Nasal powders have been recognized as an opportunity to improve stability and residence time on the nasal mucosa compared with liquids, where amorphous powders favor the formulation of poorly soluble drugs with improved biopharmaceutical profile, namely faster onset of action. This article presents two case studies focused on particle engineering strategies and nasal powder formulation […]
Nasal powder formulations represent a significant stride in drug delivery innovation, offering the potential for simplified, preservative-free compositions. Increased chemical stability and enhanced capacity for higher drug loads are additional benefits offered by formulating as a dry powder. Application of established production technologies, such as spray drying, allows for the design and manufacture of readily […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]