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 […]
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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 […]
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 […]
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.
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 […]
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 […]
Clinically relevant in vitro tests that assess regional deposition for nasal delivery devices may be advantageous in the production of new nasal drug delivery products and to accelerate the development of generic products. The article reviews various nasal airway models. In addition, it presents results of a VCU study to identify critical patient-use variables that […]
Making sure that a nasal spray pump is appropriate for the formulation and choosing a high-performing, well-characterised, and reliable device can minimize challenges and speed up time to market. This article reviews factors to consider in selecting a device.