GDUFA Research Outcomes

Nasal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.

• All(103)
• Posters(15)
• Presentations(53)
• Papers(35)

• A CFD-PBPK Model to Simulate Nasal Absorption and Systemic Bioavailability of Intranasal Fluticasone Propionate

  Schroeter, Jeffry; Kimbell, Julia; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar

• A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray

  Schroeter, Jeffry; Stricklin, Daniela; Kimbell, Julia; Delvadia, Renishkumar; Zhang, Xinyuan

• The Impact Of Actuation Force On Droplet Size Distribution And Spray Duration Of Three Commercially Available Nasal Sprays

  Schroeter, Jeffry; Kimbell, Julia; Saluja, Bhawana; Delvadia, Renishkumar; Vallorz-III, Ernest; Sheth, Poonam

• In Vitro Investigation of Regional Nasal Drug Delivery using Two Glucocorticoid Nasal Spray Products and Twenty Anatomical Nasal Replicas

  Manniello, Michele; Hosseini, Sana; Hindle, Michael; Schuman, Theodore; Longest, Worth; Sandell, Dennis; Golshahi, Laleh

• How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays

  Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth

• Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition

  Kolanjiyil, Arun; Hosseini, Sana; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Golshahi, Laleh; Longest, Worth

• Estimating Size-specific Numbers of Active Pharmaceutical Ingredient Particles in the Regional Deposition of a Nasal Spray

  Kimbell, Julia; Schroeter, Jeffry; Tian, Geng; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar

• Effect of Actuation Force on Simulated Regional Nasal Spray Deposition in a Healthy Nasal Cavity

  Kimbell, Julia; Schroeter, Jeffry; Sheth, Poonam; Tian, Geng; Delvadia, Renishkumar; Saluja, Bhawana; Walenga, Ross

• Simulating Nasal Spray Deposition: Effects of Spray Nozzle Presence in the Nasal Vestibule

  Kimbell, Julia; Stricklin, Daniela; Schroeter, Jeffry

• Assessment of Internal Nasal Valve Using Anatomically-Accurate 3D Airway Models

  Hosseini, Sana; Schuman, Theodore; Walenga, Ross; Babiskin, Andrew; Golshahi, Laleh