Yang Guo1, Beth Laube, Richard Dalby. 1. Department of Pharmaceutical Sciences, University of Maryland at Baltimore, Baltimore, MD, USA. yang.guo@spcorp.com
Abstract
PURPOSE: This study was conducted to evaluate the effect of formulation variables and breathing patterns on aerosol distribution in the nasal cavity. METHODS:Placebo nasal spray formulations containing 0.25% w/v Avicel CL611 (viscosity = 4 cP) and 2% w/v methylcellulose (MC; viscosity = 18.2 cP) were radiolabeled with (99m)Technicium. Following spraying into a silicone nose model, through which air was drawn at one of three constant rates (0, 10, and 20 L/min) or one of two breathing profiles (representing fast and slow inhalations), aerosol deposition in the model was quantified by gamma scintigraphy. Regional deposition was expressed as horizontal[inner, middle (h), outer] and vertical distribution [upper, middle (v), lower] in the nose model. RESULTS: Compared to 2% MC, Avicel CL611 significantly increased aerosol deposition in the middle (h) region of the nasal cavity under all breathing conditions, and in the inner region at 0 and 20 L/min and with a slow inhalation. The different breathing rates showed no effect on deposition of 2% MC. However, 10 L/min significantly increased the upper deposition of Avicel compared to 0 and 20 L/min. CONCLUSIONS: Nasal sprays with a low viscosity provided greater surface coverage of the nasal mucosa than higher viscosity formulations. Changes in breathing profiles did not affect aerosol deposition in this nose model.
RCT Entities:
PURPOSE: This study was conducted to evaluate the effect of formulation variables and breathing patterns on aerosol distribution in the nasal cavity. METHODS: Placebo nasal spray formulations containing 0.25% w/v Avicel CL611 (viscosity = 4 cP) and 2% w/v methylcellulose (MC; viscosity = 18.2 cP) were radiolabeled with (99m)Technicium. Following spraying into a silicone nose model, through which air was drawn at one of three constant rates (0, 10, and 20 L/min) or one of two breathing profiles (representing fast and slow inhalations), aerosol deposition in the model was quantified by gamma scintigraphy. Regional deposition was expressed as horizontal[inner, middle (h), outer] and vertical distribution [upper, middle (v), lower] in the nose model. RESULTS: Compared to 2% MC, Avicel CL611 significantly increased aerosol deposition in the middle (h) region of the nasal cavity under all breathing conditions, and in the inner region at 0 and 20 L/min and with a slow inhalation. The different breathing rates showed no effect on deposition of 2% MC. However, 10 L/min significantly increased the upper deposition of Avicel compared to 0 and 20 L/min. CONCLUSIONS: Nasal sprays with a low viscosity provided greater surface coverage of the nasal mucosa than higher viscosity formulations. Changes in breathing profiles did not affect aerosol deposition in this nose model.
Authors: Jonathan Castile; Yu-Hui Cheng; Ben Simmons; Michael Perelman; Alan Smith; Peter Watts Journal: Drug Dev Ind Pharm Date: 2012-07-17 Impact factor: 3.225
Authors: Saikat Basu; Landon T Holbrook; Kathryn Kudlaty; Olulade Fasanmade; Jihong Wu; Alyssa Burke; Benjamin W Langworthy; Zainab Farzal; Mohammed Mamdani; William D Bennett; Jason P Fine; Brent A Senior; Adam M Zanation; Charles S Ebert; Adam J Kimple; Brian D Thorp; Dennis O Frank-Ito; Guilherme J M Garcia; Julia S Kimbell Journal: Sci Rep Date: 2020-06-29 Impact factor: 4.379