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Effect of Formulation- and Administration-Related Variables on Deposition Pattern of Nasal Spray Pumps Evaluated Using a Nasal Cast

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ABSTRACT

Purpose

To systematically evaluate the effect of formulation- and administration-related variables on nasal spray deposition using a nasal cast.

Methods

Deposition pattern was assessed by uniformly coating a transparent nose model with Sar-Gel®, which changes from white to purple on contact with water. Sprays were subsequently discharged into the cast, which was then digitally photographed. Images were quantified using Adobe® Photoshop. The effects of formulation viscosity (which influences droplet size), simulated administration techniques (head orientation, spray administration angle, spray nozzle insertion depth), spray pump design and metering volume on nasal deposition pattern were investigated.

Results

There was a significant decrease in the deposition area associated with sprays of increasing viscosity. This appeared to be mediated by an increase in droplet size and a narrowing of the spray plume. Administration techniques and nasal spray pump design also had a significant effect on the deposition pattern.

Conclusions

This simple color-based method provides quantitative estimates of the effects that different formulation and administration variables may have on the nasal deposition area, and provides a rational basis on which manufacturers of nasal sprays can base their patient instructions or post approval changes when it is impractical to optimize these using a clinical study.

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REFERENCES

  1. Arora P, Sharma S, Garg S. Permeability issues in nasal drug delivery. Drug Discov Today. 2002;7(18):967–75.

    Article  PubMed  CAS  Google Scholar 

  2. Suman JD, Laube BL, Dalby R. Comparison of nasal deposition and clearance of aerosol generated by nebulizer and an aqueous spray pump. Pharm Res. 1999;16(10):1648–52.

    Article  PubMed  CAS  Google Scholar 

  3. Newman SP, Steed KP, Hardy JG, Wilding IR, Hooper G, Sparrow RA. The distribution of an intranasal insulin formulation in healthy volunteers: effect of different administration techniques. J Pharm Pharmacol. 1994;46:657–60.

    Article  PubMed  CAS  Google Scholar 

  4. Vidgren MT, Kublik H. Nasal delivery systems and their effect on deposition and absorption. Adv Drug Deliv Rev. 1998;29:157–77.

    Article  PubMed  Google Scholar 

  5. Food Drug Administration. U.S. FDA draft guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. Rockville: US Food and Drug Administration; 2003.

    Google Scholar 

  6. Harris AS, Svensson E, Wagner ZG, Lethagen S, Nilsson IM. Effect of viscosity on particle size, deposition, and clearance of nasal delivery systems containing desmopressin. J Pharm Sci. 1988;77:405–8.

    Article  PubMed  CAS  Google Scholar 

  7. Cheng YS, Holmes TD, Gao J, Guilmette RA, Li S, Surakitbanharn Y, et al. Characterization of nasal spray pumps and deposition pattern in a replica of the human nasal airway. J Aerosol Med. 2001;14:267–80.

    Article  PubMed  CAS  Google Scholar 

  8. Foo MY, Cheng Y, Su W, Donovan MD. The influence of spray properties on intranasal deposition. J Aerosol Med. 2007;20(4):495–508.

    Article  PubMed  CAS  Google Scholar 

  9. Kimbell JS, Segal RA, Asgharian B, Wong BA, Schroeter JD, Southhall JP, et al. Characterization of deposition from nasal spray devices using a computational fluid dynamics model of the human nasal passages. J Aerosol Med. 2007;20:59–74.

    Article  PubMed  Google Scholar 

  10. Kundoor V, Dalby RN. Assessment of nasal spray deposition in a silicone human nose model using a color based method. Pharm Res. 2010;27(1):30–6.

    Article  PubMed  CAS  Google Scholar 

  11. Poochikian G, Shah V. Pharmaceutical quality assessment system (PQAS): science and risk managed approaches for inhalation drug products. In: Dalby RN, Byron PR, Peart J, Suman JD, editors. Respiratory Drug Delivery 2006 (Book 1, ISBN 1-930114-95-8). Davis Healthcare, River Grove: Illinois; 2006;151–8.

  12. Pharmaceutical cGMPS for the 21st century—a risk-based approach. Rockville: US Food and Drug Administration; 2004.

  13. Doughty DV, Vibbert C, Bollinger ME, Kewalramani A, Dalby RN. Automated Actuation of Nasal Spray Products: Determination and Comparison of Adult and Pediatric Settings. Drug Dev Ind Pharm. 2010;37(3):359–366.

    Google Scholar 

  14. Benninger MS, Hadley JA, Osguthorpe JD, Marple BF, Leopold DA, Derebery MJ, et al. Techniques of intranasal steroid use. Otolaryngol Head Neck Surg. 2004;130:5–24.

    Article  PubMed  Google Scholar 

  15. Guo Y, Laube B, Dalby R. The effect of formulation variables and breathing patterns on the site of nasal deposition in an anatomically correct model. Pharm Res. 2005;22(11):1871–8.

    Article  PubMed  CAS  Google Scholar 

  16. Pennington J, Pandey P, Tat H, Willson J, Donovan B. Spray pattern and droplet size analyses for high-shear viscosity determination of aqueous suspension corticosteroid nasal sprays. Drug Dev Ind Pharm. 2008;34:923–9.

    Article  PubMed  CAS  Google Scholar 

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Author notes

  1. Vipra Kundoor

    Present address: U.S Food & Drug Administration, 7520 Standish Place, Rockville, Maryland, USA

Authors and Affiliations

  1. Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Baltimore, Maryland, USA

    Vipra Kundoor & Richard N. Dalby

Authors
  1. Vipra Kundoor
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  2. Richard N. Dalby
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Correspondence to Vipra Kundoor.

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Kundoor, V., Dalby, R.N. Effect of Formulation- and Administration-Related Variables on Deposition Pattern of Nasal Spray Pumps Evaluated Using a Nasal Cast. Pharm Res 28, 1895–1904 (2011). https://doi.org/10.1007/s11095-011-0417-6

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  • DOI: https://doi.org/10.1007/s11095-011-0417-6

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