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Review
. 2022 May 18;23(5):145.
doi: 10.1208/s12249-022-02278-w.

Spray Pattern and Plume Geometry Testing and Methodology: An IPAC-RS Working Group Overview

Sherryl Baxter  1 , Ben Myatt  2 , Stephen Stein  3 , Adrian Parkinson  4 , Frank Chambers  5 , Bill Doub  6 , Jernej Grmas  7 , Julie Suman  8 , Keith Miller  9 , Biswadip Sinha  10 , Linda Liao  11 , Ian Carter  12 , Dino Farina  11 , Segolene Sarrailh  13 , Manfred Fischer  14 , Declan Walsh  15 , Lee Nagao  16
Affiliations
Review

Spray Pattern and Plume Geometry Testing and Methodology: An IPAC-RS Working Group Overview

Sherryl Baxter et al. AAPS PharmSciTech. .

Abstract

Plume characterization for orally inhaled and nasal drug products (OINDP) provides valuable information during OINDP development. Spray pattern and plume geometry techniques, methods, and technology have evolved over the past 20 years since the publication of the original 1998 FDA MDI DPI draft guidance. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) discusses the historical context and background to plume geometry and spray pattern characterization studies; provides an analysis of the current regulatory context; addresses results from its industry surveys on application and value of such testing; and presents case studies and best practices-seeking to provide insights to regulatory bodies and other stakeholders. Assessment and consideration of published studies and industry experience note the value of plume geometry and spray pattern in development, and that further data is needed regarding their use in assessing formulation characteristics. Continued dialogue between industry and regulatory bodies is needed to establish the optimum use of these techniques.

Keywords: inhalation; nasal; plume geometry; spray pattern.

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References

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    1. ITFG/IPAC-RS. A response to the draft guidance for industry metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and controls documentation. ITFG/IPAC-RS Collaboration CMC Tests and Methods Technical Team; 2001. p. 34–45. Available from IPAC-RS: https://www.ipacrs.org/ . Accessed 22 Apr 2022.
    1. Chambers F, De S, Baxter S, Parkinson A, Doub WH, Breakwell I, et al. Plume geometry testing relevance and methodology: an IPAC-RS survey. Respiratory Drug Delivery. 2018;2018(2):437–42.
    1. Baxter S, Parkinson A, Myatt B, Sinha B, Doub B, De S, et al. Spray pattern testing relevance and methodology: an IPAC-RS survey. Estoril Portugal: RDD Europe; 2019.
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