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

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Technologies
• Regulatory Science

Background:

• Spray pattern and plume geometry characterization for orally inhaled and nasal drug products (OINDP) have evolved over two decades.
• Technological advancements have occurred since the 1998 FDA draft guidance for Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs).

Purpose of the Study:

• To provide historical context and background on plume geometry and spray pattern characterization studies.
• To analyze the current regulatory landscape and industry practices for OINDP plume analysis.
• To offer insights to regulatory bodies and stakeholders through case studies and best practices.

Main Methods:

• Review of historical development of plume characterization techniques.
• Analysis of current regulatory context and industry survey data on testing value and application.
• Presentation of case studies and best practices in plume geometry and spray pattern assessment.

Main Results:

• Plume geometry and spray pattern characterization are valuable in OINDP development.
• Industry surveys indicate significant application and perceived value of these characterization techniques.
• Further data is required to fully understand the role of these techniques in assessing formulation characteristics.

Conclusions:

• Continued dialogue between industry and regulatory bodies is essential.
• Optimization of plume characterization techniques for OINDP development requires further investigation.
• Establishing optimal use of these techniques will enhance regulatory submissions and product quality.