FDA Guidance to Industry for Nasal Spray Products

In April 2003 the US Food and Drug Administration’s (FDA's) Centre for Drug Evaluation and Research (CDER) published a draft “Guidance for Industry” document entitled Bioavailability (BA) and Bioequivalence (BE) Studies for Nasal Aerosols and Nasal Sprays for Local Action.

This guidance document outlines the testing that may be carried out in order to assess drug bioavailability during nasal product quality studies in support of new drug applications (NDAs) or abbreviated new drug applications (ANDAs). Within the guidance there is a reliance on the use of comparative in vitro tests in order to determine bioequivalence. Laser diffraction is recommended for the assessment of the droplet size produced by each pump. In addition, the use of automated actuation stations to eliminate user bias is recommended.

The Spraytec system offers users a means of following the FDA’s guidance by providing:

• Rapid Data Acquisition: Measurement acquisition rates of 2.5kHz and beyond allow the changes in particle size observed during single device actuations to be followed, allowing each phase of atomisation (referred to as the “Formation”, “Fully Developed” and “Dissipation” phases) to be identified in accordance with the FDA’s guidance.
• Flexible Data Analysis: The averaging functions within the Spraytec software enables automatic calculation of the average droplet size delivered during each phase of atomization during pump actuation.
• Measurement Reproducibility: During SOP definition, users can opt to measure three repeat actuations of a given nasal spray device. The software will then automatically calculate the average particle size delivered during the Stable phase for each actuation, allowing the pump reproducibility to be assessed.
• Device Positioning: The Spraytec NSS accessory allows users to accurately position the nasal spray pump relative to the measurement zone, enabling users to carry out testing at different distances, as required by the draft guidance.
• Validated Performance: Full IQ/OQ support is provided for both the actuator system and the Spraytec.

In addition to supporting bioequivalence studies, the Spraytec system also provides a possible means of carrying out the testing recommended by the FDA within its Chemistry, Manufacturing and Controls (CMC) draft guidance for Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products, including understanding how the orientation of the pump affects the delivered droplet size.

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