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Pharmaceutics 2014, 6(2), 195-219;

Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

Department of Pharmaceutics and Biopharmaceutics, Kiel University, Grasweg 9a, 24118 Kiel, Germany
Janssen Pharmaceuticals, Pharmaceutical Development & Manufacturing Sciences, Johnson & Johnson, Hochstrasse 201, 8205 Schaffhausen, Switzerland
Author to whom correspondence should be addressed.
Received: 20 December 2013 / Revised: 24 March 2014 / Accepted: 31 March 2014 / Published: 11 April 2014
(This article belongs to the Special Issue Respiratory and Nasal Drug Delivery)
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Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results. View Full-Text
Keywords: nasal drug delivery; regulatory aspects; test methods; nasal sprays nasal drug delivery; regulatory aspects; test methods; nasal sprays

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This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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Trows, S.; Wuchner, K.; Spycher, R.; Steckel, H. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.. Pharmaceutics 2014, 6, 195-219.

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