Regulatory Aspects of Nasal and Pulmonary Spray Drug Products

Farina, Dino

doi:10.1016/b978-0-8155-2025-2.10010-1

Cited by 5 publications

(8 citation statements)

References 20 publications

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“…Laser diffraction is a fast and efficient method that measures the geometric size of droplets and particles in real-time based on two common light scattering principles, which are Mie- or Fraunhofer-theory [19,21]. When determining the DSD, time-resolved measurements should be performed, i.e.…”

Section: Resultsmentioning

confidence: 99%

“…In order to determine the DSD of a nasal spray, the FDA and the EMA [ 8 , 9 , 11 ] recommend making use of laser diffraction, which has already become the standard technique in the industry for droplet and particle size analysis [ 4 ]. Laser diffraction is a fast and efficient method that measures the geometric size of droplets and particles in real-time based on two common light scattering principles, which are Mie- or Fraunhofer-theory [ 19 , 21 ]. When determining the DSD, time-resolved measurements should be performed, i.e.…”

Section: Resultsmentioning

confidence: 99%

“…For in vitro equivalence purposes, the FDA recommends determining the time history profiles of droplet sizes and obscuration over the complete life of the single spray at two distances ranging from 2 to 7 cm from the nozzle tip, with the two distances separated by 3 cm or more [ 9 ]. For new drug applications (NDAs), only one distance within this range is requested [ 8 , 21 ]. In both cases, the data to report should be collected only during the fully developed phase and should comprise the droplet size expressed as D 10 , D 50 and D 90 , as well as the span defined as ( D 90 − D 10 )/ D 50 as an indicator for the width of the distribution and, for NDAs, additionally, the fraction of droplets smaller than 10 µm [ 8 , 9 ].…”

Section: Resultsmentioning

confidence: 99%

“…The determination of shot weights serves to check the functionality of the valve and to assess pump-to-pump reproducibility in terms of drug product performance to assure reproducible and precise dosing [ 8 , 21 ]. In order to determine shot weights for a nasal spray, the device should be weighed prior and after each actuation on an analytical balance to assess the emitted mass.…”

Section: Resultsmentioning

confidence: 99%

“…Generally, the correct performance of the valve should be ensured primarily by the pump manufacturer, who is, in most cases, responsible for the assembly of the nasal spray pump [ 21 ]. However, the FDA recommends verifying the pump delivery.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2014

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

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

et al. 2014

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Toward a Radically Simple Multi‐Modal Nasal Spray for Preventing Respiratory Infections

Joseph,

Baby,

Quintero

et al. 2024

Advanced Materials

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Nasal sprays for pre‐exposure prophylaxis against respiratory infections show limited protection (20–70%), largely due to their single mechanism of action—either neutralizing pathogens or blocking their entry at the nasal lining, and a failure to maximize the capture of respiratory droplets, allowing them to potentially rebound and reach deeper airways. This report introduces the Pathogen Capture and Neutralizing Spray (PCANS), which utilizes a multi‐modal approach to enhance efficacy. PCANS coats the nasal cavity, capturing large respiratory droplets from the air, and serving as a physical barrier against a broad spectrum of viruses and bacteria, while rapidly neutralizing them with over 99.99% effectiveness. The formulation consists of excipients identified from the FDA's Inactive Ingredient Database and Generally Recognized as Safe list to maximize efficacy for each step in the multi‐modal approach. PCANS demonstrates nasal retention for up to 8 hours in mice. In a severe Influenza A mouse model, a single pre‐exposure dose of PCANS leads to a >99.99% reduction in lung viral titer and ensures 100% survival, compared to 0% in the control group. PCANS suppresses pathological manifestations and offers protection for at least 4 hours. This data suggest PCANS as a promising daily‐use prophylactic against respiratory infections.

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