Evidence map›Paper›PMID 41579635›Full record

ArticleJournal of pharmaceutical and biomedical analysis2026

Biopharmaceutical assessment of naloxone permeation through human respiratory epithelial tissues: A chromatographic-mass spectrometric approach with cloud based aerosol dosing and delivery.

Tasmin Ara Sultana, Diaa Shakleya, Dustin G Brown, Patrick J Faustino, Muhammad Ashraf, Ahmed Zidan

Abstract read
In one paragraph

Article in Journal of pharmaceutical and biomedical analysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Tasmin Ara SultanaOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA.
Diaa ShakleyaOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA.
Dustin G BrownOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA.
Patrick J FaustinoOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA.
Muhammad AshrafOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA.
Ahmed ZidanOffice of Pharmaceutical Quality Research, OPQ, CDER, US. FDA, USA. Electronic address: ahmed.zidan@fda.hhs.gov.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Understanding naloxone permeation is important for optimizing nasal delivery and supporting comparative assessment of nasal drug products. In this study, a stability-indicating LC-MS/MS method was developed and validated for the simultaneous quantification of naloxone and its related impurities, naloxone N-oxide and noroxymorphone, in in vitro permeation test receptor media. The validated method was applied to characterize naloxone permeation following cloud-based aerosol dosing across a synthetic Nuclepore Track-Etched membrane and a differentiated human EpiAirway™ mucociliary tissue model under finite-dose conditions. The analytical procedure demonstrated linearity over 0.25-20.0 ng/mL in Dulbecco's Phosphate-Buffered Saline and Krebs-Ringer Bicarbonate Buffer, with acceptable accuracy and precision. No degradation products or additional impurities were detected in permeation samples, confirming the stability-indicating capability of the method. Naloxone exhibited rapid early-time permeation across the synthetic membrane, whereas transport across the epithelial tissue model was attenuated and plateaued, reflecting physiological barrier function. Integration of cloud-based aerosol delivery with a validated LC-MS/MS platform enables mechanistic evaluation of nasal naloxone permeation and provides a supportive in vitro framework for formulation characterization and comparative assessments.

Indexed as

NaloxoneNarcotic AntagonistsRespiratory MucosaAdministration, IntranasalAerosolsChromatography, LiquidDrug Delivery SystemsHumansLiquid Chromatography-Mass SpectrometryPermeabilityReproducibility of ResultsTandem Mass SpectrometryAerosolsNaloxoneNarcotic AntagonistsAerosol drug deliveryEpiAirway™ modelIn vitro permeation testLC–MS/MSNaloxoneNasal drug productsSynthetic membranes

Identifiers

PMID41579635
PMCPMC12958147

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.