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Scientific study examining experimental setups and analytical considerations for measuring the inhalable fraction of droplets smaller than 10 micron in nasal pharmaceutical products.
Field:
Pharmaceutics and Biopharmaceutics
Topic:
Nasal drug delivery and aerosol particle size assessment
Type of document:
Scientific research article
Authors:
Niklas Baltz; Regina Scherließ
Affiliation:
Department of Pharmaceutics and Biopharmaceutics, Kiel University
Institution:
Kiel University
City:
Kiel
Country:
Germany
Research focus:
Determination of inhalable mass fraction below 10 micron in nasal spray formulations
Studied formulations:
Commercial nasal spray for allergy treatment
Analytical methods discussed:
Impactor analysis; HPLC with UV-Vis detection; comparison with laser diffraction
Tested equipment:
Fast Screening Impactor (FSI); Next Generation Impactor (NGI); reduced NGI (rNGI)
Regulatory context:
EMA and FDA recommendations on nasal product development
Measured parameter:
Mass fraction of droplets or particles less than 10 micron
Application context:
Safety evaluation of intranasal drug administration and potential pulmonary exposure
Related therapeutic area:
Intranasal treatments including therapies targeting the central nervous system
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Type of study:
Clinical data analysis
Study focus:
B cell and macrophage interactions in patient outcomes
Patient group:
Diagnosed patients undergoing chemotherapy
Variables analyzed:
Age at diagnosis, treatment type, surgical outcome
Endpoints:
Hazard ratios, confidence intervals, p-values
Data source:
Supplementary material from research study
Measurement thresholds:
20 Micron, 30 Micron
Statistical methods:
Survival analysis, hazard ratios
Population size:
Not specified
Contextual description:
Supplementary table from a clinical study presenting hazard ratios and confidence intervals for patient characteristics and treatment effects at two microscopic thresholds.
Year:
Not specified
Region / City:
Not specified
Topic:
Automotive repair
Document Type:
Instruction manual
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Yamaha Viper or Sidewinder owners
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Subject Area:
Math
Grade Level:
4th Grade
Standards:
CCSS.4NF.1, CCSS.4NF.4a, CCSS.4NF.4c
Objective:
Add and subtract fractions, order fractions, design and read line plots, find equivalent fractions, multiply fractions with whole numbers, solve multiplication story problems.
Type:
Lesson Plan
Audience:
4th grade students
Duration:
1 hour
Stations:
4
Materials:
Dice, Stopwatch, Pencils, Solo cups, Worksheets, Clipboards, Cards, Hovercam
Learning Styles:
Interpersonal, Intrapersonal, Mathematical/Logical, Bodily/Kinesthetic
Engagement Methods:
Group work, peer teaching, hands-on activities, and movement
Assessment:
Paper/worksheet collection, credit or no credit
Reflection:
N/A
Year:
2016
Region / City:
N/A
Subject:
Math
Document Type:
Homework Assignment
Author:
Mrs. S, Ms. Church, Ms. Volpe
Target Audience:
6th Grade Students
Period of Validity:
June 13–17, 2016
Approval Date:
N/A
Modification Date:
N/A
Year:
2021
Region / City:
Italy, Sweden
Topic:
Heart failure, medical therapy, clinical guidelines
Document Type:
Research article
Organization / Institution:
Institute of Cardiology, ASST Spedali Civili, University of Brescia, Karolinska Institutet, Humanitas Research Hospital IRCCS, University of Trieste, IRCCS San Raffaele, etc.
Authors:
Daniela Tomasoni, Matteo Pagnesi, Giada Colombo, Mauro Chiarito, Davide Stolfo, Luca Baldetti, Carlo Mario Lombardi, Marianna Adamo, Giuseppe Maggi, Riccardo Maria Inciardi, Ferdinando Loiacono, Marta Maccallini, Alessandro Villaschi, Gaia Gasparini, Marco Montella, Stefano Contessi, Daniele Cocianni, Maria Perotto, Giuseppe Barone, Marco Merlo, Alberto Maria Cappelletti, Giuseppe Rosano, Gianfranco Sinagra, Daniela Pini, Gianluigi Savarese, Marco Metra
Target Audience:
Medical professionals, researchers, healthcare institutions
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
United Kingdom
Topic:
Heart failure, Myocardial fibrosis, Pirfenidone
Document Type:
Clinical Trial Report
Organization / Institution:
University of Manchester, University of Liverpool, University of Pittsburgh, NHS Trusts
Authors:
Gavin A. Lewis, Susanna Dodd, Dannii Clayton, Emma Bedson, Helen Eccleson, Erik B. Schelbert, Josephine H. Naish, Beatriz Duran Jimenez, Simon G. Williams, Colin Cunnington, Fozia Zahir Ahmed, Anne Cooper, Rajavarma Viswesvaraiah, Stuart Russell, Theresa McDonagh, Paula R. Williamson, Christopher A. Miller
Target Audience:
Cardiologists, Medical researchers, Healthcare professionals
Period of Action:
March 7, 2017 - December 19, 2018
Date of Approval:
2021
Date of Changes:
N/A
Context:
Randomized, double-blind phase 2 trial assessing the efficacy and safety of pirfenidone in patients with heart failure with preserved ejection fraction (HFpEF) and myocardial fibrosis.
Year:
2023
Region / City:
Valencia, Spain; Kgs. Lyngby, Denmark
Subject:
Phosphorus recovery, hydrothermal carbonization, municipal solid waste
Document type:
Research article
Institution:
Ingelia, S.L.; Technical University of Denmark; Instituto de Tecnología Química (UPV-CSIC)
Authors:
Borja Oliver-Tomas, Martin Hitzl, Mikołaj Owsianiak, Michael Renz
Target audience:
Environmental scientists, waste management professionals
Methods:
Hydrothermal carbonization, mineral acid extraction, life cycle assessment
Key findings:
Nitric acid most efficient for phosphorus extraction; separate use of hydrochar and phosphorus increases environmental impact
Applications:
Fertilizer production, solid fuel utilization
Keywords:
Advanced hydrochar, low-ash solid fuel, phosphorus extraction, phosphorus fertilizer
Subject:
Mathematics
Topic:
Fraction comparison and reasoning
Document type:
Worksheet answer key
Educational level:
Elementary school
Task format:
Comparison of fractions with visual or verbal justification
Number of exercises:
44
Response format:
Picture explanation or written reasoning
Content elements:
Fraction pairs, inequality symbols, sample explanations
Year:
N/A
Region / City:
N/A
Theme:
Mathematics
Document Type:
Educational Text
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Students
Effective Date:
N/A
Date of Changes:
N/A
Context:
This document provides step-by-step solutions for mathematical problems, including improper fractions, number representation, and word problems, aimed at educating learners in basic arithmetic and number theory.
Year:
2026
Region / City:
North Carolina, USA
Subject:
Mathematics
Document Type:
Lesson Plan
Institution:
North Carolina Department of Public Instruction
Author:
Trisha Speed Shaskan (book), adapted by classroom teacher
Target Audience:
Third grade students
Standards:
NC.3.NF.1, NC.3.NF.2, Standards for Mathematical Practice 2,3,4,8
Materials:
Paper, pencils, book “If You Were a Fraction”
Preparation:
Read the book and prepare activity sheets
Lesson Duration:
30-45 minutes
Activities:
Reading, identifying fractions in classroom, discussion, exit ticket evaluation
Year:
2024
Region / City:
United States
Topic:
Medical Appeal Letter
Document Type:
Template
Organization / Institution:
OptiNose, Inc.
Author:
OptiNose, Inc.
Target Audience:
Healthcare providers, medical professionals
Period of Validity:
Indefinite
Approval Date:
05/2024
Date of Changes:
None
Year:
2025
Region / city:
United Kingdom
Topic:
Immunization, Influenza Vaccine
Document Type:
Addendum
Organization / Institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Alex Allen, Greta Hayward
Target Audience:
Health professionals, Immunization Programs
Effective Period:
1 September 2025 - 1 April 2026
Approval Date:
6 August 2025
Modification Date:
23 July 2025
Background:
Live attenuated influenza vaccine nasal spray suspension (Fluenz®) updated formula
Contextual Description:
Addendum to UKHSA PGD v15.0 detailing updates to the influenza vaccine composition and active strains.
Year:
2025
Region / city:
England
Topic:
Influenza Vaccination
Document Type:
Patient Group Direction (PGD)
Authority / institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Jamie Lopez-Bernal, Greta Hayward
Target Audience:
Healthcare practitioners, immunisation staff
Period of validity:
From 1 September 2025 to 1 April 2026
Approval Date:
1 July 2025
Amendment Date:
25 June 2025
Year:
2024
Region / City:
EMEA
Therapeutic Area:
Allergic rhinitis
Document Type:
Product Information
Organization / Institution:
European Medicines Agency
Author:
Not specified
Target Audience:
Healthcare professionals
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2024-2025
Region / City:
Washington State
Topic:
Medical authorization form
Document Type:
Medical Authorization
Organization:
Washington State School for the Blind
Author:
Licensed Health Professional
Target Audience:
Parents/Guardians, School Staff
Effective Period:
07/01/2024 - 08/31/2025
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Note:
Region / city
Topic:
Nasal valve collapse, radiofrequency treatment
Document type:
Medical Procedure Description
Organization / institution:
HERC
Target audience:
Medical professionals
Approval date:
November 2022
Contextual description:
A medical document outlining the procedure code 30469 for repairing nasal valve collapse using low-energy, temperature-controlled radiofrequency treatment, detailing evidence and payer policies.
Authors:
Ruixin Zhou; Carolyn Jordan; Justin Lygrisse; Adrian Raiche
Organization:
Kindeva Drug Delivery, Lexington, KY, USA
Address:
1513 Bull Lea Road, Lexington, KY 40511, USA
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Regulatory Document Referenced:
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation (July 2002)
Drug Product:
RezenopyTM
Dosage Form:
Nasal spray drug product
Study Type:
Comparative spray characterization and statistical equivalence study
Testing Parameters:
Spray pattern; Droplet size distribution (DV10, DV50, DV90, Span, %Volume < 10 µm); Delivered dose (% of label claim)
Media Compared:
USP Purified Water (USP-PW); Placebo formulation; Drug product formulation
Sample Size:
n=90 per test (30 samples per group)
Statistical Method:
Two-sample equivalence test; 95% confidence interval
Software Used:
Viota® Software; Minitab Statistical Software (version 22.1)
Equipment:
SprayVIEW® measurement system; Spraytec® system
Components Evaluated:
Incoming actuator (pump) lots; Finished combination product
Regulatory Context:
NDA filing; FDA-approved nasal spray product
Year:
2021
Region / City:
Hatfield, United Kingdom
Topic:
Computational Fluid Dynamics, Nasal Delivery Devices, Fluid Mechanics
Document Type:
Research Article
Institution:
University of Hertfordshire, University College London, Bespak
Authors:
Hessam Rasooli Nia, Darragh Murnane, Michael Cook, Adam Gibbons, Sabrina Falloon
Target Audience:
Researchers, Engineers, Pharmaceutical Scientists
Period of Effectiveness:
N/A
Approval Date:
N/A
Modification Date:
N/A
Title:
Supplement to “Broadening the Berlin Definition of ARDS to Patients Receiving High–flow Nasal Oxygen”
Study type:
Observational study
Document type:
Supplement including statistical analysis plan, tables and figures
Study population:
Patients with acute hypoxemic respiratory failure due to COVID–19
Clinical focus:
Acute respiratory distress syndrome according to the Berlin definition
Interventions compared:
High–flow nasal oxygen and invasive ventilation
Severity classification:
Mild, moderate and severe ARDS
Outcomes reported:
ICU discharge, hospital discharge, 28–day mortality, 90–day all–cause mortality
Statistical methods:
Hazard ratios with centre as random effect
Corresponding author:
Fleur–Stefanie L.I.M. van der Ven
Institution:
Department of Intensive Care, Amsterdam University Medical Centers, location ‘AMC’
Country:
The Netherlands
Collaborating group:
PRoAcT–COVID study investigators
Year:
2026
Region / City:
Nottingham, UK
Topic:
Nasal drug delivery, spray drying technology
Document type:
Research paper
Institution:
Upperton Pharma Solutions
Authors:
Lara C. Penn, Shailesh K. Mistry, Richard Johnson
Target Audience:
Pharmaceutical scientists, researchers in drug delivery systems
Date of approval:
2026
Date of amendments:
None