Trial reportThe AAPS journal2021
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?
Erratum issuedOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph
Trial report in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.
0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
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.
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.
Who cites it
10 citing papers in PubMed, 19 citations in OpenAlex.
- Relative Bioavailability of Inhaled Fluticasone Propionate and Salmeterol - is Population Pharmacokinetic Modelling a Relevant Alternative to a Non-Compartmental Approach?Drug design, development and therapy · 2025Trial
- Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.Pharmaceutical research · 2025Review
- Mechanistic Physiologically Based Pharmacokinetic Modeling of Dry Powder and Nebulized Formulations of Orally Inhaled TMEM16A Potentiator GDC-6988.CPT: pharmacometrics & systems pharmacology · 2025Article
- iBCS: 4. Application of the Inhalation Biopharmaceutics Classification System to the Development of Orally Inhaled Drug Products.Molecular pharmaceutics · 2025Review
- Central and peripheral lung deposition of fluticasone propionate dry powder inhaler formulations in humans characterized by population pharmacokinetics.Pharmaceutical research · 2023Article
- Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.CPT: pharmacometrics & systems pharmacology · 2023Review
- Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development.Pharmaceutics · 2022Review
- Effect of MDI Actuation Timing on Inhalation Dosimetry in a Human Respiratory Tract Model.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Optimization of the TranswellPharmaceutics · 2021Article
- Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process.Pharmaceutics · 2021Review
Corrections and comments
- Erratum issued
Authors and funding
28 authors at 6 institutions in 2 countries.
Günther HochhausDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA. hochhaus@ufl.edu.
Mong-Jen ChenDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Abhinav KurumaddaliDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Uta SchillingDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Yuanyuan JiaoDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA.
Stefanie K DrescherDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Elham AminiDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Simon M BergerDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Bhargava KandalaDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Christine TabulovDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Jie ShaoDepartment of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida, 32610, USA.
Brandon SeayDivision of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida, USA.
Mutasim N Abu-HasanDivision of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida, USA.
Sandra M BaumsteinDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA.
Lawrence WinnerDepartment of Statistics, College of Liberal Arts & Sciences, University of Florida, Gainesville, Florida, USA.
Jagdeep ShurDepartment of Pharmacy & Pharmacology, Centre for Therapeutic Innovation, University of Bath, Bath, UK.
Robert PriceDepartment of Pharmacy & Pharmacology, Centre for Therapeutic Innovation, University of Bath, Bath, UK.
Michael HindleDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.
Xiangyin WeiDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, Virginia, USA.
Cynthia CarrascoWorldwide Clinical Trials, Austin, Texas, USA.
Dennis SandellS5 Consulting, Blentarp, Sweden.
Oluwamurewa OguntimeinOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Minori KinjoOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Renishkumar DelvadiaOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Bhawana SalujaOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Sau L LeeOffice of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Denise S ContiOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jürgen B BulittaDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Gainesville, Florida, 32827-7445, USA. jbulitta@cop.ufl.edu.
University of Florida · USCenter for Drug Evaluation and Research · USUniversity of Bath · GBVirginia Commonwealth University · USAbbVie (United States) · USWorldwide Clinical Trials (United States) · US
Funding
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2MDevelopment of Clinically Relevant in Vitro Performance Test for Generic OIDPsU01FD005231 · FDA · VIRGINIA COMMONWEALTH UNIVERSITY · PI HINDLE, MICHAEL · 2014 to 2016
$583kAn Optimized Dissolution Test System for Orally Inhaled Drugs: Development and VaU01FD004950 · FDA · UNIVERSITY OF FLORIDA · PI HOCHHAUS, GUENTHER · 2013 to 2014
$245kFDA HHS U01 FD004950FDA HHS U01 FD005231NCATS NIH HHS UL1 TR001427
Abstract
In the context of streamlining generic approval, this study assessed whether pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products (OIDPs). Three fluticasone propionate (FP) dry powder inhaler (DPI) formulations (A-4.5, B-3.8, and C-3.7), differing only in type and composition of lactose fines, exhibited median mass aerodynamic diameter (MMAD) of 4.5 μm (A-4.5), 3.8 μm (B-3.8), and 3.7 μm (C-3.7) and varied in dissolution rates (A-4.5 slower than B-3.8 and C-3.7). In vitro total lung dose (TLD
Indexed as
Administration, InhalationAdolescentAdultAerosolsArea Under CurveBronchodilator AgentsCross-Over StudiesDouble-Blind MethodDrug LiberationDrugs, GenericDry Powder InhalersFemaleFluticasoneHealthy VolunteersHumansMaleAerosolsBronchodilator AgentsDrugs, GenericFluticasonePowdersbioequivalence of generic inhaled drugsdry powder inhalersfluticasone propionatepharmacokineticsregional lung deposition
Identifiers
What OpenQuestion holds
Textmetadata
LicenceTDM
Read underepoch 390
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.