Evidence map›Paper›PMID 32702372›Full record

ArticleJournal of pharmaceutical sciences2020

Evaluation of Heat Effects on Fentanyl Transdermal Delivery Systems Using In Vitro Permeation and In Vitro Release Methods.

Qian Zhang, Michael Murawsky, Terri D LaCount, Jinsong Hao, Priyanka Ghosh, Sam G Raney, Gerald B Kasting, S Kevin Li

Open access · greenAbstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 46% of its field
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

7 citing papers in PubMed, 14 citations in OpenAlex.

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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

8 authors at 3 institutions in 1 country.

Qian ZhangDivision of Pharmaceutical Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267, USA.
Michael MurawskyDivision of Pharmaceutical Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267, USA.
Terri D LaCountDivision of Pharmaceutical Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267, USA.
Jinsong HaoDepartment of Pharmaceutical Science and Research, School of Pharmacy, Marshall University, Huntington, WV 25755, USA; Department of Pharmaceutical Sciences, College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC 27506, USA.
Priyanka GhoshDivision of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Sam G RaneyDivision of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Gerald B KastingDivision of Pharmaceutical Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267, USA.
S Kevin LiDivision of Pharmaceutical Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267, USA. Electronic address: kevin.li@uc.edu.
University of Cincinnati Medical Center · USUnited States Food and Drug Administration · USMarshall University · US

Funding

Tiered Testing Strategy for Assessing Thermal Effects on Transdermal ProductsU01FD004942 · FDA · UNIVERSITY OF CINCINNATI · PI LI, KEVIN S. · 2013 to 2015
$994k
FDA HHS U01 FD004942
6 · The paper itself

Abstract

Experimental conditions that could impact the evaluation of heat effects on transdermal delivery systems (TDS) using an in vitro permeation test (IVPT) and in vitro release testing (IVRT) were examined. Fentanyl was the model TDS. IVPT was performed using Franz diffusion cell, heating lamp, and human skin with seven heat application regimens. IVRT setup was similar to IVPT, without using skin. Dissolution study was conducted in a modified dissolution chamber. The activation energy of skin permeation for fentanyl was determined using aqueous solution of fentanyl. In IVPT, the increase of temperature from 32 °C to 42 °C resulted in a 2-fold increase in flux for fentanyl TDS, consistent with the activation energy determined. The magnitude of flux increase was affected by the heat exposure onset time and duration: higher flux was observed when heat was applied earlier or following sustained heat application. Heat induced flux increases could not be observed when inadequate sampling time points were used, suggesting the importance of optimizing sampling time points. Drug release from TDS evaluated using IVRT was fast and the skin was the rate-limiting barrier for TDS fentanyl delivery under elevated temperature.

Indexed as

FentanylSkin AbsorptionAdministration, CutaneousDrug Delivery SystemsHot TemperatureHumansPermeabilitySkinFentanylFentanylHeat effectIn vitro drug release testing (IVRT)In vitro permeation test (IVPT)Skin permeationTransdermalTransdermal delivery system (TDS)Transport activation energy

Identifiers

PMID32702372
PMCPMC7644256
OpenAlexW3043327899

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.