Evidence map›Paper›PMID 21674264›Full record

ArticlePharmaceutical research2011

Development and in vitro-in vivo evaluation of fenretinide-loaded oral mucoadhesive patches for site-specific chemoprevention of oral cancer.

Kashappa-Goud H Desai, Susan R Mallery, Andrew S Holpuch, Steven P Schwendeman

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Pharmaceutical research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07149220 (Safety and Chemopreventive Efficacy of Fenretinide Mucoadhesive System in Subjects With Premalignant Oral Intraepithelial Neoplasia), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT07149220 phase1active not recruitingnot on this mapstarted 2025, after this paper: background citation

Safety and Chemopreventive Efficacy of Fenretinide Mucoadhesive System in Subjects With Premalignant Oral Intraepithelial Neoplasia (OIN) Lesions: In Conjunction With Pharmacokinetic Assessment in Healthy Subjects.

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2025 to 2026Enrolled25ConditionsOral Leukoplakia, Oral DysplasiaArmsMucoadhesive fenretinide-releasing system (FMS)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 57 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Development andOncology letters · 2018
    Article
  8. Article
  9. Mucoadhesive formulation ofToxicology reports · 2015
    Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
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

4 authors at 3 institutions in 1 country.

Kashappa-Goud H DesaiDepartment of Pharmaceutical Sciences, University of Michigan, 428 Church St., Ann Arbor, Michigan, USA.
Susan R Mallery
Andrew S Holpuch
Steven P Schwendeman
University of Michigan–Ann Arbor · USThe Ohio State University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · US

Funding

University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
Chemoprevention of Head & Neck Cancer Using Controlled Release PolymersR01CA129609 · NCI · OHIO STATE UNIVERSITY · PI MALLERY, SUSAN R · 2009 to 2013
$1.5M
Chemopreventive Effects of Black Raspberries and Fenretinide in Oral MucosaF30DE020992 · NIDCR · OHIO STATE UNIVERSITY · PI HOLPUCH, ANDREW STEPHEN · 2010 to 2014
$164k
NCI NIH HHS R01 CA129609NCRR NIH HHS UL1 RR025755NCRR NIH HHS UL1RR025755NIDCR NIH HHS F30 DE020992
6 · The paper itself

Abstract

purposeTo develop fenretinide oral mucoadhesive patch formulations and evaluate their in vitro and in vivo release performance for future site-specific chemoprevention of oral cancer.

methodsSolubilization of fenretinide in simulated saliva (SS) was studied by incorporating nonionic surfactants (Tween® 20 and 80, and Brij® 35 and 98), bile salts (sodium salt of cholic, taurocholic, glycocholic, and deoxycholic acids), phospholipid (lecithin), and novel polymeric solubilizer (Souplus®). Adhesive (polycarbophil: hydroxypropyl methylcellulose 4KM) and drug release (Fenretinide/Eudragit® RL PO with or without solubilizers) layers were prepared by solvent casting. Oral mucoadhesive patches were formed by attaching drug and adhesive layers onto backing layer (Tegaderm™ film). Physical state of drug in Eudragit® films was examined by X-ray diffraction (XRD). Evaluation of in vitro and in vivo fenretinide release from the patch was conducted in SS containing 5%w/v sodium deoxycholate and rabbits, respectively. Fenretinide was quantified by HPLC.

resultsTween® 20 and 80, Brij® 98, and sodium deoxycholate exhibited the highest fenretinide solubilization potential among the solubilizers. Drug loading efficiency in Eudragit® films was 90%-97%. XRD suggested fenretinide was amorphous in solubilizer-free and solubilizer-loaded films. Solubilizer-free patch exhibited poor in vitro and in vivo controlled drug release behavior. Increases in drug loading (5-10 wt%) or changes in polymeric matrix permeability did not provide continuous drug release. Co-incorporation of either single or mixed solubilizers in fenretinide/Eudragit® patches, (20 wt% Tween® 20, Tween® 80 and sodium deoxycholate or 20 wt% Tween® 80 + 40 wt% sodium deoxycholate solubilizers) led to significantly improved continuous in vitro/in vivo fenretinide release.

conclusionFenretinide/Eudragit® RL PO patches with 20 wt% Tween® 80 + 40 wt% sodium deoxycholate solubilizers exhibit excellent release behavior for further preclinical and/or clinical evaluation in oral cancer chemoprevention.

Indexed as

AdhesivesAdministration, BuccalAnimalsBile Acids and SaltsChemopreventionDosage FormsDrug DesignFemaleFenretinideMouth MucosaMouth NeoplasmsPhospholipidsPolymersRabbitsSalivaSolubilityAdhesivesBile Acids and SaltsDosage FormsFenretinidePhospholipidsPolymersSurface-Active Agents

Identifiers

PMID21674264
PMCPMC3171589
OpenAlexW1986430333

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Registered trials

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.