Evidence map›Paper›PMID 30199502›Full record

ArticleOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2018

A Polymer-Based Extended Release System for Stable, Long-term Intracochlear Drug Delivery.

Erik Pierstorff, Shanshan Chen, Maria Paola Chaparro, John M Cortez, Yen-Jung Chen, Su Young Ryu, Sherry M Tsai, Marc M Baum, Wan Wan Yang, Federico Kalinec and 3 more

Abstract read
In one paragraph

Article in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Inner ear delivery: Challenges and opportunities.Laryngoscope investigative otolaryngology · 2020
    Review
  5. 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

13 authors.

Erik PierstorffO-Ray Pharma, Inc.
Shanshan ChenAuritec Pharmaceuticals, Inc., Pasadena.
Maria Paola ChaparroHouse Research Institute, House Ear Clinic.
John M CortezAuritec Pharmaceuticals, Inc., Pasadena.
Yen-Jung ChenHouse Research Institute, House Ear Clinic.
Su Young RyuOak Crest Institute of Science, Monrovia.
Sherry M TsaiOak Crest Institute of Science, Monrovia.
Marc M BaumOak Crest Institute of Science, Monrovia.
Wan Wan YangO-Ray Pharma, Inc.
Federico KalinecDepartment of Head and Neck Surgery, David Geffen School of Medicine at the University of California, Los Angeles, California.
Thomas SmithO-Ray Pharma, Inc.
Stacey LudwigAuritec Pharmaceuticals, Inc., Pasadena.
William H SlatteryO-Ray Pharma, Inc.

Funding

Sustained Release Inner Ear Delivery of CorticosteroidR44DC008477 · NIDCD · O-RAY PHARMA, INC. · PI PIERSTORFF, ERIK, SLATTERY, WILLIAM H · 2010 to 2015
$2.4M
NIDCD NIH HHS R44 DC008477
6 · The paper itself

Abstract

objectiveInvestigate a new polymer-based drug coating suitability for safe intracochlear delivery and ability to maintain long-term physiologically active levels of the corticosteroid fluticasone propionate. STUDY

designIn vitro dissolution study to evaluate release profiles of polymer-coated drug particles and in vivo studies using a guinea pig model to measure perilymph drug concentrations at specific time points after implantation with polymer-coated drug particles and evaluate their effect on hearing function.

methodsPolymer-coated fluticasone propionate (FP) particles were surgically implanted in guinea pigs through the round window membrane into the cochlear scala tympani. In the pilot study, pre- and post-op hearing thresholds were conducted on days 7, 14, and 42. In a second study, post-op hearing thresholds were conducted on days 90, 120, and 180. Perilymph drug concentrations were measured on the same time points.

resultsIn 15 of 16 animals from day 7 through day 90, drug levels were within the targeted range, with no initial burst release detected. Drug was present in all animals on day 90 and was detected in some animals at 120 and 180 days. Hearing was tested and compared with non-implanted ears. Very good hearing preservation was observed in ears implanted with intracochlear particles when compared with contralateral ears.

conclusionsThe polymer-based extended release system is effective in providing long-term, stable drug delivery for at least 90 days with good hearing outcomes. The results of this study support the potential for achieving long-term drug delivery with a single intracochlear administration.

Indexed as

AnimalsAnti-Inflammatory AgentsCochleaDelayed-Action PreparationsDrug Delivery SystemsFluticasoneGuinea PigsHearingPerilymphPilot ProjectsPolymersAnti-Inflammatory AgentsDelayed-Action PreparationsFluticasonePolymers

Identifiers

PMID30199502
PMCPMC6132259

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.