Evidence map›Paper›PMID 32891940›Full record

ArticleInternational journal of pediatric otorhinolaryngology2020

An extended release ciprofloxacin/dexamethasone hydrogel for otitis media.

Matthew Ku, Shirley Cheung, William Slattery, Erik Pierstorff

Open access · greenAbstract read
In one paragraph

Article in International journal of pediatric otorhinolaryngology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. 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 1 institution in 1 country.

Matthew KuO-Ray Pharma, Inc., 2285 E. Foothill Blvd, Pasadena, 91107, CA, USA. Electronic address: mku@oraypharma.com.
Shirley CheungO-Ray Pharma, Inc., 2285 E. Foothill Blvd, Pasadena, 91107, CA, USA.
William SlatteryO-Ray Pharma, Inc., 2285 E. Foothill Blvd, Pasadena, 91107, CA, USA.
Erik PierstorffO-Ray Pharma, Inc., 2285 E. Foothill Blvd, Pasadena, 91107, CA, USA.
O-Ray Pharma (United States) · US

Funding

Prevention of Children's Tympanostomy Tube OtorrheaR44DC014416 · NIDCD · O-RAY PHARMA, INC. · PI KU, MATTHEW, SLATTERY, WILLIAM H · 2016 to 2020
$1.5M
NIDCD NIH HHS R44 DC014416
6 · The paper itself

Abstract

objectiveOtitis media and associated otorrhea are frequent complications following tympanostomy tube insertion; the most common otologic procedure performed in children in the United States. Current treatments include the administration of antibiotic or antibiotic/anti-inflammatory combination drops to the affected ear. Several studies have demonstrated that using an antibiotic/anti-inflammatory combination product is more effective than the use of antibiotics alone. However, administration of any drops through the tympanostomy tube is very difficult in children, and patient compliance can be an issue. Our group has developed a novel combination drug/hydrogel formulation for the treatment of otitis media/otorrhea that releases both ciprofloxacin and dexamethasone over a 2-3 week period. This has the potential to offer significant advantages over current treatments in use in the clinic.

methodsThe release of drugs from the combination hydrogel was validated in vitro over the desired time frame and the activity of the released drugs was monitored via assays to confirm retention of full activity throughout the dissolution period. The safety of the ciprofloxacin/dexamethasone hydrogel and its inactive excipients was evaluated through in vivo otic toxicity studies in guinea pigs, including hearing tests, gross microscopy, and cytocochleogram analysis.

resultsExtended release of both drugs was demonstrated in vitro and antibiotic/anti-inflammatory activities were retained. The hydrogel components and its excipients did not cause adverse reactions in animals, demonstrating safety of the hydrogel combination in vivo.

conclusionThe studies presented lay the groundwork for extended release middle ear hydrogel formulations that are capable of safely releasing combinations of active pharmaceutical agents over a desired period of time. This would be more advantageous than therapeutics that are currently used in the clinic for the treatment of otitis media/otorrhea associated with tympanostomy tube insertion.

Indexed as

Otitis MediaAdministration, TopicalAnimalsAnti-Bacterial AgentsCiprofloxacinDexamethasoneGuinea PigsHydrogelsMiddle Ear VentilationAnti-Bacterial AgentsCiprofloxacinDexamethasoneHydrogelsCiprofloxacinDexamethasoneHydrogelOtitis mediaOtorrheaTympanostomy tube

Identifiers

PMID32891940
PMCPMC9431770
OpenAlexW3058621835

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.