Evidence map›Paper›PMID 30680326›Full record

ArticleBioengineering & translational medicine2019

Device design methodology and formulation of a protein therapeutic for sustained release intraocular delivery.

Erica B Schlesinger, Daniel A Bernards, Hunter H Chen, James Feindt, Jingtai Cao, Daniel Dix, Carmelo Romano, Robert B Bhisitkul, Tejal A Desai

Abstract read
In one paragraph

Article in Bioengineering & translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Review
  2. Progress in Ocular Drug Delivery: Challenges and Constraints.Handbook of experimental pharmacology · 2024
    Article
  3. Article
  4. Review
  5. Article
  6. Bioengineering & translational medicine · 2020
    Article
  7. Article
  8. Review
  9. 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

9 authors.

Erica B SchlesingerGraduate Program in Bioengineering University of California San Francisco CA 94158.
Daniel A BernardsDept. of Bioengineering and Therapeutic Sciences University of California San Francisco CA 94158.
Hunter H ChenFormulation Development Group Regeneron Pharmaceuticals Tarrytown NY 10591.
James FeindtFormulation Development Group Regeneron Pharmaceuticals Tarrytown NY 10591.
Jingtai CaoOphthalmology Research Regeneron Pharmaceuticals Tarrytown NY 10591.
Daniel DixFormulation Development Group Regeneron Pharmaceuticals Tarrytown NY 10591.
Carmelo RomanoOphthalmology Research Regeneron Pharmaceuticals Tarrytown NY 10591.
Robert B BhisitkulDept. of Ophthalmology University of California San Francisco CA 94158.
Tejal A DesaiGraduate Program in Bioengineering University of California San Francisco CA 94158.

Funding

Rapid-Prototyping and Design CoreP30EY002162 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LAKKARAJU, APARNA · 1985 to 2024
$16.8M
Nanoporous Films for Ocular Drug DeliveryR01EY021574 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DESAI, TEJAL A. · 2011 to 2014
$1.5M
NEI NIH HHS P30 EY002162NEI NIH HHS R01 EY021574
6 · The paper itself

Abstract

Despite years of effort, sustained delivery of protein therapeutics remains an unmet need due to three primary challenges - dose, duration, and stability. The work presented here provides a design methodology for polycaprolactone reservoir-based thin film devices suitable for long-acting protein delivery to the back of the eye. First, the challenge of formulating highly concentrated protein in a device reservoir was addressed by improving stability with solubility-reducing excipients. Next, predictive correlations between design parameters and device performance were developed to provide a methodology to achieve a target product profile. Prototype devices were designed using this methodology to achieve desired device size, release rate, therapeutic payload, and protein stability, assessed by

Indexed as

drug deliveryintravitreal devicepolycaprolactoneprotein formulationsustained deliverythin film device

Identifiers

PMID30680326
PMCPMC6336666

What OpenQuestion holds

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LicenceCC BY
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.