Evidence map›Paper›PMID 40645309›Full record

ArticleInternational journal of pharmaceutics2025

Impact of polymer source variations on hydrogel structure and product performance in dexamethasone-loaded ophthalmic inserts.

Michael A VandenBerg, Rokon Uz Zaman, Christine L Plavchak, William C Smith, Hossein Birjandi Nejad, Andre O'Reilly Beringhs, Yan Wang, Xiaoming Xu

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Michael A VandenBergOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Rokon Uz ZamanOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Christine L PlavchakOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
William C SmithOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Hossein Birjandi NejadOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA; Medical Products Inspectorate, Office of Inspections and Investigations, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Andre O'Reilly BeringhsOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Yan WangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.
Xiaoming XuOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: Xiaoming.Xu@fda.hhs.gov.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Localized drug delivery can enhance therapeutic efficacy while minimizing systemic side effects, making sustained-release ophthalmic inserts an attractive alternative to traditional eye drops. Such inserts offer improved patient compliance through prolonged therapeutic effects and a reduced need for frequent administration. This study focuses on dexamethasone-containing ophthalmic inserts. These inserts utilize a key excipient, polyethylene glycol (PEG), which forms a hydrogel upon contact with tear fluid. Developing generic equivalents of PEG-based inserts is challenging due to difficulties in characterizing inactive ingredients and the absence of standardized physicochemical characterization methods to demonstrate similarity. To address this gap, a suite of analytical approaches was applied to both PEG precursor materials sourced from different vendors and manufactured inserts.

Indexed as

DexamethasoneHydrogelsPolyethylene GlycolsAdministration, OphthalmicChemistry, PharmaceuticalDelayed-Action PreparationsDrug Delivery SystemsDrug LiberationExcipientsPolymersPorosityDelayed-Action PreparationsDexamethasoneExcipientsHydrogelsPolyethylene GlycolsPolymersDexamethasoneDrug releaseExcipient variabilityHydrogelIn vitro characterizationOphthalmic insertPEG

Identifiers

PMID40645309
PMCPMC12635916

What OpenQuestion holds

Textmetadata
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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.