Evidence map›Paper›PMID 37679656›Full record

ArticlePharmaceutical research2023

Impact of Apparatus and Adapter on In vitro Drug Release of Ophthalmic Semisolid Drug Products.

Catheleeya Mekjaruskul, André O'Reilly Beringhs, Bin Qin, Yan Wang, Pallabita Chowdhury, Xiuling Lu

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 39% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. International journal of pharmaceutics: X · 2026
    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

6 authors at 3 institutions in 2 countries.

Catheleeya MekjaruskulDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA.
André O'Reilly BeringhsDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Bin QinDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Yan WangDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Pallabita ChowdhuryDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA.
Xiuling LuDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA. xiuling.lu@uconn.edu.ORCID http://orcid.org/0000-0002-1961-8156
United States Food and Drug Administration · USUniversity of Connecticut · USMahasarakham University · TH

Funding

FDA HHS HHSF223201810114C
6 · The paper itself

Abstract

purposeIn vitro release testing (IVRT) is a widely used tool for evaluating the quality and performance of drug products. However, standardized sample adaptors or drug release apparatus setups for IVRT studies are still lacking for ophthalmic ointments. The aim of this study was to provide a better understanding of the impact of apparatus and sample adaptor setups on IVRT of ophthalmic ointments.

methodsDexamethasone (DEX), a steroidal ingredient commonly used in ophthalmic drug products, was selected as a model drug. Ointments were prepared by mixing DEX in white petrolatum using a high shear mixer. A novel two-sided adapter was developed to increase the drug release surface area. DEX ointment was placed in one-sided or two-sided release adaptors coupled with 1.2 μm polyethersulfone membrane, and the drug release was studied in different USP apparatuses (I, II, and IV).

resultsThe sample adaptor setups had a minimal impact on cumulative drug release amount per area or release rate while USP IV apparatus with agitated flow enhanced drug release rates. The USP apparatus I with a two-sided semisolid adapter, which uses membranes on both sides, showed dramatically higher cumulative drug release and discriminative release profiles when evaluating ophthalmic formulations.

conclusionsUSP apparatuses and sample adaptors are critical considerations for IVRT. Two-sided semisolid adapter provides higher cumulative release, facilitating the discrimination between low drug content ophthalmic ointment formulations with good sensitivity and repeatability without affecting the drug release rate.

Indexed as

Drug LiberationAdministration, OphthalmicDrug CompoundingOintmentsOintmentsdissolution apparatusin vitro release testmembraneointment

Identifiers

PMID37679656
OpenAlexW4386527862

What OpenQuestion holds

Textmetadata
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.