Evidence map›Paper›PMID 42380405›Full record

ArticlePharmaceutical research2026

Impact of Mixing Approach and Bubble Formation on In Situ Forming Implant Properties.

Xinhao Lin, Seyyed Majid Eslami, Zixuan Zhen, Hong Yuan, Eric Wilson Livingston, Ananya Aggarwal, Mia Atallah, Andre O'Reilly Beringhs, Qi Li, Qiangnan Zhang and 3 more

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Xinhao Lin *Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, USA.
Seyyed Majid Eslami *Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, USA.
Zixuan ZhenDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, USA.
Hong YuanDepartment of Radiology, Biomedical Research Imaging Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
Eric Wilson LivingstonDepartment of Radiology, Biomedical Research Imaging Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
Ananya AggarwalDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, USA.
Mia AtallahDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, 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.
Qi LiOffice 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.
Qiangnan ZhangOffice 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.
Qin BinOffice 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.
Xiuling LuDepartment of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, 06269, USA. xiuling.lu@uconn.edu.ORCID http://orcid.org/0000-0002-1961-8156

Funding

Intramural FDA HHS FD999999U.S. Food and Drug Administration 75F40120C00136
6 · The paper itself

Abstract

purposeThe commercial In situ forming implants (ISFIs) use either a dual-syringe system requiring pre-injection syringe mixing, or a pre-mixed ready-to-inject syringe. The purpose of this study is to comprehensively evaluate the impact of these two mixing approaches on ISFIs' properties as well as in vitro performance.

methodsComputed tomography (CT) imaging and scanning electron microscopy were used to access implant structure ad morphology. High-performance liquid chromatography was used for drug release determination. Gel permeation chromatography was used to evaluate polymer degradation. The CT contrast agent iohexol was used as a model compound and was fully dissolved in the matrix regardless of the mixing approach.

resultsSyringe-mixed ISFIs contained air bubbles, while ready-to-inject formulation displayed a more uniform polymer matrix without them. The introduction of air bubbles exhibited slower solvent NMP release, altered drug deposition, increased volume expansion, and enhanced initial degradation rate. CT imaging revealed that ready-to-inject formulation was more uniform, whereas syringe-mixed implants appeared to have more heterogenous cavity feature.

conclusionsThe introduction of air bubbles through pre-injection mixing could potentially impact drug release and ISFI's performance. This study elucidates the comparison between two mixing techniques as a reference in the developmental process of future products.

Indexed as

Drug ImplantsChemistry, PharmaceuticalContrast MediaDrug CompoundingDrug LiberationIohexolMicroscopy, Electron, ScanningPolymersSyringesTomography, X-Ray ComputedContrast MediaDrug ImplantsIohexolPolymersCT imagingdrug releasein situ forming implantiohexolmixing method

Identifiers

PMID42380405
PMCPMC13621369

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Registered trials

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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.