Evidence map›Paper›PMID 38212593›Full record

ArticlePharmaceutical research2024

Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes.

Ziyun Xia, Minzhi Yu, Yayuan Liu, Wenmin Yuan, Yan Wang, Xiaoming Xu, Jungeun Bae, Anna Schwendeman

Abstract read
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Article in Pharmaceutical research, 2024. 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
–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

1 citing paper in PubMed.

  1. Trial
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

8 authors.

Ziyun XiaDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA.
Minzhi YuDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA.
Yayuan LiuDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA.
Wenmin YuanDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA.
Yan WangDivision of Therapeutic Performance 1, Office 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 XuDivision of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
Jungeun BaeDivision of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
Anna SchwendemanDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA. annaschw@med.umich.edu.ORCID http://orcid.org/0000-0002-8023-8080

Funding

U.S. Food and Drug Administration 75F40120C00127
6 · The paper itself

Abstract

purposeA multivesicular liposome (MVL) is a liposomal vehicle designed to achieve sustained release characteristics for drugs with short half-lives. For example, a commercial MVL formulation of bupivacaine has been approved by the U.S. Food and Drug Administration for local and regional analgesia. For complex formulations like those containing MVLs, challenges in developing an in vitro release testing (IVRT) method may hinder generic development and regulatory approval. In this study, we developed an accelerated rotator-based IVRT method with the ability to discriminate bupivacaine MVLs with different quality attributes.

methodsThree IVRT experimental setups including mesh tube, horizontal shaker, and vertical rotator were screened to ensure that at least 50% of bupivacaine can release from MVLs in 24 h. Sample dilution factors, incubation temperature, and the release media pH were optimized for the IVRT. The reproducibility of the developed IVRT method was validated with commercial bupivacaine MVLs. The discriminative capacity was assessed via comparing commercial and compromised bupivacaine MVL formulations.

resultsThe rotator-based release setup was chosen due to the capability to obtain 70% of drug release within 24 h. The optimized testing conditions were chosen with a 50-fold dilution factor, a temperature of 37ºC, and a media pH of 7.4.

conclusionsAn accelerated rotator-based IVRT method for bupivacaine MVLs was developed in this study, with the discriminatory ability to distinguish between formulations of different qualities. The developed IVRT method was a robust tool for generic development of MVL based formulations.

Indexed as

BupivacaineLiposomesDelayed-Action PreparationsDrug LiberationReproducibility of ResultsBupivacaineDelayed-Action PreparationsLiposomesbupivacainegeneric developmentin vitro release methodliposomesmultivesicular liposomes

Identifiers

PMID38212593

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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.