Evidence mapPaperPMID 41900837Full record

ReviewPharmaceutics2026

PLGA-Based In Situ-Forming Implants, a Quality by Design Perspective.

Nayelli Campos-Morales, Luz Graciela Cervantes-Pérez, Alicia Sánchez-Mendoza, María Sánchez-Aguilar, José Juan Escobar-Chávez, Lizbeth Martínez-Acevedo, Moises Job Galindo-Pérez, Jorge Esteban Miranda-Calderon

Abstract readReview
In one paragraph

Review in Pharmaceutics, 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
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

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

8 authors.

Nayelli Campos-MoralesCiencias Farmacéuticas, Universidad Autónoma Metropolitana, Unidad Xochimilco, Calzada del Hueso 1100, Colonia Villa Quietud, Alcaldía Coyoacán, Mexico City C.P. 04960, Mexico.ORCID 0009-0003-0174-4263
Luz Graciela Cervantes-PérezInstituto Nacional de Cardiología, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, Mexico City C.P. 14080, Mexico.ORCID 0000-0002-1737-3458
Alicia Sánchez-MendozaInstituto Nacional de Cardiología, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, Mexico City C.P. 14080, Mexico.
María Sánchez-AguilarInstituto Nacional de Cardiología, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, Mexico City C.P. 14080, Mexico.ORCID 0000-0002-6697-0208
José Juan Escobar-ChávezUnidad de Investigación Multidisciplinaria-L 12, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México, Carretera Cuautitlán-Teoloyucan, Km 2.5 San Sebastián Xhala, Cuautitlán Izcalli C.P. 54714, Estado de Mexico, Mexico.ORCID 0000-0001-9229-2941
Lizbeth Martínez-AcevedoDepartamento de Sistemas Biológicos, Universidad Autónoma Metropolitana, Unidad Xochimilco, Calzada del Hueso 1100, Colonia Villa Quietud, Alcaldía Coyoacán, Mexico City C.P. 04960, Mexico.
Moises Job Galindo-PérezDepartamento de Procesos y Tecnología, Universidad Autónoma Metropolitana, Unidad Cuajimalpa, Av. Vasco de Quiroga 4871, Santa Fe Cuajimalpa, Mexico City C.P. 05348, Mexico.
Jorge Esteban Miranda-CalderonDepartamento de Sistemas Biológicos, Universidad Autónoma Metropolitana, Unidad Xochimilco, Calzada del Hueso 1100, Colonia Villa Quietud, Alcaldía Coyoacán, Mexico City C.P. 04960, Mexico.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In situ-forming implants (ISFIs) based on poly(lactic-co-glycolic acid) (PLGA) offer a promising platform for long-acting parenteral drug delivery, enabling minimally invasive administration without surgical implantation. However, the development and clinical translation of PLGA-based ISFIs are hindered by formulation complexity, sensitivity to aterial variability, and limited predictability of drug release, particularly during early implant formation. Although previous reviews have described formulation components and release mechanisms, a comprehensive integration of Quality by Design (QbD) principles with a focus on risk prioritization remains absent. This review examines the application of QbD to solvent-exchange PLGA-based ISFIs, with an emphasis on identifying critical material attributes (CMAs) governing implant formation, burst release, and long-term release performance. Risk-based prioritization of CMAs and the role of design of experiments are systematically discussed. Special attention is given to burst release as a major CMA affecting safety, efficacy, and translational robustness. The evidence indicates that formulation-driven CMAs, such as polymer physicochemical properties, drug characteristics, and solvent selection, exert a greater influence on ISFI performance than process-related parameters. This review provides a structured perspective to support rational formulation design, improved reproducibility, and enhanced clinical translation of PLGA-based ISFI systems.

Indexed as

implantinjectableQbD

Identifiers

PMID41900837
PMCPMC13029307

What Socratic holds

Textmetadata
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 Socratic graph.