Evidence map›Paper›PMID 37221599›Full record

ReviewJournal of biological engineering2023

Enhancing chemical and physical stability of pharmaceuticals using freeze-thaw method: challenges and opportunities for process optimization through quality by design approach.

Sergio A Bernal-Chávez, Alejandra Romero-Montero, Héctor Hernández-Parra, Sheila I Peña-Corona, María L Del Prado-Audelo, Sergio Alcalá-Alcalá, Hernán Cortés, Lashyn Kiyekbayeva, Javad Sharifi-Rad, Gerardo Leyva-Gómez

Open access · goldAbstract readReview
In one paragraph

Review in Journal of biological engineering, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
11.2field-weighted citation impact, top 1% 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

24 citing papers in PubMed, 73 citations in OpenAlex.

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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

10 authors at 7 institutions in 3 countries.

Sergio A Bernal-ChávezDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, 04510, Mexico.
Alejandra Romero-MonteroDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, 04510, Mexico.
Héctor Hernández-ParraDepartamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Ciudad de México, México.
Sheila I Peña-CoronaDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, 04510, Mexico.
María L Del Prado-AudeloTecnologico de Monterrey, Escuela de Ingeniería y Ciencias, Campus Ciudad de México, Ciudad de México, Mexico.
Sergio Alcalá-AlcaláLaboratorio de Tecnología Farmacéutica, Facultad de Farmacia, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, 62209, México.
Hernán CortésLaboratorio de Medicina Genómica, Departamento de Genómica, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Ciudad de Mexico, Mexico.
Lashyn KiyekbayevaDepartment of Pharmaceutical Technology, Pharmaceutical School, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan.
Javad Sharifi-RadFacultad de Medicina, Universidad del Azuay, Cuenca, Ecuador. javad.sharifirad@gmail.com.
Gerardo Leyva-GómezDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, 04510, Mexico. leyva@quimica.unam.mx.
Universidad Nacional Autónoma de México · MXCentro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional · MXInstituto Nacional de Rehabilitación · MXKazakhstan Medical University · KZTecnológico de Monterrey · MXUniversidad Autónoma del Estado de Morelos · MXUniversidad del Azuay · EC

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The freeze-thaw (F/T) method is commonly employed during the processing and handling of drug substances to enhance their chemical and physical stability and obtain pharmaceutical applications such as hydrogels, emulsions, and nanosystems (e.g., supramolecular complexes of cyclodextrins and liposomes). Using F/T in manufacturing hydrogels successfully prevents the need for toxic cross-linking agents; moreover, their use promotes a concentrated product and better stability in emulsions. However, the use of F/T in these applications is limited by their characteristics (e.g., porosity, flexibility, swelling capacity, drug loading, and drug release capacity), which depend on the optimization of process conditions and the kind and ratio of polymers, temperature, time, and the number of cycles that involve high physical stress that could change properties associated to quality attributes. Therefore, is necessary the optimization of F/T conditions and variables. The current research regarding F/T is focused on enhancing the formulations, the process, and the use of this method in pharmaceutical, clinical, and biological areas. The present review aims to discuss different studies related to the impact and effects of the F/T process on the physical, mechanical, and chemical properties (porosity, swelling capacity) of diverse pharmaceutical applications with an emphasis on their formulation properties, the method and variables used, as well as challenges and opportunities in developing. Finally, we review the experimental approach for choosing the standard variables studied in the F/T method applying the systematic methodology of quality by design.

Indexed as

Chemical propertiesChemical stabilityDrug substancesHydrogelsPharmaceutical applicationsPhysical stability

Identifiers

PMID37221599
PMCPMC10207779
OpenAlexW4377940172

What OpenQuestion 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 OpenQuestion graph.