Evidence map›Paper›PMID 39065784›Full record

ArticlePharmaceuticals (Basel, Switzerland)2024

Exploring Vacuum Compression Molding as a Preparation Method for Flexible-Dose Pediatric Orodispersible Films.

Dana Hales, Cătălina Bogdan, Lucia Ruxandra Tefas, Andreea Cornilă, Maria-Andreea Chiver, Ioan Tomuță, Tibor Casian, Rareș Iovanov, Gábor Katona, Rita Ambrus and 1 more

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 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. 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

11 authors.

Dana HalesDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.
Cătălina BogdanDepartment of Dermopharmacy and Cosmetology, Iuliu Hatieganu University of Medicine and Pharmacy, 12 Ion Creangă St, 400002 Cluj-Napoca, Romania.
Lucia Ruxandra TefasDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.
Andreea CornilăDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.ORCID 0000-0002-3901-0738
Maria-Andreea ChiverDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.
Ioan TomuțăDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.ORCID 0000-0002-5094-008X
Tibor CasianDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.
Rareș IovanovDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.
Gábor KatonaInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eotvos u. 6, 6720 Szeged, Hungary.ORCID 0000-0003-1564-4813
Rita AmbrusInstitute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eotvos u. 6, 6720 Szeged, Hungary.ORCID 0000-0001-5496-1710
Sonia IurianDepartment of Pharmaceutical Technology and Biopharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, 41 Victor Babeș St, 400002 Cluj-Napoca, Romania.

Funding

Romanian Ministry of Research, Innovation and Digitization PN-III-P2-2.1-PED-2021-4198
6 · The paper itself

Abstract

In recent years, solid dosage forms have gained interest in pediatric therapy because they can provide valuable benefits in terms of dose accuracy and stability. Particularly for orodispersible films (ODFs), the literature evidences increased acceptability and dose flexibility. Among the various available technologies for obtaining ODFs, such as solvent casting, hot-melt extrusion, and ink printing technologies, the solvent-free preparation methods exhibit significant advantages. This study investigated Vacuum Compression Molding (VCM) as a solvent-free manufacturing method for the preparation of flexible-dose pediatric orodispersible films. The experimental approach focused on selecting the appropriate plasticizer and ratios of the active pharmaceutical ingredient, diclofenac sodium, followed by the study of their impacts on the mechanical properties, disintegration time, and drug release profile of the ODFs. Additional investigations were performed to obtain insights regarding the solid-state properties. The ODFs obtained by VCM displayed adequate quality in terms of their critical characteristics. Therefore, this proof-of-concept study shows how VCM could be utilized as a standalone method for the production of small-scale ODFs, enabling the customization of doses to meet the individual needs of pediatric patients.

Indexed as

diclofenac sodiumorodispersible filmspediatric formulationsvacuum compression molding

Identifiers

PMID39065784
PMCPMC11280104

What OpenQuestion holds

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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.