Evidence map›Paper›PMID 41148572›Full record

ArticlePharmaceutical research2025

Novel orally Disintegrating Edible Films with Ursodeoxycholic Acid for the Treatment of Hepatobiliary Diseases in Pediatric Patients.

Oriana Boscolo, Sabrina Flor, Camila Olivera, Cecilia Beatriz Dobrecky, Sergio Teves, Ana Maria Rojas, Silvia Lucangioli

Abstract read
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Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited 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

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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

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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

7 authors.

Oriana BoscoloFacultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.
Sabrina FlorFacultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.
Camila OliveraFacultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.
Cecilia Beatriz DobreckyFacultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.
Sergio TevesFacultad de Farmacia y Bioquímica, Departamento de Microbiología, Inmunología, Biotecnología y Genética, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.
Ana Maria RojasFacultad de Ciencias Exactas y Naturales, Departamento de Industrias-ITAPROQ, Universidad de Buenos Aires, Int. Güiraldes 2620, Ciudad Universitaria, Buenos Aires, C1428BGA, Argentina. arojas@di.fcen.uba.ar.
Silvia LucangioliFacultad de Farmacia y Bioquímica, Departamento de Tecnología Farmacéutica, Universidad de Buenos Aires, Junín 956, Buenos Aires, C1113AAD, Argentina.

Funding

Agencia Nacional de Promoción Científica y Tecnológica PE PPM 2021-2024 - Línea 2-B Proyecto N° 0006Agencia Nacional de Promoción Científica y Tecnológica PICT 2017-1146Consejo Nacional de Investigaciones Científicas y Técnicas 2021-2023 GIConsejo Nacional de Investigaciones Científicas y Técnicas PIP 112-202001-01800 COUniversidad de Buenos Aires 20020170100229BAUniversidad de Buenos Aires 20020220300155BA
6 · The paper itself

Abstract

purposeUrsodeoxycholic acid (UDCA) has low toxicity and restores biochemical parameters in cholestatic preschoolers and children. The edible film is a new dosage form included in USP-NF 2023. The objective was to design edible UDCA films (25 and 50 mg of UDCA/film) for chronic oral administration to pediatric patients.

methodsFilms were developed with mannuronic acid-rich alginate by casting. They were evaluated for 18 months-storage at 25 °C and 33.3% relative humidity (RH).

resultsUDCA powder crystallinity decreased from 75% to 28-32% in UDCA films. Film water content decreased with increasing UDCA dose. Glass transition temperature (T

conclusionsAmorphous systems like these films can improve solubility and oral bioavailability of poorly water-soluble UDCA. Moreover, flexible alginate films ensure not only UDCA stability but also treatment adherence for pediatric oral simple administration given also the alginate taste-masking properties.

Indexed as

Biliary Tract DiseasesCholagogues and CholereticsEdible FilmsLiver DiseasesUrsodeoxycholic AcidAdministration, OralAlginatesBiological AvailabilityChildChild, PreschoolDrug StabilityHumansPowdersSolubilityTensile StrengthAlginatesCholagogues and CholereticsPowdersUrsodeoxycholic Acidamorphous solid-like systemscholestatic liver diseasemannuronic-rich alginatepediatric oral edible filmsursodeoxycholic acid

Identifiers

PMID41148572

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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.