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Purpose <p>Ursodeoxycholic 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&#xa0;mg of UDCA/film) for chronic oral administration to pediatric patients.</p> Methods <p>Films were developed with mannuronic acid-rich alginate by casting. They were evaluated for 18&#xa0;months-storage at 25&#xa0;°C and 33.3% relative humidity (RH).</p> Results <p>UDCA powder crystallinity decreased from 75% to 28–32% in UDCA films. Film water content decreased with increasing UDCA dose. Glass transition temperature (<i>T</i><sub>g</sub>) increased from ‒129.15ºC (UDCA powder) to ≈ ‒80ºC for UDCA films (33.3% RH), while 0% RH UDCA powder (80% crystallinity) had not <i>T</i><sub>g</sub>. Film-FTIR spectra demonstrated that UDCA particles were buried or coated by the alginate film network. Films showed homogeneous UDCA distribution, adequate tensile strength, rapid swelling and disintegration (43–58&#xa0;s), and UDCA content within USP specifications for 18&#xa0;months.</p> Conclusions <p>Amorphous 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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年10月28日

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

摘要

Purpose

Ursodeoxycholic 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.

Methods

Films 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).

Results

UDCA powder crystallinity decreased from 75% to 28–32% in UDCA films. Film water content decreased with increasing UDCA dose. Glass transition temperature (Tg) increased from ‒129.15ºC (UDCA powder) to ≈ ‒80ºC for UDCA films (33.3% RH), while 0% RH UDCA powder (80% crystallinity) had not Tg. Film-FTIR spectra demonstrated that UDCA particles were buried or coated by the alginate film network. Films showed homogeneous UDCA distribution, adequate tensile strength, rapid swelling and disintegration (43–58 s), and UDCA content within USP specifications for 18 months.

Conclusions

Amorphous 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.