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<p>In this study, orodispersible films (ODFs) were developed as fast-releasing formulations for pediatric patients suffering from Lennox-Gastaut or Dravet syndrome, with cannabidiol (CBD) selected as the active pharmaceutical ingredient (API). The properties of the ODFs were evaluated both before and after casting, with a focus on establishing a correlation between the properties of colloidal dispersion/suspension and ODFs to enhance understanding of the manufacturing process. Two blank colloidal dispersions were characterized for spreadability, viscosity, tangential stress, and pH, and their properties were correlated with those of blank ODFs, including mass uniformity, thickness, folding endurance, thickness-normalized crushing strength, disintegration time (evaluated through two different methods) and adhesivity. The strength and direction of the correlation were established via the Pearson coefficient. The same statistical approach was applied to assess correlation between CBD suspension (DCBD1, DCBD2) properties and CBD-ODF parameters. For the suspensions, particle size evaluation was also considered. Although few statistically significant positive or negative correlations were observed, a notable finding of this study was the dissolution behavior of CBD-ODF2, where nearly 100% of the API was released at 30&#xa0;min, which is consistent with the disintegration behavior evaluated through the pharmacopeial method. Notably, CBD is classified as a Biopharmaceutical Classification System (BCS) Class II compound.</p>

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Exploring the interconnected properties of cannabidiol suspensions and orodispersible films

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月1日

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  • Robert-Alexandru Vlad,
  • Andrada Pintea,
  • Paula Antonoaea,
  • Emöke-Margit Rédai,
  • Magdalena Bîrsan,
  • Gabriel Hancu,
  • Lénárd Farczádi,
  • Silvia Imre,
  • Daniela-Lucia Muntean,
  • Tamás Sovány,
  • Katalin Kristó,
  • Krisztina Ludasi,
  • Géza Regdon Jr.,
  • Adriana Ciurba

摘要

In this study, orodispersible films (ODFs) were developed as fast-releasing formulations for pediatric patients suffering from Lennox-Gastaut or Dravet syndrome, with cannabidiol (CBD) selected as the active pharmaceutical ingredient (API). The properties of the ODFs were evaluated both before and after casting, with a focus on establishing a correlation between the properties of colloidal dispersion/suspension and ODFs to enhance understanding of the manufacturing process. Two blank colloidal dispersions were characterized for spreadability, viscosity, tangential stress, and pH, and their properties were correlated with those of blank ODFs, including mass uniformity, thickness, folding endurance, thickness-normalized crushing strength, disintegration time (evaluated through two different methods) and adhesivity. The strength and direction of the correlation were established via the Pearson coefficient. The same statistical approach was applied to assess correlation between CBD suspension (DCBD1, DCBD2) properties and CBD-ODF parameters. For the suspensions, particle size evaluation was also considered. Although few statistically significant positive or negative correlations were observed, a notable finding of this study was the dissolution behavior of CBD-ODF2, where nearly 100% of the API was released at 30 min, which is consistent with the disintegration behavior evaluated through the pharmacopeial method. Notably, CBD is classified as a Biopharmaceutical Classification System (BCS) Class II compound.