探索大麻二酚悬浮液和口腔崩解膜的相互关联特性。

Exploring the interconnected properties of cannabidiol suspensions and orodispersible films.

作者信息

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

机构信息

Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, "George Emil Palade", University of Medicine, Pharmacy, Science and Technology of Târgu Mureș, 38 Gheorghe Marinescu Street, Târgu Mureș, 540142, Romania.

Drug Industry and Pharmaceutical Biotechnology Department, Faculty of Pharmacy, "Grigore T. Popa", University of Medicine and Pharmacy from Iași, 16 Universităţii Street, 700115, Iași, Romania.

出版信息

Sci Rep. 2025 Jul 1;15(1):21564. doi: 10.1038/s41598-025-02859-2.

Abstract

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.

摘要

在本研究中,口腔崩解膜(ODF)被开发为患有伦诺克斯 - 加斯东综合征或德雷维特综合征的儿科患者的速释制剂,选择大麻二酚(CBD)作为活性药物成分(API)。在浇铸前后对ODF的性质进行了评估,重点是建立胶体分散体/悬浮液与ODF性质之间的相关性,以增强对制造过程的理解。对两种空白胶体分散体的铺展性、粘度、切向应力和pH值进行了表征,并将其性质与空白ODF的性质相关联,包括质量均匀性、厚度、耐折性、厚度归一化抗压强度、崩解时间(通过两种不同方法评估)和粘附性。通过皮尔逊系数确定相关性的强度和方向。采用相同的统计方法评估CBD悬浮液(DCBD1、DCBD2)性质与CBD - ODF参数之间的相关性。对于悬浮液,还考虑了粒度评估。尽管观察到的统计学上显著的正相关或负相关较少,但本研究的一个显著发现是CBD - ODF2的溶出行为,其中近100%的API在30分钟时释放,这与通过药典方法评估的崩解行为一致。值得注意的是,CBD被归类为生物药剂学分类系统(BCS)II类化合物。

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