3D Printed Bigel: A Novel Delivery System for Cannabidiol-Rich Hemp Extract

Abstract

The therapeutic potential of Cannabis sativa L. extract has gained significant attention due to its diverse medical applications. Sublingual administration remains a common delivery method of cannabinoids; however, challenges often arise due to the inconvenient form of the extract and its taste. To address these issues, a novel bigel formulation was developed, combining water and oil phases to enhance stability and bioavailability. This formulation incorporates a cannabidiol-rich hemp extract, hyaluronic acid for its moisturizing properties, and a taste-masking agent to improve patient compliance and comfort. Using a standardized hemp extract rich in cannabinoids and a well-characterized terpene profile, the printability of the bigels was evaluated through 3D printing technology. A printout with known cannabidiol (CBD) and cannabidiolic acid (CBDA) content of 11.613 mg ± 0.192 of CBD and 4.732 mg ± 0.280 of CBDA in the printout was obtained. In addition, the release profile of CBD and CBDA was evaluated to determine the delivery efficiency of the active ingredient—dissolved active ingredient levels ranged from 74.84% ± 0.50 to 80.87% ± 3.20 for CBD and from 80.84 ± 1.33 to 98.31 ± 1.70 for CBDA depending on the formulation. Rheological studies were conducted to evaluate the viscosity of the bigels under varying temperature conditions, ensuring their stability and usability. Findings suggest that this 3D-printed bigel formulation could significantly enhance the delivery of cannabis extracts, offering a more convenient and effective therapeutic option for patients. This research underscores the importance of innovation in cannabinoid therapies and paves the way for further advancements in personalized medicine.

摘要
大麻（Cannabis sativa L.）提取物因其多样的医学应用场景，其治疗潜力已受到广泛关注。舌下给药仍是大麻素类物质常用的给药方式，但该提取物剂型不便且口感不佳，常带来使用难题。为解决上述问题，本研究开发了一种新型双相凝胶（bigel）制剂，通过整合水相与油相来提升制剂稳定性与生物利用度。该制剂添加了富含大麻二酚（cannabidiol, CBD）的大麻提取物、具备保湿功效的透明质酸，以及掩味剂，以提升患者用药依从性与使用舒适度。本研究采用成分标准化的富大麻素大麻提取物及表征完善的萜烯谱，通过3D打印技术评估了该双相凝胶的可打印性能，最终获得的打印样品中，CBD与大麻酸（cannabidiolic acid, CBDA）的含量分别为11.613 mg ± 0.192 mg与4.732 mg ± 0.280 mg。此外，本研究还评估了CBD与CBDA的体外释放曲线，以明确活性成分的递送效率：不同制剂配方下，CBD的溶解活性成分占比为74.84% ± 0.50%至80.87% ± 3.20%，CBDA的对应占比为80.84% ± 1.33%至98.31% ± 1.70%。本研究开展流变学实验，评估了不同温度条件下双相凝胶的黏度，以保障制剂的稳定性与可用性。研究结果表明，该3D打印双相凝胶制剂可显著提升大麻提取物的递送效果，为患者提供更便捷且高效的治疗选择。本研究凸显了大麻素治疗领域创新的重要价值，同时为个性化医疗的进一步发展铺平了道路。