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用于提高溶解度和生物利用度的大麻二酚固体自纳米乳化药物递送系统的制剂与评价

Formulation and Evaluation of Solid Self-Nanoemulsifying Drug Delivery System of Cannabidiol for Enhanced Solubility and Bioavailability.

作者信息

Wu Fengying, Ma Qing, Tian Guanghui, Chen Kaixian, Yang Rulei, Shen Jingshan

机构信息

School of Chinese Materia Medica, Nanjing University of Chinese Medicine, Nanjing 210023, China.

State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.

出版信息

Pharmaceutics. 2025 Mar 6;17(3):340. doi: 10.3390/pharmaceutics17030340.

DOI:10.3390/pharmaceutics17030340
PMID:40143004
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11944824/
Abstract

This study aims to develop a solid self-nanoemulsifying drug delivery system (SNEDDS) to enhance the solubility and oral bioavailability of cannabidiol (CBD). According to the solubility of CBD and pseudo-ternary phase diagrams of the different ingredients, an oil (medium-chain triglyceride, MCT), mixed surfactants (Labrasol, Tween 80), and a co-surfactant (Transcutol) were selected for the SNEDDS. CBD-loaded SNEDDS formulations were prepared and characterized. The optimal SNEDDS was converted into solid SNEDDS powders via solid carrier adsorption and spray drying techniques. Various evaluations including flowability, drug release, self-emulsifying capacity, X-ray diffraction (XRD), differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), morphology, and pharmacokinetic characteristics were conducted. Subsequently, the solid powders with fillers, disintegrants, and lubricants were added to the capsules for accelerated stability testing. The investigations showed that the two S-SNEDDS formulations improved the CBD's solubility and in vitro drug release, with good storage stability. The pharmacokinetic data of Sprague Dawley rats indicated that a single oral dose of L-SNEDDS and spray drying SNEDDS led to a quicker absorption and a higher Cmax of CBD compared to the two oil-based controls (CBD-sesame oil (similar to Epidiolex) and CBD-MCT), which is favorable for the application of CBD products. SNEDDS is a prospective strategy for enhancing the solubility and oral bioavailability of CBD, and solid SNEDDS offers flexibility for developing more CBD-loaded solid formulations. Moreover, SNEDDS provides new concepts and methods for other poorly water-soluble drugs.

摘要

本研究旨在开发一种固体自纳米乳化药物递送系统（SNEDDS），以提高大麻二酚（CBD）的溶解度和口服生物利用度。根据CBD的溶解度以及不同成分的伪三元相图，为SNEDDS选择了一种油（中链甘油三酯，MCT）、混合表面活性剂（Labrasol、吐温80）和一种助表面活性剂（肉豆蔻酸异丙酯）。制备并表征了载CBD的SNEDDS制剂。通过固体载体吸附和喷雾干燥技术将最佳的SNEDDS转化为固体SNEDDS粉末。进行了包括流动性、药物释放、自乳化能力、X射线衍射（XRD）、差示扫描量热法（DSC）、傅里叶变换红外光谱（FTIR）、形态学和药代动力学特征等各种评价。随后，将含有填充剂、崩解剂和润滑剂的固体粉末加入胶囊中进行加速稳定性试验。研究表明，两种S-SNEDDS制剂提高了CBD的溶解度和体外药物释放，具有良好的储存稳定性。Sprague Dawley大鼠的药代动力学数据表明，与两种油基对照（CBD-芝麻油（类似于Epidiolex）和CBD-MCT）相比，单次口服剂量的L-SNEDDS和喷雾干燥SNEDDS导致CBD吸收更快、Cmax更高，这有利于CBD产品的应用。SNEDDS是提高CBD溶解度和口服生物利用度的一种前瞻性策略，固体SNEDDS为开发更多载CBD的固体剂型提供了灵活性。此外，SNEDDS为其他难溶性药物提供了新的概念和方法。

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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/37a9/11944824/07e7fd9f6365/pharmaceutics-17-00340-g008.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/37a9/11944824/12260c40e911/pharmaceutics-17-00340-g013.jpg

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