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Improved dissolution and oral absorption by co-grinding active drug probucol and ternary stabilizers mixtures with planetary beads-milling method

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Asian Journal of Pharmaceutical Sciences 2019年第6期14卷 649-657页

作者： Fang Li Linsen Li Shaoning Wang Yan Yang Jia Li Dongchun Liu Sijie Zhang Siling Wang Hui Xu School of Pharmacy Shenyang Pharmaceutical UniversityBenxi 117004China Shenyang Medical College Shenyang 110031China School of Pharmaceutical Engineering Shenyang Pharmaceutical UniversityBenxi 117004China School of Traditional Chinese Medicine Shenyang Pharmaceutical UniversityBenxi 117004China

The objective of this work is to construct a nanosuspension drug delivery system of probucol,a BCS II drug,in order to improve its dissolution and oral bioavailability.The wet milling procedure using planetary beads-milling equipment was utilized to grind the raw probucol to ultrafine nanoparticle/nanocrystal aqueous suspension that was further solidified by freeze-drying process.Cellulose derivatives of different substitution groups and molecular weights,including HPMC,HPC,and MC,were evaluated as the primary stabilizer of probucol nanosuspension.Ternary stabilizers system composed of a primary stabilizer(cellulose derivative,i.e.HPC),a nonionic surfactant(Pluronic R F68),and an anionic surfactant(SDS)was employed to obtain probucol nanosuspension of finer particle size and enhanced dissolution in aqueous media.The probucol nanosuspension with good physical stability showed no obvious change of particle size even after storing over 7 d at 4°C or 25°C.The solidified probucol nanosuspension with trehalose as the cryoprotectant showed the highest dissolution rate(>60%at 2 h)compared to other cryoprotectant.The in vivo pharmacokinetic evaluation indicated about 15-folds higher AUC value of the probucol nanosuspension compared to that of coarse probucol suspension after oral administration to rats.The probucol nanosuspension prepared by wet-milling and ternary stabilizers system may find wide applications for improving the dissolution and oral absorption of water-insoluble drugs.

关键词： Probucol Nanosuspension Ternary stabilizers systems Planetary beads-milling Bioavailability

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