Nielsen Rasmus Blaaholm, Holm René, Pijpers Ils, Snoeys Jan, Nielsen Ulla Gro, Nielsen Carsten Uhd
Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark.
Bioanalysis Discovery & Development Sciences, Janssen R & D, Johnson & Johnson, Turnhoutseweg 30, BE-2340 Beerse, Belgium.
Pharmaceutics. 2023 Jan 14;15(1):283. doi: 10.3390/pharmaceutics15010283.
P-glycoprotein (P-gp) limits the oral absorption of drug substances. Potent small molecule P-gp inhibitors (e.g., zosuquidar) and nonionic surfactants (e.g., polysorbate 20) inhibit P-gp by proposedly different mechanisms. Therefore, it was hypothesised that a combination of zosuquidar and polysorbate 20 may potentiate inhibition of P-gp-mediated efflux. P-gp inhibition by zosuquidar and polysorbate 20 in combination was assessed in a calcein-AM assay and in a transcellular etoposide permeability study in MDCKII-MDR1 and Caco-2 cells. Furthermore, solutions of etoposide, zosuquidar, and polysorbate 20 were orally administered to Sprague Dawley rats. Zosuquidar elicited a high level of nonspecific adsorption to various labware, which significantly affected the outcomes of the in vitro studies. Still, at certain zosuquidar and polysorbate 20 concentrations, additive P-gp inhibition was observed in vitro. In vivo, however, oral etoposide bioavailability decreased by coadministration of both zosuquidar and polysorbate 20 when compared to coadministration of etoposide with zosuquidar alone. For future formulation development, the present study provided important and novel knowledge about nonspecific zosuquidar adsorption, as well as insights into combinational P-gp inhibition by a third-generation P-gp inhibitor and a P-gp-inhibiting nonionic surfactant.
P-糖蛋白(P-gp)限制药物的口服吸收。强效小分子P-gp抑制剂(如唑苏达)和非离子表面活性剂(如聚山梨酯20)通过不同的机制抑制P-gp。因此,有人推测唑苏达和聚山梨酯20联合使用可能会增强对P-gp介导的外排的抑制作用。在钙黄绿素-AM测定以及MDCKII-MDR1和Caco-2细胞的跨细胞依托泊苷通透性研究中,评估了唑苏达和聚山梨酯20联合使用对P-gp的抑制作用。此外,将依托泊苷、唑苏达和聚山梨酯20的溶液口服给予Sprague Dawley大鼠。唑苏达对各种实验器具产生高水平的非特异性吸附,这显著影响了体外研究的结果。尽管如此,在某些唑苏达和聚山梨酯20浓度下,体外观察到了相加性的P-gp抑制作用。然而,在体内,与单独将依托泊苷与唑苏达合用相比,同时给予唑苏达和聚山梨酯20时,口服依托泊苷的生物利用度降低。对于未来的制剂开发,本研究提供了关于唑苏达非特异性吸附的重要且新颖的知识,以及对第三代P-gp抑制剂和抑制P-gp的非离子表面活性剂联合抑制P-gp的见解。