Division of Applied Regulatory Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland, 20993-0002, USA.
AAPS J. 2024 Jul 10;26(4):79. doi: 10.1208/s12248-024-00950-6.
P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) and multidrug resistance transporter 2 (MRP2) are efflux transporters involved in the absorption, excretion, and distribution of drugs. Bidirectional cell assays are recognized models for evaluating the potential of new drugs as substrates or inhibitors of efflux transporters. However, the assays are complicated by a lack of selective substrates and/or inhibitors, as well simultaneous expression of several efflux transporters in cell lines used in efflux models. This project aims to evaluate an in vitro efflux cell assay employing model substrates and inhibitors of P-gp, BCRP and MRP2 with knockout (KO) cell lines. The efflux ratios (ER) of P-gp (digoxin, paclitaxel), BCRP (prazosin, rosuvastatin), MRP2 (etoposide, olmesartan) and mixed (methotrexate, mitoxantrone) substrates were determined in wild-type C2BBe1 and KO cells. For digoxin and paclitaxel, the ER decreased to less than 2 in the cell lines lacking P-gp expression. The ER decreased to less than 3 for prazosin and less than 2 for rosuvastatin in the cell lines lacking BCRP expression. For etoposide and olmesartan, the ER decreased to less than 2 in the cell lines lacking MRP2 expression. The ER of methotrexate and mitoxantrone decreased in single- and double-KO cells without BCRP and MRP2 expression. These results show that KO cell lines have the potential to better interpret complex drug-transporter interactions without depending upon multi-targeted inhibitors or overlapping substrates. For drugs that are substrates of multiple transporters, the single- and double-KO cells may be used to assess their affinities for the different transporters.
P-糖蛋白(P-gp)、乳腺癌耐药蛋白(BCRP)和多药耐药相关蛋白 2(MRP2)是参与药物吸收、排泄和分布的外排转运体。双向细胞测定被认为是评估新药物作为外排转运体的底物或抑制剂的潜在模型。然而,由于缺乏选择性底物和/或抑制剂,以及外排模型中使用的细胞系同时表达几种外排转运体,因此测定较为复杂。本项目旨在评估一种使用 P-gp、BCRP 和 MRP2 的模型底物和抑制剂的体外外排细胞测定法,采用基因敲除(KO)细胞系。在野生型 C2BBe1 和 KO 细胞中测定 P-gp(地高辛、紫杉醇)、BCRP(普萘洛尔、瑞舒伐他汀)、MRP2(依托泊苷、奥美沙坦)和混合(甲氨蝶呤、米托蒽醌)底物的外排比(ER)。对于地高辛和紫杉醇,在缺乏 P-gp 表达的细胞系中,ER 降低至 2 以下。在缺乏 BCRP 表达的细胞系中,普萘洛尔的 ER 降低至 3 以下,瑞舒伐他汀的 ER 降低至 2 以下。对于依托泊苷和奥美沙坦,在缺乏 MRP2 表达的细胞系中,ER 降低至 2 以下。甲氨蝶呤和米托蒽醌的 ER 在缺乏 BCRP 和 MRP2 表达的单基因和双基因 KO 细胞中降低。这些结果表明,KO 细胞系有可能在不依赖多靶向抑制剂或重叠底物的情况下,更好地解释复杂的药物-转运体相互作用。对于作为多种转运体底物的药物,单基因和双基因 KO 细胞可用于评估它们与不同转运体的亲和力。