Department of Bioengineering, Stanford University, Stanford, CA, USA.
Department of Materials Science and Engineering, Stanford University, Stanford, CA, USA.
Nat Biomed Eng. 2020 May;4(5):507-517. doi: 10.1038/s41551-020-0555-4. Epub 2020 May 11.
Treatment of patients with diabetes with insulin and pramlintide (an amylin analogue) is more effective than treatment with insulin only. However, because mixtures of insulin and pramlintide are unstable and have to be injected separately, amylin analogues are only used by 1.5% of people with diabetes needing rapid-acting insulin. Here, we show that the supramolecular modification of insulin and pramlintide with cucurbit[7]uril-conjugated polyethylene glycol improves the pharmacokinetics of the dual-hormone therapy and enhances postprandial glucagon suppression in diabetic pigs. The co-formulation is stable for over 100 h at 37 °C under continuous agitation, whereas commercial formulations of insulin analogues aggregate after 10 h under similar conditions. In diabetic rats, the administration of the stabilized co-formulation increased the area-of-overlap ratio of the pharmacokinetic curves of pramlintide and insulin from 0.4 ± 0.2 to 0.7 ± 0.1 (mean ± s.d.) for the separate administration of the hormones. The co-administration of supramolecularly stabilized insulin and pramlintide better mimics the endogenous kinetics of co-secreted insulin and amylin, and holds promise as a dual-hormone replacement therapy.
用胰岛素和普兰林肽(一种胰岛淀粉样肽类似物)治疗糖尿病患者比仅用胰岛素治疗更有效。然而,由于胰岛素和普兰林肽的混合物不稳定,必须分开注射,因此只有 1.5%需要速效胰岛素的糖尿病患者使用胰岛淀粉样肽类似物。在这里,我们表明,用葫芦[7]脲- 接枝聚乙二醇对胰岛素和普兰林肽进行超分子修饰,改善了双激素治疗的药代动力学,并增强了糖尿病猪餐后胰高血糖素的抑制作用。在 37°C 连续搅拌下,共制剂的稳定性超过 100 小时,而在类似条件下,商业胰岛素类似物制剂在 10 小时后就会聚集。在糖尿病大鼠中,稳定共制剂的给药使普兰林肽和胰岛素的药代动力学曲线的重叠面积比从单独给予激素时的 0.4±0.2 增加到 0.7±0.1(平均值±标准差)。超分子稳定的胰岛素和普兰林肽的共同给药更好地模拟了内源性共分泌胰岛素和胰岛淀粉样肽的动力学,有望成为一种双激素替代疗法。