Self-Assembled, Dilution-Responsive Hydrogels for Enhanced Thermal Stability of Insulin Biopharmaceuticals,ACS Biomaterials Science & Engineering

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Self-Assembled, Dilution-Responsive Hydrogels for Enhanced Thermal Stability of Insulin Biopharmaceuticals
ACS Biomaterials Science & Engineering ( IF 5.4 ) Pub Date : 2020-11-17 , DOI: 10.1021/acsbiomaterials.0c01306
Catherine M Meis ₁ , Erika E Salzman ₁ , Caitlin L Maikawa ₂ , Anton A A Smith _{1,

3} , Joseph L Mann ₁ , Abigail K Grosskopf ₄ , Eric A Appel _{1,

2,

5,

6}

Affiliation

Biotherapeutics currently dominate the landscape of new drugs because of their exceptional potency and selectivity. Yet, the intricate molecular structures that give rise to these beneficial qualities also render them unstable in formulation. Hydrogels have shown potential as stabilizing excipients for biotherapeutic drugs, providing protection against harsh thermal conditions experienced during distribution and storage. In this work, we report the utilization of a cellulose-based supramolecular hydrogel formed from polymer–nanoparticle (PNP) interactions to encapsulate and stabilize insulin, an important biotherapeutic used widely to treat diabetes. Encapsulation of insulin in these hydrogels prevents insulin aggregation and maintains insulin bioactivity through stressed aging conditions of elevated temperature and continuous agitation for over 28 days. Further, insulin can be easily recovered by dilution of these hydrogels for administration at the point of care. This supramolecular hydrogel system shows promise as a stabilizing excipient to reduce the cold chain dependence of insulin and other biotherapeutics.

中文翻译：

用于增强胰岛素生物药物热稳定性的自组装、稀释响应水凝胶

生物治疗剂目前在新药领域占据主导地位，因为它们具有出色的效力和选择性。然而，产生这些有益特性的复杂分子结构也使它们在配方中不稳定。水凝胶已显示出作为生物治疗药物的稳定赋形剂的潜力，可在分销和储存过程中提供针对严酷热条件的保护。在这项工作中，我们报告了利用由聚合物-纳米颗粒 (PNP) 相互作用形成的基于纤维素的超分子水凝胶来封装和稳定胰岛素，胰岛素是一种广泛用于治疗糖尿病的重要生物治疗剂。在这些水凝胶中封装胰岛素可防止胰岛素聚集并通过超过 28 天的高温和连续搅拌的压力老化条件保持胰岛素生物活性。此外，通过稀释这些水凝胶可以很容易地回收胰岛素，以便在护理点给药。这种超分子水凝胶系统有望作为一种稳定赋形剂，以减少胰岛素和其他生物治疗药物的冷链依赖性。

更新日期：2020-11-17

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