Balancing sterilization and functional properties in Poloxamer 407 hydrogels: comparing heat and radiation techniques.

IF 5.6 1区 医学 Q1 MATERIALS SCIENCE, BIOMATERIALS
Regenerative Biomaterials Pub Date : 2025-01-22 eCollection Date: 2025-01-01 DOI:10.1093/rb/rbaf005
Angela De Lauretis, Anne Eriksson Agger, Antara Pal, Jan Skov Pedersen, Szymon Mikolaj Szostak, Reidar Lund, Ståle Petter Lyngstadaas, Jan Eirik Ellingsen, Dirk Linke, Håvard Jostein Haugen
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引用次数: 0

Abstract

Poloxamer 407, also known as Pluronic® F127, is gaining interest in the cosmetic, biomedical and pharmaceutical fields for its biocompatibility, safety and thermo-sensitive properties. Ensuring sterility is critical in clinical applications, and sterilization is often preferred over aseptic processing. However, sterilization can impact the functional properties of the hydrogel. In this study, we investigate the effects of steam heat (121°C, 20 min), dry heat (160°C, 1 h), gamma irradiation (25 kGy) and electron beam (e-beam) irradiation (15 and 25 kGy) on a 30% w/v Poloxamer 407 hydrogel formulation. Our analysis encompasses gelling properties, pH, Fourier-transform infrared spectroscopy, gel permeation chromatography, small-angle X-ray scattering, rheology, swelling, degradation by-products and lactate dehydrogenase release of the sterilized hydrogels, comparing them to a non-sterile counterpart. We demonstrated that heat sterilization alters the hydrogel's gelling and structural properties due to water evaporation and oxidation under harsh temperature conditions, especially when applying the dry heat method. Gamma irradiation proved unsuitable, resulting in an acidic and cytotoxic hydrogel due to oxidative degradation. In contrast, e-beam irradiation preserves the hydrogel's elasticity, gelling and structural properties while enhancing mechanical resilience and moderating swelling. Therefore, e-beam irradiation within the 15-25 kGy range appears to be the most suitable method for sterilizing a 30% w/v Poloxamer 407 hydrogel.

平衡波洛沙姆407水凝胶的杀菌和功能特性:热和辐射技术的比较。
Poloxamer 407,也被称为Pluronic®F127,因其生物相容性,安全性和热敏性而在化妆品,生物医学和制药领域引起了人们的兴趣。确保无菌性在临床应用中至关重要,灭菌通常优于无菌处理。然而,灭菌会影响水凝胶的功能特性。在这项研究中,我们研究了蒸汽加热(121°C, 20分钟)、干热(160°C, 1小时)、伽马辐射(25 kGy)和电子束(15和25 kGy)对30% w/v波洛沙姆407水凝胶配方的影响。我们的分析包括胶凝特性、pH值、傅里叶变换红外光谱、凝胶渗透色谱、小角度x射线散射、流变学、溶胀、降解副产物和乳酸脱氢酶释放,并将其与非无菌水凝胶进行比较。我们证明了在恶劣的温度条件下,特别是当使用干热法时,由于水蒸发和氧化,热灭菌改变了水凝胶的凝胶和结构性质。伽马辐射被证明是不合适的,由于氧化降解导致酸性和细胞毒性水凝胶。相比之下,电子束辐照保留了水凝胶的弹性、胶凝和结构特性,同时增强了机械回弹性,减缓了膨胀。因此,15-25 kGy范围内的电子束辐照似乎是灭菌30% w/v poloxam407水凝胶的最合适方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Regenerative Biomaterials
Regenerative Biomaterials Materials Science-Biomaterials
CiteScore
7.90
自引率
16.40%
发文量
92
审稿时长
10 weeks
期刊介绍: Regenerative Biomaterials is an international, interdisciplinary, peer-reviewed journal publishing the latest advances in biomaterials and regenerative medicine. The journal provides a forum for the publication of original research papers, reviews, clinical case reports, and commentaries on the topics relevant to the development of advanced regenerative biomaterials concerning novel regenerative technologies and therapeutic approaches for the regeneration and repair of damaged tissues and organs. The interactions of biomaterials with cells and tissue, especially with stem cells, will be of particular focus.
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