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

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.