Abstract
A hydrogel of bacterial cellulose of 0.8%, biopolymer produced from sugarcane molasses and synthesized from a bacteria called Zoogloea sp., was analyzed for its composition and tested by two routes of administration, subcutaneous and intraperitoneal, to clarify the local and systemic adverse effects after skin implantation in Wistar rats (24 males, 24 females, 55 days old). Analysis of two samples of BC films indicates carbon (42.94%; 43.43%), hydrogen (6.73%; 6.76%), nitrogen (0.28%, 0.23%) and oxygen (50.05%, 49.58%). No abnormal behavior, clinical signs of chronic toxicity or inflammation were observed. There was no change in liver injury biomarker levels (ALT, AST and ALP), as well as in renal histology, where it was evaluated to signs of tubular cell injury, glomerular or vascular damage, and renal morphometry, in which it was quantified the number of renal corpuscles, the number of cells per glomerulus and the capsular space area. Thus, the absence of signs and symptoms of toxicity suggests that subcutaneous or intraperitoneal injections of these polymers may be used in clinical situations.
Highlights
Bacteria-synthesized polysaccharides have suitable properties for biomedical applications (Fragoso et al, 2014; Silveira et al, 2016; Gonçalves-Pimentel et al, 2018)
Disposable hypodermic syringes containing the bacterial cellulose hydrogel (BC) 0.8% hydrogel ready for use were supplied as single units wrapped and sealed with surgical paper tape that were sterilized by gamma rays (25kGy) at the Laboratory of Metrology of the Department of Nuclear Energy of the Federal University of Pernambuco (UFPE)
This proportional elementary composition, except for a small content of nitrogen, corresponds to that expected for carbohydrates, the minimal formula of which is (CH2O)n, where n is the number of units of carbon. 1H NMR spectra of BC hydrogel detected a single intense signal at δ 4.72 ppm that can be attributed to the presence of water and hydroxyl groups
Summary
Bacteria-synthesized polysaccharides have suitable properties for biomedical applications (high degree of purity, biodegradability, elasticity, and flexibility) (Fragoso et al, 2014; Silveira et al, 2016; Gonçalves-Pimentel et al, 2018). The biocompatibility and lack of cytotoxicity of this biopolymer in preliminary tests, allied to its relatively low production costs, prompted research on the possible medical applications of this new and promising biomaterial (Lucena et al, 2015; Pinto et al, 2016; Donini et al, 2018). Experimental and clinical studies suggested that sugarcane bacterial cellulose hydrogel (BC) is a biomaterial useful for a variety of surgical procedures, such as correction of hypospadias and other uses in urologic surgery (Martins et al, 2013; Lima et al, 2015; Lucena et al, 2015; Lima et al, 2017), treatment of fecal incontinence after anal trauma (Cavalcante et al, 2018), treatment of eviscerated eyes (Cordeiro-Barbosa et al, 2012), repair of tympanic membrane perforation (Silveira et al, 2016), vascular surgery procedures (Barros-Marques et al, 2012), pressure injury (Oliveira et al, 2019), orthopedic surgery (Albuquerque et al, 2011), and neurosurgery (Lima et al, 2017). The aim of this study was to evaluate the cellulose exopolysaccharide produced from sugarcane by a non-clinical safety study to shed light on the local and systemic adverse effects of the bacterial cellulose 0.8% hydrogel after implantation under the skin (subcutaneous administration) or injection into the peritoneal cavity of Wistar rats
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