Non-clinical safety study of a sugarcane bacterial cellulose hydrogel

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.

Antibacterial and Antibiofilm Potential of Bacterial Cellulose Hydrogel Containing Vancomycin against Multidrug-Resistant Staphylococcus aureus and Staphylococcus epidermidis

“…Moreover, it is important to highlight that the hydrogel developed by Zoogloea sp. has undergone comprehensive evaluation in toxicity tests, as described by Pinto et al [34], and safety studies conducted by Silva et al [24]. Clinical research led by Silva et al [26] confirmed not only the safety of the product but also its high capacity to promote wound healing in chronic venous ulcers in the lower extremities, showing significant reductions in wound area, improved healing rates, and positive patient outcomes when compared to standard dressings.…”

“…The structure of hydrogel is similar to the extract of an extracellular matrix and soft tissues, which presents a distinct three-dimensional conformation of nanofibrils and microfibrils that enables the adhesion of compounds due to the hydroxyl groups that make up its surface [19][20][21][22]. A hydrogel produced from sugar cane molasses has been tested in different medical and biomedical areas, showing promising results, including stability due to sugar polymerization, low toxicity, biocompatibility, and efficiency for tissue remodeling [23][24][25][26].…”

Segurança e eficácia da celulose bacteriana obtida a partir do melaço de cana-de-açúcar no processo de cicatrização e remodelamento tecidual: uma revisão narrativa

“…Na avaliação de biomateriais para dispositivos médicos, testes em animais são procedimentos inerentes para estimar a biocompatibilidade de um novo biomaterial antes do seu uso clínico de modo que sejam verificados efeitos tóxicos, sistêmicos e locais. A toxicidade in vivo pode ser avaliada por sinais clínicos e testes laboratoriais de hematologia, bioquímica sérica, avaliação de tecidos e órgãos, análise histopatológica, e investigação de reação inflamatória (ISO 10993, 2010) Os estudos pré-clínicos, in vivo, desenvolvidos com a CB investigaram a reatividade cutânea (Lucena et al, 2015), a bicompatibilidade e reação de sensibilidade local (Pita et al, 2015), a citotoxicidade e potencial genotóxico (Pinto et al, 2015) e os efeitos adversos locais e sistêmicos (Silva et al, 2020). Nestes estudos foram usados como parâmetros avaliativos sinais clínicos, atividade enzimática, resposta inflamatória, tempo de cicatrização, análise histopatológica e reatividade cutânea/subcutânea frente a aplicação da CB na apresentação de membrana e hidrogel a 0,8% (em animais domésticos e roedores).…”