Safety profile of silver sulfadiazine-bFGF-loaded hydrogel for partial thickness burn wounds

Abstract

In the present investigation, the safety of novel combinational silver sulfadiazine-bFGF-loaded hydrogel was assured by performing acute skin irritation, sensitization, acute dermal toxicity, and eye irritation in compliance with the Organization for Economic Co-operation and Development guidelines. In the skin irritation study, placebo, test, and positive control (0.8% w/v aqueous solution of formaldehyde) were applied on New Zealand rabbits and monitored for abnormal skin responses including erythema and edema. The placebo and test formulation did not induce any adverse reactions and were classified as nonirritating materials. In the skin sensitization test, guinea pigs were sensitized by positive control (0.1% w/v 1-chloro-2,4-dinitrobenzene in 10% of propylene glycol as a standard skin sensitizing agent), placebo, and test formulations. Weak sensitization was observed in the placebo and test formulation treated groups. Additionally, acute dermal toxicity test was performed in Wistar rats, where no signs of toxicity were observed in biochemical, hematological, and histopathological studies. Moreover, the acute eye irritation test was carried out in rabbits and no abnormal clinical signs were evident in the cornea or iris. As a whole, these findings suggest that the hydrogel formulation does not cause any skin irritation, skin sensitizationand dermal toxic effects, and eye irritation following dermal and ocular applications, respectively. Therefore, all the findings obtained from this preclinical study indicated that this hydrogel formulation is nontoxic and safe for use in animal models.

Keywords:

• Basic fibroblast growth factor
• silver sulfadiazine
• hydrogel
• second-degree burn
• dermal irritation
• skin sensitization
• acute dermal toxicity

Acknowledgements

One of the authors, Srijita Chakrabarti, extends her gratitude to Defence Research Laboratory (DRL), Defence Research and Development Organization (DRDO), Ministry of Defence, Govt. of India for providing necessary facilities and financial support in the form of research fellowship. The author also gratefully acknowledges Department of Pharmaceutical Sciences, Dibrugarh University for providing administrative support to carry out her PhD work. Finally, all anonymous reviewers are also gratefully acknowledged for their specific comments that help a lot in improving this manuscript.

Disclosure statement

The authors declared no conflicts of interest with respect to the research, authorship, and/or publication of this article, and received no financial support for the research.