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Quality by design (QbD) driven development of sinensetin embedded hydrogel for diabetic wound healing applications.
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1  Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Mesra, Ranchi, Jharkhand - 835215, India
Academic Editor: Antonio Vassallo

Abstract:

Diabetic wounds represent one of the most serious complications of diabetes mellitus, often leading to delayed healing and increased risk of infection. Conventional therapies are limited in efficacy, which necessitates the development of novel therapeutic strategies. In this study, we aim to design and evaluate a sinensetin-loaded hydrogel formulation for the management of diabetic wounds, applying the principles of Quality by Design (QbD) to optimize its development. Sinensetin, a pentamethoxyflavone found in the leaves of Orthosiphon aristatus (Cat’s whiskers) and citrus fruit peels, has been reported to possess strong antioxidant, anti-inflammatory, and antimicrobial properties, making it a promising candidate for wound healing applications. The hydrogel will be formulated and characterized through advanced techniques, including FESEM, FT-IR, XRD, DSC, TGA, viscosity, pH, spreadability, in vitro drug release, entrapment efficiency and texture analysis. In vitro studies will be performed to assess antioxidant, antimicrobial, and anti-inflammatory activities. For in vivo evaluation, diabetes will be induced in rats using a high-fat diet (HFD) combined with a low-dose STZ injection, followed by excision wound creation. Percentage wound contraction, re-epithelialization, collagen deposition, biochemical study and histopathological features will be studied alongside molecular assays of inflammatory cytokines and growth factors. This work is expected to provide scientific evidence for the wound healing efficacy of sinensetin hydrogel, highlighting its potential as a novel therapeutic approach for diabetic wound management.

Keywords: Diabetic wound; sinensetin; hydrogel; antioxidant; anti-inflammatory.

 
 
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