Gel and hydrogel dressings with antibacterial and reparative properties based on animal-derived materials: pharmaceutical-technological and regulatory aspects (review)

Abstract

Introduction. Chronic, burn, postoperative and infected wounds require dressings that not only maintain a moist environment, but also help control bacterial contamination, inflammation, exudation and tissue regeneration. Gel and hydrogel dressings based on animal-derived biopolymers are of interest for pharmaceutical industry because their properties can be adjusted through the choice of raw material, crosslinking method, matrix composition and various modifications. Text. This review discusses six biopolymer platforms: collagen, gelatin, chitosan, hyaluronic acid, keratin and silk fibroin. The focus is placed not only on their antibacterial and reparative properties, but also on the technological parameters that determine their practical applicability: molecular weight, degree of modification, gelation time, swelling, mechanical strength, adhesion to wet tissue, release profile, biodegradation, sterility, stability and cytocompatibility. Crosslinking methods, approaches to raw material standardization, choice of sterilization method, quality control, the level of preclinical and clinical evidence, and regulatory aspects of medical devices and combination products are also considered. Conclusion. The potential of a hydrogel dressing is determined not only by the biological activity of the material, but also by the reproducibility of its critical quality attributes. The most relevant platforms for further development are those in which composition, manufacturing technology, sterilization, release of active components, safety and intended clinical use are linked at the design stage.