Design and optimization of a novel herbosomal-loaded PEG-poloxamer topical formulation for the treatment of cold injuries: a quality-by-design approach.

The spectrum of cold injuries ranges from frostnip, chilblains to severe frostbite. Cold injuries occur upon prolonged exposure to freezing temperature and are pathologically a combination of ice crystal formation in the tissue resulting in inflammation, thrombosis and ischemia in the extremities, often necessitating limb amputation in extreme cases due to tissue necrosis. Severe forms of frostbite are a cause of major concern to patients as well as the treating physician.