Abstract
Chronic wounds are a significant and growing health problem, and clinical treatment is often a painful experience. A topical dosage form would be optimal to treat this pain. Poloxamer 407, a thermosensitive polymer that is a liquid at low temperatures but gels at higher temperatures, is well suited to administer topical analgesics to chronic wound sites. The goal of this study was to evaluate the gelation and drug delivery properties of poloxamer 407 gels containing diclofenac sodium for potential use in chronic wound analgesic delivery. The gelation properties of poloxamer formulations were evaluated rheologically. Drug delivery properties of poloxamers loaded with diclofenac sodium were evaluated using snakeskin dialysis membranes, intact porcine ear skin, and porcine ear skin impaired via tape stripping. A commercial gel product and a solution of diclofenac sodium in water were used as control formulations. Poloxamer concentration and gelation temperature varied inversely, and the addition of higher concentrations of diclofenac sodium correlated to significant increases in poloxamer gelation temperature. Poloxamer solutions were effective in limiting the permeation of diclofenac sodium through membranes with impaired barrier properties, and delivery of diclofenac sodium from poloxamer 407 did not vary significantly from delivery observed from the commercial gel product. The amount of drug delivered in 24 h did not change significantly with changes in poloxamer 407 concentration. The results of this study indicate that poloxamer 407 may be a useful formulation component for administration of an analgesic product to a chronic wound site.
Highlights
The skin is the largest organ of the body and is key to maintaining homeostasis, with a unique layered structure that provides a barrier to harmful external materials and maintains body temperature and moisture [1,2,3]
InIn these studies, we investigated the rheological properties and drugand release profiles of poloxamer these studies, we investigated the rheological properties drug release profiles of gels co-formulated with diclofenac sodium and quantified permeation through intact and impaired poloxamer 407 gels co-formulated with diclofenac sodium and quantified permeation through intact and impaired porcine
For a poloxamer formulation to be clinically useful within a chronic wound, it must form a gel within the wound site
Summary
The skin is the largest organ of the body and is key to maintaining homeostasis, with a unique layered structure that provides a barrier to harmful external materials and maintains body temperature and moisture [1,2,3]. Pain management correlates with shortened wound healing times and improved patient outcomes and is key to improving the quality of life for patients suffering from chronic wounds [5,6,7,8]. Systemic analgesic compounds such as orally administered non-steroidal anti-inflammatory drugs (NSAIDs) and opioids can provide pain relief.
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