A semi-solid drug delivery system for epidermal growth factor in corneal epithelial wound healing
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PURPOSE: To examine the effects of EGF, delivered from a semi-solid drug delivery system, on corneal epithelial wound healing following anterior keratectomy wound creation in the eyes of New Zealand white rabbits. METHODS: A semi-solid drug delivery system based on a Carbopol gel was developed. Following creation of a 7.5 mm circular anterior keratectomy wound, 50 microL of either a placebo gel or an EGF-containing gel, was instilled in the inferior fornix. The gel remained in the eye for 8 hours, at which time it was removed. Anaesthesia was maintained for the entire 8-hour period. Wound healing was evaluated by quantitative morphometry. We evaluated 0.04, 0.1, 0.2, 0.4, and 1% EGF concentrations in the gel. Tear EGF concentrations and histology of the healing corneas were also examined. RESULTS: The enhancement factor (ratio of the healing rate with the EGF gel and control gel) was 1.13 +/- 0.12, 1.40 +/- 0.14, 1.29 +/- 0.12, 1.80 +/- 0.22, and 1.09 +/- 0.12 for the gels containing 0.04, 0.1, 0.2, 0.4, and 1% EGF by mass, respectively. The increases in the rate of wound healing were significant with the 0.1, 0.2 and 0.4% gel formulations. Histologically, the 0.4% gels resulted in cellular hyperplasia after 5 days of healing. Differences between the placebo gel-treated and EGF-containing gel-treated eyes were evaluated at both 2 and 5 days. The concentration of EGF in the tears during the treatment period was approximately constant for both the 1% and 0.04% gels. The average tear concentration during the instillation period was 2.87 +/- 0.36 micrograms/mL and 200.61 ng/mL +/- 116.10 for the 1% and 0.04% gels respectively. CONCLUSIONS: Treatment with EGF in a Carbopol gel carrier for a period of 8 hours results in significant wound healing enhancement (p < 0.05). The optimum EGF loading in the gel was determined to be 0.4%. A slow release gel may be an effective way to deliver EGF to the corneal surface.
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