Preparation and Evaluation of Novel Topical Gel Preparations for Wound Healing in Diabetics

Diabetes mellitus is one of the metabolic disorders that impedes normal steps of wound healing process. Recently, statins have been shown to have anticoagulant, immunosuppressive and antiproliferative effects that could conceivably affect wound healing or the risk of wound complications after surgery or injury. The objective of the present study was to develop formulations of Atorvastatin in different types of gels including hydroalcoholic , Hydrogel, microemulsion, Anhydrous, and Alcoholic gel bases. The prepared gels were evaluated for physical appearance, rheological behavior, drug release through a standard cellophane membrane and wound-healing power in streptozotocin-induced diabetic male albino rats. Results showed that all gel formulations showed good and acceptable physical properties. The data obtained from release studies revealed that the total amount of drug released was affected by the nature of the base with maximum drug release was observed with the alcoholic gel base. The rank order of the various gel formulations based on their maximum drug release was alcoholic > hydrogel > hydroalcoholic > anhydrous > microemulsion gel base. Statistical analysis showed that the higher release rate of the first three gel bases was significant (P<0.1) when compared to the anhydrous and the microemulsion gel bases. However, the differences between these three bases were statistically insignificant, (P>0.05). The release kinetics of ATR from the prepared gels, according to various kinetic models gave linear relationships. The best linearity was found in Higuchi ́s equation and first order equation. Results of In-vivo wound healing studies showed a time dependant increase in percent wound contractions which is higher than that produced by the control groups. These contractions were statistically significant (P<0.001), during the first 10 days of the study in case of hydroalcoholic, Hydrogel, and Anhydrous. The anhydrous base showed the highest percent wound contraction with complete wound closure and epithelization was observed on 7 Pth P day of wound induction. All the animals tolerated the applied gels and no signs of irritations were noticed during the whole period of study