PREPARATION & EVALUATION OF SILVER SULFADIAZINE (SSD) LOADED LIPOSOMAL TOPICAL GEL FORMULATIONS Aim of the Project Work

Silver sulfadiazine (SSD) is a topical antibacterial used as a topical burn cream on burns, including chemical burns especially for second degree & third degree burns. It is typically delivered in a 1% w/w cream or aqueous suspension. To formulate & evaluate liposome based topical gel formulations of drug silver sulfadiazine for the purpose of wound healing To examine the effect of Egg oil in healing of burn wound in animals Comparative study & Statistical analysis of liposomal gel formulations with marketed Silver sulfadiazine cream

Procedure
Multilamellar vesicles of Silver sulfadiazine were prepared by thin film hydration technique using rotary flash evaporator. The liposomes were prepared by using LIPOVA E120 (purified Egg lecithin), cholesterol and Tocopheryl acetate (anti oxidant). The dry lipid film was hydrated with distilled water containing drug SSD. Complete lipid hydration resulted in formation of liposomes. The prepared liposomes were incorporated into Carbopol 934 (1% w/w)gel base such that the prepared gel having 1% w/w SSD concentration.

Optimization of Variables & Characterization

The prepared liposomes & liposomal gel were characterized for their morphological characteristics, particle size and particle size distribution, Percent Drug Entrapped, DSC studies and drug retention study. Wound healing study was performed on male rats. Burn was induced & various liposomal formulations were tested macroscopically as well as Histopathologically. While applying Experimental Design called Box-Behnken Design to optimize formulation variables, maximum entrapment was found with liposomes prepared with drug: LIPOVA E120: cholesterol weight ratio 3:10:2, 8 ml hydration volume and 4 ml of Organic solvent.

Results
Sr. No. 1 2 3 4 5 6 Parameter Microscopy Particle Size Zeta Potential Percent Drug Entrapped Skin Retention Study Wound Healing Study (Macroscopically & Histopathologically) 7 Stability Study (1 month) storage conditions i.e. refrigerated temperature, room temperature Results Liposomes Were found in Spherical Shape 193.51.1 nm -81.8 mV 76.651.06 Liposomal gel formulations were retained in the skin of rats The egg oil (OLEOVA) loaded liposomal gel was found to have maximum healing compare to other tested formulations. Maximum stability was observed at refrigerated temperature (2-8C).

Photomicrograph of Liposomal Formulation

Wound Healing Study Performed on Rats to analyze various Formulations

From the results of wound healing study, the rate of wound healing activity in rats can be figured out in following order: Control (non-treated) < 1% SSD Suspension < Empty liposome < marketed cream (1% w/w SSD) < Optimized liposomal gel < Egg oil containing Liposomal Gel

Conclusion
It was found that liposomal formulations showed more drug retention into skin with compare to non liposomal formulations. The liposomes control the release of drug in skin over 8 hrs of diffusion study. Findings of this investigation suggest that liposomal formulation of SSD can provide consistent and prolonged wound healing effect and is also expected to minimize the side effects due to selective built up of drug concentrations at the site of action. However, the role of the formulation developed under this investigation can only be settled with clinical investigations with emphasis on therapeutic index and side effects followed by pilot scale studies of manufacturing the product for commercial use.