COMPARATIVE STUDY OF DIFFERENT FORMULATIONS OF ACECLOFENAC AS A TOPICAL DRUG DELIVERY SYSTEM AND IT’S IN VITRO AND IN VIVO CHARACTERIZATION

Aceclofenac is new NSAID which demonstrates its anti-inflammatory and analgesic activity in a concentration of 1.5 %. Topical mode of administration help to avoid typical side effects associated with oral administration of NSAIDS such as irritation and ulceration to gastric mucosa. Hence, an attempt has been made to prepare topical formulations using various dermatological bases and to evaluate release properties and improved stability throughout its shelf life. Cream, gel and emulgel topical formulations were formulated and characterized for its physicochemical parameters such as pH, spread ability, rheological properties and occlusivity. The in-vitro permeation potential of Aceclofenac was performed through Dow Corning 7-4107 silicone elastomer membrane using Franz type diffusion cell. The in-vitro permeation rate of drug from silicone cream base was significantly higher compared to other vehicles. The in-vivo animal study was performed on croton oil induced ear edema model. Developed Aceclofenac cream formulation showed 66.67% inhibition of ear edema which was significantly higher than other formulation. The stability study of Aceclofenac formulations was performed at 25°C/60 % RH, 30°C/65 % RH and at 40°C/75 % RH conditions. Stability study revealed that Aceclofenac possessed higher stability in silicone cream formulation compared to gel and emulgel formulation. Hence, silicone cream base is a stable and efficient vehicle for delivery of Aceclofenac through dermal route.