Formulation, Optimization and Characterization of Novel Modified Release Gel Formulation of Dexibuprofen Using Full Factorial Design

Abstract

The aim of the study is to prepare Dexibuprofen modified release gel for topical delivery to provide the drug release in a modified manner, decreasing the oral side effects of the drug and improving the stability. Dexibuprofen, an anti-inflammatory drug, was used to design Novel Modified Release Gel Formulation to avoid its first pass effect as well as to increase its bioavailability with decline in dosing rate and to reduce its adverse effects. Skin is the largest, most extensive and accessible organ for topical administration of drug on human body, compared to other organs for drug delivery. Skin is most important route of topical drug delivery system. Topical application of dosage forms offers several advantages of delivering the drug directly to the site of action and acts for an extended period of time. In this study, Dexibuprofen gel was prepared by aqueous process. Drug-Excipient compatibility study was performed for the selected excipients. A sum of 6 batches (Batch No. from F001 to F006) were arranged by means of different polymers for prototype development and these are evaluated for various parameters. Batch No. F006 was found to have better quality characteristics hence composition of this batch was taken forward for optimization. Formulation was optimized using full factorial design. Four independent factors were optimised with varying levels of Chitosan, Sepineo P 600, Lactic acid and stirrer rpm. JMP Software has given 19 trials with 3 centre points and three responses owing to quality characteristics of gel formulations namely pH, viscosity and spreadability. An Interaction between Independent factors and responses were studied. The stability studies were carried out for prepared gel formulation as per ICH guidelines. The prepared Dexibuprofen gel was evaluated for various parameters and it shows good spreadability of B.No. F006 and it is concluded that the formulation could be very promising for the topical use to relieve pain and reduce the inflammation.