Effect of Cyclodextrins Inclusion Complex and Gelling Agents on the Release of Ciprofloxacin HCL from Topical Gel Formulations

Abstract

Background: Topically applied drugs have the advantage of supplying a higher concentration of the drug to the skin than systemically applied medications.  The aim of this study was to develop and evaluate a gel formulation of ciprofloxacin hydrochloride (CP-HCL), also to provide a topical treatment for various bacterial skin infections.

Materials and methods: In order to improve the dissolution properties of CP-HCL, the physicochemical properties of CP-HCL:cyclodextrins (CDs) binary systems were studied in both solution and solid states after preparation of the complexes by two methods: simply by physical mixture and kneading methods. CP-HCL:CDs physical mixture and kneaded complexes were prepared and characterized using FTIR ,DSC and SEM comparing with CP-HCL as received. Different gel bases and concentrations of hydroxypropylmethylcellulose (HPMC), sodium carboxymethylcellulose (Na CMC), and sodium alginate (Na Alginate) were used to formulate CP-HCL and its CDs complexes .

Results: The results showed that inclusion complexation occurred for both kneaded and physically mixed CP-HCL with CDs. Almost all of the 19 formulations produced had suitable physicochemical properties, with formula F9, which included a CP-HCL:BCD physical mixture complex and a base consisting of a 10% w/w HPMC gel formulation, providing a good viscosity and drug release properties. Color, consistency, pH, rheological and kinetic properties, skin permeability, and drug release pattern were among the parameters examined. Furthermore, the antibacterial activity of CP-HCL and CP-HCL:CDs complexes, as well as gel formula containing 10% w/w HPMC, was investigated.

Conclusion: Ciprofloxacin and its complexes were successfully incorporated into the various topical gel preparations which showed promising results for the treatment of skin infections.