Development and Evaluation of Muco-Adhesive Ciprofloxacin Bi-Layer Tablet for Extended Drug Release

The present study was undertaken to design and evaluate bilayer tablets of ciprofloxacin hydrochloride containing an immediate release layer and a mucoadhesive extended release layer. Tablets were prepared by direct compression method using Carbopol 934P, Hydroxylpropyl methylcellulose -15 cps (HPMC-15cps), Methocel K4M and Sodium Carboxy methylcellulose (Na-CMC) as mucoadhesive polymer. All the formulations showed uniform weight, thickness, crushing strength and content uniformity. Tablets were evaluated by mucoadhesive strength, ex-vivo residence time and in vitro drug release profile. Methocel K4M, HPLC-15 cps and Carbopol 934P based formulation (F-3, F-2 and F-1) showed maximum mucoadhesive strength (74.5 gm to 61.81 gm). Ex vivo residence time was 8.5 hr for F-3 and 6.75 hr for F-1. Time required for 100% drug release from F-1, F-2, F-3 and F-4 were 5 hr, 3 hr, 7 hr and 3 hr respectively. Release profile was compared with a commercial ciprofloxacin tablet. Higher sustained drug release was found in all formulations than the commercial product.