Novel Mucoadhesive Gastro Retentive Drug Delivery System of Ranitidine Hydrochloride

Novel gastro retentive drug delivery system (GRDDS) of Ranitidine hydrochloride prepared in the present study based on unfolding mechanism. Ranitidine Hydrochloride, a H2 antagonist with a narrow absorption window was selected for this novel GRDDS due to its low bioavailability (50%) which might be due to colonic degradation by colonic bacteria and also low biological half-life of 2.5–3 hours necessitates the development of effective GRDDS of ranitidine. Hence in the present study Ranitidine hydrochloride films were prepared by solvent-casting method and by using polymers like HPMC K4M, Carbopol 934, Eudragit L100 and RLPO and plasticizer; polyethylene glycol 400. The film with zigzag folding in the capsule was shown to unfold in the stomach and provide drug release up to 8hours in the acidic medium. Films were evaluated by various parameters like film thickness, weight variation, Uniformity of drug content, swelling index, folding endurance, unfolding time, elongation at break, tensile strength, mucoadhesion study, in vitro drug release, in vivo gastric residence time, DSC, SEM, and IR. Formulation batch F5 was considered as optimized batch due to its good mucoadhesive time(487min) and drug release was found in controlled manner; almost98.12% drug release up to 8 hours. Also in vivo study (Gastric residence Time in Rabbit)of optimized batch and mucoadhesion study (using Goat stomach mucosa) indicates that this Novel patch of Ranitidine hydrochloride was found to be mucoadhesive and profound basis for effective GRDDSas compared to other gastro retentive techniques due to its unfolding mechanism.