Abstract

Pooja BC*, T S Nagaraja, Yogananda R, Maruthi N, Subhan Sab

ABSTRACT

The present work involves the formulation of sublingual films of Clopidogrel, a BCS Class II drug, faces a major problem due to its poor bioavailability in oral dosage form. To increase solubility and bioavailability, Solid dispersion were prepared which is in the ratio 1:1, 1:3 and 1:5. The solubility of prepared solid dispersion varied from 0.09mg/ml to 0.59mg/ml (SD1 to SD6). As compared to PVA, the solid dispersion prepared with CMC showed greater solubility which is in the ratio of 1:5. The drug content of prepared formulations of clopidogrel bisulfate solid dispersion with CMC was observed 94.9% and for solid dispersions with PVA, it was found to be 85.2%. Films prepared with HPMC E15 different concentrations were found to be flexible, smooth, translucent, non-sticky and homogeneous than HPMC E5 and HPMC E50. Folding endurance, thickness and tensile strength indicates that the Fast-dissolving Sublingual Films were mechanically stable. The Surface pH of all formulations was in the range of 6-7 and it is close to the saliva pH, these films are suitable for sublingual route with no irritation to the mucosa. The In-vitro drug release studies shows that release from the Fast-Dissolving Sublingual Films gets successfully released for over 10 mins. Drug release mechanism indicates that formulations had higher linearity in First order kinetics. Based on the results obtained from the physicochemical parameters and in-vitro drug release F2 was found to be best formulation.