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Amit B. Patil*, R. Narayana Charyulu, C. S. Shastry


The present research study is aimed at developing and characterizing the influence of solubilizing agent such as tween 80 and dimethyl sulfoxide (DMSO) on the morphological and physicochemical characteristic of fast dissolving orodispersible films (FDOF). Pullulan is used as film forming polymer and glycerine was incorporated as plasticizing agent. The embodiment of atenolol as antihypertensive drug, in FDOF was achieved by solvent casting technique. Atenolol is β1 blocker, prescribed widely in diverse cardiac abnormalities. Literature reports that faster disintegration leads to optimum drug release resulting in higher bioavailability. The present research work also attempts to correlate the effect of concentration of pullulan and solubilizing agent on the disintegration time and drug release profile. The atenolol FDOF were characterized for physical appearance, deformation caused during removing from die cavity, disintegration time, in vitro dissolution, etc. The optimum concentration of plasticizer, polymer and solubilizing agent was developed on the basis of flexibility, tensile strength and stickiness of the film. In the presence of solubilizing agent the morphological characters was found to be better than in its absence. Atenolol FDOF showed optimum drug content and folding endurance. The disintegration time of formulation PUD7 film was found to be 10 sec with in vitro release of 99.27 % in 90 sec, which was better than other prepared formulations. Drug-excipients interaction studies performed using FTIR; showed no interaction. Surface pH was found to be neutral, indicating safety of administration. Atenolol FDOF formulated using DMSO showed optimum results as compared to tween 80 and FDOF without solubilizing agent. Thus based on the results it can be concluded that the FDOF formulated using solubilizing agents can enhance the disintegration time and drug release profile.

Keywords: Fast dissolving films, atenolol, pullulan, solubilizing agent.

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