Formulation Development and Evaluation of Mouth Dissolving Film of Ivabradine HCL

Oral film is the latest technology in the production of oral disintegrating dosage forms. They are thin and elegant films of edible water-soluble polymers of various sizes and shapes (such as square, rectangular or disc). The stripes can be flexible or brittle, opaque or transparent. The present investigation was undertaken to formulate Ivabradine HCL oral films. For the treatment of hypertension. F1-F3 were carried out with HPMC E15 cps, PEG 400, sodium saccharin, citric acid and flavor. The films were clear and transparent. The thickness also uniform. The flexibility also good. The films shown good mechanical properties. According to the assay result the drug was properly loaded in the film. The formulated films were more brittleness. Among all the formulations F3 shown good mechanical properties and less disintegration time of 20 seconds. All the parameters of film were found to be satisfactory. And the dissolution profile was found to be desirable and reproducible. The morphological study (SEM) of F3 shows more porous. Therefore, rapid drug release was achieved for the immediate onset of action. The stability studies were performed for about 1 month and 3 months. No significant changes were observed in the thickness, tensile strength, in-vitro disintegration and in-vitro drug release. The film (F3) samples evaluated gave maximum release within 3 minutes indicating the rapid drug release profile which entails in faster onset of action for the medicament. Therefore, the oral films have considerable advantage over the conventional dosage forms