Formulation, optimization and validation of floating oral in situ gel of Ivabradine hydrochloride.

Aim: Ivabradine hydrochloride is a hyperpolarized activated channel blocker used for symptomatic treatment of chronic angina pectoris. However, due to its short half-life it is rapidly eliminated from systemic circulation. Materials & methods: Floating in situ gel was formulated using sodium alginate and HPMC K 100 M by pH induced ion gelation technique employing 32 factorial design for optimization and evaluated.

Results

The in situ formulation remained buoyant in gastric environment for 12 h. Optimized formulation sustained and prolonged drug release in comparison with marketed product. Kinetic analysis of drug release indicated non fickian mechanism. Short term stability studies showed no significant changes indicating good formulation stability.

Conclusion

Formulated in situ solution shows potential effective sustained release over a prolonged period of time.