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Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF METOPROLOL TARTRATE

Vishakha S. Hastak *, Yogyata S. Pathare, Amruta N. Bajaj

ABSTRACT

Aim: Metoprolol tartrate, commonly used as antihypertensive agent,has poor bioavailability due to extensive first pass metabolism. Theobjective of present study is to develop fast dissolving oral films ofMetoprolol tartrate with high porosity which dissolves rapidly inmouth, using HPMC E15, HPMC E5 and PVA as hydrophilicpolymers. Methods: Fast dissolving oral films were prepared bysolvent casting method. Different concentrations of all three polymers(HPMC E15, HPMC E5, and PVA) and their combinations were usedto investigate the film forming capacity, thickness and drug content offilms. Glycerin was used as plasticizer. The drug - polymer mixturewas homogenized on magnetic stirrer for 45 min. The casted filmswere dried for 12 h. to allow complete dryness of films. The fastdissolving oral films were evaluated for average weight, thickness, pH.determination, percentage moisture absorption, percentage moisture loss, in-vitrodisintegration time, drug content and in-vitro drug release. Drug-excipient interaction wasinvestigated by FTIR and DSC study. Best formulation was evaluated for stability as per ICHguideline. Results: All films had in vitro disintegration time Less than 73 sec, drug contentwere within limits. FTIR study revealed no drug-excipient interaction. A stability study foroptimized F2 formulation as per ICH guideline for 90 days showed no changes in drugcontent. Conclusion: Therefore, it may be concluded that developed fast dissolving oral filmsof metoprolol tartrate dissolve rapidly in mouth within 43 sec and showed 97% drug release.

Keywords: Fast dissolving oral films, plasticizer, HPMC E15, HPMC E5, PVA.


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