FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF METOPROLOL TARTRATE
Vishakha S. Hastak*, Yogyata S. Pathare, Amruta N. Bajaj
Journal Title:World Journal of Pharmaceutical Research
Aim: Metoprolol tartrate, commonly used as antihypertensive agent,
has poor bioavailability due to extensive first pass metabolism. The
objective of present study is to develop fast dissolving oral films of
Metoprolol tartrate with high porosity which dissolves rapidly in
mouth, using HPMC E15, HPMC E5 and PVA as hydrophilic polymers. Methods: Fast dissolving oral films were prepared by solvent casting method. Different concentrations of all three polymers
(HPMC E15, HPMC E5, and PVA) and their combinations were used to investigate the film forming capacity, thickness and drug content of
films. Glycerin was used as plasticizer. The drug - polymer mixture
was homogenized on magnetic stirrer for 45 min. The casted films were dried for 12 h. to allow complete dryness of films. The fast
dissolving oral films were evaluated for average weight, thickness, pH.
determination, percentage moisture absorption, percentage moisture loss, in-vitro disintegration time, drug content and in-vitro drug release. Drug-excipient interaction was
investigated by FTIR and DSC study. Best formulation was evaluated for stability as per ICH guideline. Results: All films had in vitro disintegration time Less than 73 sec, drug content
were within limits. FTIR study revealed no drug-excipient interaction. A stability study for
optimized F2 formulation as per ICH guideline for 90 days showed no changes in drug content. Conclusion: Therefore, it may be concluded that developed fast dissolving oral films of metoprolol tartrate dissolve rapidly in mouth within 43 sec and showed 97% drug release.