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Formulation and Evaluation of Oral Dissolving Films of Amlodipine Besylate Using Blends of Starches With Hydroxypropyl Methyl Cellulose.

BACKGROUND
Natural polymers serve as cheap, non-toxic, biocompatible excipients in oral drug delivery. These advantages inform their uses in the design of drug dosage forms.


OBJECTIVES
The aim of the study was to prepare and evaluate oral dissolving films of amlodipine besylate, an anti-hypertensive drug, using starch/polymer blends.


MATERIAL AND METHODS
Bambara nut (BAM) and the African yam bean (AYB) starches were individually blended with hydroxypropyl methyl cellulose (HPMC). The material and rheological properties of the blends were determined. Amlodipine besylate was incorporated by dispersion and films were prepared by solvent evaporation method and evaluated for mechanical and drug release properties.


RESULTS
The BAM/HPMC blends had higher viscosity values than the corresponding AYB/HPMC blends. All the blends gave a Hausner ratio above 1.25 and Carr's index above 22. Blends of ratio 1 : 1 and 2 : 1 produced good films and were subsequently evaluated. All films disintegrated within 15 mins but had poor folding endurance. BAM/HPMC (1 : 1) and AYB/ /HPMC (2 : 1) released all of the drug content within 30 min. The ranking for dissolution profile was AYB/HPMC (2 :1 ) > BAM/ /HPMC (1 :1 ) > BAM/HPMC (2 : 1) > AYB/HPMC (1 : 1). The type and ratio of starch in the blend influenced the drug release pattern of the films.


CONCLUSIONS
Starch/HPMC blend ratios of 1 : 1 and 2 : 1 were found suitable for the formulation of oral dissolving film of amlodipine besylate with good disintegration time and drug release profile.