FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF AMLODIPINE BESYLATE
Mukesh P.Ratnaparkhi* and Ashvini S.Kadam
ABSTRACT
Mouth dissolving drug delivery systems were first developed in the
late 1970s as an alternative to tablets, capsules, and syrups. Fast
dissolving oral films (FDOFs) are the most advanced form of oral solid
dosage form due to more flexibility and comfort. It improve the
efficacy of APIs by dissolving within minute in oral cavity after the
contact with less saliva as compared to fast dissolving tablets, without
chewing and no need of water for administration. In the present
research, rapidly dissolving films of Amlodipine Besylate were
developed using HPMC E-5 & Pullulan as film forming polymers.
HPMC & Pullulan are water soluble synthetic & natural polymers
which were used as a film former from many years, PEG 400 and PEG 4000 used as a
plasticizer. These two variables were studied at two levels using surface response method.
The films of Amlodipine Besylate were prepared by solvent casting method using Ethanol &
Distilled water as solvents. The prepared films were evaluated for weight, thickness, folding
endurance and disintegration time. The in vitro and ex- vivo dissolution study of the
optimized formulation was found to be 95.98% in 2 minutes and 88.49% in 3 minutes
respectively. The prepared films exhibited good integrity and thickness. DSC and FTIR
studies showed no drug polymer interaction.
Keywords: Fast dissolving films, Amlodipine Besylate, HPMC, Pullulan, Solvent casting.
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