Abstract

FORMULATION, EVALUATION AND OPTIMIZATION OF FLASH DISSOLVING ORAL FILM OF AMLODIPINE BESYLATE

Rajendra Ayer*

Abstract

The aim of the present study was to formulate, evaluate and optimize flash dissolving oral film of Amlodipine besylate by solvent casting technique. The film was formulated using different ingredients such as film forming polymer, plasticizer, superdisintegrant, sweetening agent and saliva stimulating agent. The film was evaluated for weight variation, thickness, folding endurance, surface pH, content uniformity, disintegration time and In-vitro dissolution. Plackett Burman Design (PBD) with 6 factors and 12 experimental runs was used for screening of the variable such as Hydroxypropyl methyl cellulose (HPMC), Polyethylene glycol (PEG), Crospovidone (CP), Croscarmellose sodium (CCS), Aspartame (ASP) and Citric acid (CA). Among the excipients, Hydroxypropyl methyl cellulose (HPMC), Polyethylene glycol (PEG) and Croscarmellose sodium (CCS) showed significant effect on disintegration of film hence are selected for further optimization. Box Behnken Design (BBD) with 3 factors (Hydroxypropyl methyl cellulose, Polyethylene glycol and Croscarmellose sodium) and 15 experimental runs was employed for optimization of the formulation. For selection of optimal formulation Contour plot, overlaid contour plot, surface plot and response optimizer plot were drawn and analyzed taking dissolution at 5 minute as response. The optimum formulation was selected which contains 30% of Hydroxypropyl methyl cellulose, 10% of Polyethylene glycol and 4.4 % of Croscarmellose sodium. Thus Flash dissolving film of Amlodipine besylate can be formulated using solvent casting technique for the better patient compliance and faster action of the drug.

Keywords: Flash dissolving oral film, Amlodipine besylate, Hydroxypropyl methyl cellulose, Polyethylene glycol, Croscarmellose sodium and Solvent casting