Abstract:
The current study focused on the development, optimization and pharmaceutical evaluation of a mouth
dissolving film of Escitalopram 5mg. The designing and optimization of the formulations have been carried out through Design-Expert ® Ver. 9, using central composite response surface methodology. The software generated six optimized formulations have been fabricated via solvent casting method incorporated with HPMC and PEG 400 as Plasticizer. The developed formulations were assessed for various quality attributes including weight variation, drug-excipients interaction, dryness/ tack test, thickness, percent elongation, swelling index, disintegration, folding endurance, surface pH, content uniformity, assay, moisture uptake, stability, and organoleptic properties. A validated spectrophotometric
method has been used to ascertain drug content. The formulations were subjected for stability studies for six months in accordance with ICH accelerated stability studies guidelines. No stability issue has been observed. All the test formulations have shown satisfactory in vitro release of escitalopram whereas most promising results have been exhibited by F5 and F6 formulations. The study concluded that a unique, novel, safe and stable formulation of oral fast dissolving thin films of escitalopram can be formulated with ease. The preparation method was simple and reproducible with scale-up tendency so that it can fulfill the need of the commercial manufacturing process.
